<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01721291</url>
  </required_header>
  <id_info>
    <org_study_id>NIHRCDF</org_study_id>
    <secondary_id>NIHR-CDF-2011-04-053</secondary_id>
    <secondary_id>2011-005544-10</secondary_id>
    <nct_id>NCT01721291</nct_id>
  </id_info>
  <brief_title>Inhaler Lung Deposition in Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <official_title>Improving Inhaler Treatment and Small Airways Assessment in Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties&#xD;
      because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to&#xD;
      provide relief from breathlessness. However, current inhalers are inefficient as they deliver&#xD;
      a 'coarse-mist' of drug-droplets that do not reach the deep airways.&#xD;
&#xD;
      In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive&#xD;
      tracer to track them. We will take images of the lungs to see if the fine-mist droplets reach&#xD;
      the deep airways, and assess if this improves the breathing capacity in our patients. Our&#xD;
      research may allow the development of new, more efficient inhalers to improve treatment for&#xD;
      patients with COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE:&#xD;
&#xD;
      The purpose of the research (or &quot;knowledge gap&quot; this research is designed to fill) is to&#xD;
      understand the fate of inhaled drug within the lungs of COPD patients. Current inhalers in&#xD;
      use were developed to treat asthma, which is predominantly a disease of the large airways,&#xD;
      and these inhalers may not be optimal in treating COPD patients (which is predominantly a&#xD;
      disease of the small airways). Poor delivery of inhaled bronchodilators to the peripheral&#xD;
      deep airways may be a major factor limiting the clinical benefit provided by existing&#xD;
      devices. The key to successful treatment could be to accurately target inhaled drug to the&#xD;
      diseased lung sites, which is the hypothesis that this protocol will test.&#xD;
&#xD;
      DESIGN &amp; FUNDING:&#xD;
&#xD;
      Dr Omar Usmani has developed the research protocol and the study has been funded by the UK&#xD;
      Government Department of Health through the NIHR (National Institute for Health Research),&#xD;
      which funds leading edge research in the NHS focussed on the needs of patients and the public&#xD;
      and aims to improve the health and wealth of the nation through research. The study has been&#xD;
      peer reviewed by International Experts in this field of research.&#xD;
&#xD;
      PROTOCOL:&#xD;
&#xD;
      This protocol has two studies: Lung DEPOSITION study (in COPD patients and Healthy subjects)&#xD;
      and Lung PHYSIOLOGY study (in COPD patients and Asthmatics).&#xD;
&#xD;
      Each study (Lung DEPOSITION and Lung PHYSIOLOGY) will be a randomised, double-blind,&#xD;
      crossover, (7 treatments,controlled against pMDI salbutamol), study. Treatments will be given&#xD;
      as one off dose administration.&#xD;
&#xD;
      There will be an interval of at least 5 days between each study visit. The Lung DEPOSITION&#xD;
      study will involve radiolabelled drug treatments.&#xD;
&#xD;
      All the treatments in the LUNG PHYSIOLOGY study will be non-radiolabelled. Salbutamol will be&#xD;
      the drug aerosol administered to each subject at each visit. Subjects and investigators will&#xD;
      be blinded to the 'fine-mist' aerosol particle sizes given (at 6 treatments). The control arm&#xD;
      will be salbutamol drug aerosol delivered as a 'coarse mist' standard metered dose inhaler&#xD;
      (7th treatment visit).&#xD;
&#xD;
      RECRUITMENT/SAMPLE SIZE; The study will recruit; Lung DEPOSITION study: 12 mild-moderate COPD&#xD;
      patients, 12 healthy subjects Lung PHYSIOLOGY study: 26 mild-moderate COPD patients, 13&#xD;
      mild-moderate asthmatic patients&#xD;
&#xD;
      INCLUSION / EXCLUSION:&#xD;
&#xD;
      At the screening vist, no one will be unfairly excluded from the research, particularly as&#xD;
      COPD is a disease of older age and those over 65 should not be discriminated against. This&#xD;
      research will therefore reflect the 'real world' of COPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Actual">November 27, 2017</completion_date>
  <primary_completion_date type="Actual">November 27, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ANALYSIS OF LUNG DEPOSITION - Penetration Index</measure>
    <time_frame>5 MINUTES AFTER INHALATION OF SALBUTAMOL</time_frame>
    <description>Images of the lungs will be taken for radiolabelled salbutamol treatment. The images will be processed using computer software and the lungs divided into central airways (C - region) and peripheral airways (P -region). We will analyse the amount of radiolabelled salbutamol in each region and calculate how deep into the lungs the inhaled salbutamol has reached by using the ratio C/P which is known as the Penetration Index.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</condition>
  <condition>ASTHMA</condition>
  <condition>HEALTHY SUBJECTS</condition>
  <arm_group>
    <arm_group_label>COPD 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COPD patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Second group of COPD patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asthmatics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Asthmatics patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SALBUTAMOL</intervention_name>
    <description>In the LUNG DEPOSITION STUDY; SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS WILL BE GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER WILL ALSO BE GIVEN AS A SINGLE INHALATION.&#xD;
In the LUNG PHYSIOLOGY STUDY; SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS WILL BE GIVEN AT TWO DOSAGES OF 30 MICROGRAMS AND AGAIN AT 15 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER WILL ALSO BE GIVEN AS A SINGLE INHALATION. ALL INHALATIONS WIL BE AT SLOW INHALTION IN THIS PART OF THE STUDY.</description>
    <arm_group_label>Asthmatics</arm_group_label>
    <arm_group_label>COPD 1</arm_group_label>
    <arm_group_label>COPD 2</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
    <other_name>ALBUTEROL; VENTOLIN; SALMOL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - COPD patients, either male or female, over the age of 40 with a clinical diagnosis of&#xD;
        COPD with airflow obstruction(FEV1/FVC&lt;0.7) and post-bronchodilator FEV1&gt;50% predicted, gas&#xD;
        trapping (on lung volume testing), and decreased carbon monoxide transfer factor.&#xD;
&#xD;
        Healthy subjects will be nonsmokers(or exsmokers stopped 5 years ago), will have no&#xD;
        respiratory disease, normal spirometry and be age-matched to the COPD patients.&#xD;
&#xD;
        Asthmatic subjects, either male or female, over the age of 18 with a clinical diagnosis of&#xD;
        Asthma with airflow obstruction (FEV1/FVC&lt;0.7).&#xD;
&#xD;
        All patients should be capable of giving informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Oral corticosteroids taken within last month.&#xD;
&#xD;
          2. Current involvement (or involvement in the last 4 weeks)in clinical trials assessing&#xD;
             investigational medicinal products.&#xD;
&#xD;
          3. Previous adverse reaction to short or long acting β2 agonist.&#xD;
&#xD;
          4. Any subject with a contraindication to taking inhaled beta2-adrenoceptor agonists&#xD;
             (especially salbutamol) as listed in the British National Formulary will not be&#xD;
             entered into this study.&#xD;
&#xD;
          5. Those who have experienced an acute respiratory exacerbation requiring emergency room&#xD;
             treatment and/ or hospitalisation within four weeks of visit 1 (screening visit).&#xD;
&#xD;
          6. Pregnant or breastfeeding women.&#xD;
&#xD;
          7. Subjects unable to give Informed Consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omar S USMANI, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Brompton Hospital &amp; Imperial College London</name>
      <address>
        <city>London</city>
        <zip>SW3 6LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.nihr.ac.uk/about/Pages/default.aspx</url>
    <description>INFORMATION ON THE UK-NATIONAL INSTITUTE FOR HEALTH RESEARCH</description>
  </link>
  <reference>
    <citation>Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28.</citation>
    <PMID>16192448</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <results_first_submitted>September 27, 2019</results_first_submitted>
  <results_first_submitted_qc>May 26, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 6, 2023</results_first_posted>
  <last_update_submitted>May 26, 2022</last_update_submitted>
  <last_update_submitted_qc>May 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</keyword>
  <keyword>ASTHMA</keyword>
  <keyword>SALBUTAMOL</keyword>
  <keyword>ALBUTEROL</keyword>
  <keyword>VENTOLIN</keyword>
  <keyword>LUNG PHYSIOLOGY</keyword>
  <keyword>LUNG DEPOSITION</keyword>
  <keyword>INHALERS</keyword>
  <keyword>DRUG THERAPY</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albuterol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 20, 2011</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT01721291/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This protocol has two studies: Lung DEPOSITION study (in COPD patients and Healthy subjects) and Lung PHYSIOLOGY study (in COPD patients and Asthmatics).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>COPD- Lung DEPOSITION Study</title>
          <description>Lung DEPOSITION study COPD patients All participant received SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER GIVEN AS A SINGLE INHALATION.</description>
        </group>
        <group group_id="P2">
          <title>Healthy - Lung DEPOSITION Study</title>
          <description>Lung DEPOSITION study&#xD;
Healthy participants received:&#xD;
SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER GIVEN AS A SINGLE INHALATION.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>did not like the treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>COPD</title>
          <description>COPD patients</description>
        </group>
        <group group_id="B2">
          <title>Healthy</title>
          <description>Healthy participants</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.08" lower_limit="56" upper_limit="77"/>
                    <measurement group_id="B2" value="64.08" lower_limit="50" upper_limit="76"/>
                    <measurement group_id="B3" value="65.08" lower_limit="50" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Force experation in 1s (FEV1)</title>
          <units>litre</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.63" lower_limit="0.97" upper_limit="2.24"/>
                    <measurement group_id="B2" value="2.55" lower_limit="1.55" upper_limit="3.76"/>
                    <measurement group_id="B3" value="2.12" lower_limit="0.71" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ANALYSIS OF LUNG DEPOSITION - Penetration Index</title>
        <description>Images of the lungs will be taken for radiolabelled salbutamol treatment. The images will be processed using computer software and the lungs divided into central airways (C - region) and peripheral airways (P -region). We will analyse the amount of radiolabelled salbutamol in each region and calculate how deep into the lungs the inhaled salbutamol has reached by using the ratio C/P which is known as the Penetration Index.</description>
        <time_frame>5 MINUTES AFTER INHALATION OF SALBUTAMOL</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy_1.5um Slow</title>
            <description>Healthy participants Salbutamol 1.5um slow</description>
          </group>
          <group group_id="O2">
            <title>Healthy_1.5um Fast</title>
            <description>Healthy participants Salbutamol 1.5um fast</description>
          </group>
          <group group_id="O3">
            <title>COPD 1_1.5um Slow</title>
            <description>COPD patients Salbutamol 1.5um slow</description>
          </group>
          <group group_id="O4">
            <title>COPD1_1.5um Fast</title>
            <description>Second group of COPD patients Salbutamol 1.5um fast</description>
          </group>
          <group group_id="O5">
            <title>Healthy_3um Slow</title>
            <description>Healthy participants Salbutamol 3um slow</description>
          </group>
          <group group_id="O6">
            <title>Healthy_3um Fast</title>
            <description>Healthy participants Salbutamol 3um fast</description>
          </group>
          <group group_id="O7">
            <title>COPD_3um Slow</title>
            <description>COPD patients Salbutamol 3um slow</description>
          </group>
          <group group_id="O8">
            <title>COPD_3um Fast</title>
            <description>COPD patients Salbutamol 3um fast</description>
          </group>
          <group group_id="O9">
            <title>Healthy_6um Slow</title>
            <description>Healthy participants Salbutamol 6um slow</description>
          </group>
          <group group_id="O10">
            <title>Healthy_6um Fast</title>
            <description>Healthy participants Salbutamol 6um fast</description>
          </group>
          <group group_id="O11">
            <title>COPD_6um Slow</title>
            <description>COPD patients Salbutamol 6um slow</description>
          </group>
          <group group_id="O12">
            <title>COPD_6um Fast</title>
            <description>COPD patients Salbutamol 6um fast</description>
          </group>
        </group_list>
        <measure>
          <title>ANALYSIS OF LUNG DEPOSITION - Penetration Index</title>
          <description>Images of the lungs will be taken for radiolabelled salbutamol treatment. The images will be processed using computer software and the lungs divided into central airways (C - region) and peripheral airways (P -region). We will analyse the amount of radiolabelled salbutamol in each region and calculate how deep into the lungs the inhaled salbutamol has reached by using the ratio C/P which is known as the Penetration Index.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="12"/>
                <count group_id="O10" value="12"/>
                <count group_id="O11" value="12"/>
                <count group_id="O12" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.08"/>
                    <measurement group_id="O2" value="0.72" spread="0.12"/>
                    <measurement group_id="O3" value="0.69" spread="0.13"/>
                    <measurement group_id="O4" value="0.58" spread="0.14"/>
                    <measurement group_id="O5" value="0.75" spread="0.11"/>
                    <measurement group_id="O6" value="0.63" spread="0.15"/>
                    <measurement group_id="O7" value="0.65" spread="0.18"/>
                    <measurement group_id="O8" value="0.48" spread="0.16"/>
                    <measurement group_id="O9" value="0.51" spread="0.1"/>
                    <measurement group_id="O10" value="0.46" spread="0.04"/>
                    <measurement group_id="O11" value="0.37" spread="0.12"/>
                    <measurement group_id="O12" value="0.32" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Healthy_1.5um Slow</title>
          <description>Healthy participants received Salbutamol 1.5um slow - Lung DEPOSITION study</description>
        </group>
        <group group_id="E2">
          <title>Healthy_1.5um Fast</title>
          <description>Healthy participants received Salbutamol 1.5um fast - Lung DEPOSITION study</description>
        </group>
        <group group_id="E3">
          <title>COPD_1.5um Slow</title>
          <description>Participants with COPD received Salbutamol 1.5um slow - Lung DEPOSITION study</description>
        </group>
        <group group_id="E4">
          <title>COPD_1.5um Fast</title>
          <description>Participants with COPD received Salbutamol 1.5um fast - Lung DEPOSITION study</description>
        </group>
        <group group_id="E5">
          <title>Healthy_3um Slow</title>
          <description>Healthy participants received Salbutamol 3um slow - Lung DEPOSITION study</description>
        </group>
        <group group_id="E6">
          <title>Healthy_3um Fast</title>
          <description>Healthy participants received Salbutamol 3um fast - Lung DEPOSITION study</description>
        </group>
        <group group_id="E7">
          <title>COPD_3um Slow</title>
          <description>Participants with received COPD Salbutamol 3um slow - Lung DEPOSITION study</description>
        </group>
        <group group_id="E8">
          <title>COPD_3um Fast</title>
          <description>Participants with COPD Salbutamol 3um fast - Lung DEPOSITION study</description>
        </group>
        <group group_id="E9">
          <title>Healthy_6um Slow</title>
          <description>Healthy participants received Salbutamol 6um slow - Lung DEPOSITION study</description>
        </group>
        <group group_id="E10">
          <title>Healthy_6um Fast</title>
          <description>Healthy participants received Salbutamol 6um fast - Lung DEPOSITION study</description>
        </group>
        <group group_id="E11">
          <title>COPD_6um Slow</title>
          <description>Participants with COPD received Salbutamol 6um slow - Lung DEPOSITION study</description>
        </group>
        <group group_id="E12">
          <title>COPD_6um Fast</title>
          <description>Participants with COPD received Salbutamol 6um fast - Lung DEPOSITION study</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoe</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Chest infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pulled muscle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Flu</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cataract operatoin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Omar Usmani</name_or_title>
      <organization>Imperial College London</organization>
      <phone>+440(0) 207351 8051</phone>
      <email>o.usmani@imperial.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01721291
org study id: NIHRCDF
secondary id: NIHR-CDF-2011-04-053
secondary id: 2011-005544-10
nct id: NCT01721291
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties
      because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to
      provide relief from breathlessness. However, current inhalers are inefficient as they deliver
      a 'coarse-mist' of drug-droplets that do not reach the deep airways.

      In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive
      tracer to track them. We will take images of the lungs to see if the fine-mist droplets reach
      the deep airways, and assess if this improves the breathing capacity in our patients. Our
      research may allow the development of new, more efficient inhalers to improve treatment for
      patients with COPD.
PURPOSE:

      The purpose of the research (or "knowledge gap" this research is designed to fill) is to
      understand the fate of inhaled drug within the lungs of COPD patients. Current inhalers in
      use were developed to treat asthma, which is predominantly a disease of the large airways,
      and these inhalers may not be optimal in treating COPD patients (which is predominantly a
      disease of the small airways). Poor delivery of inhaled bronchodilators to the peripheral
      deep airways may be a major factor limiting the clinical benefit provided by existing
      devices. The key to successful treatment could be to accurately target inhaled drug to the
      diseased lung sites, which is the hypothesis that this protocol will test.

      DESIGN & FUNDING:

      Dr Omar Usmani has developed the research protocol and the study has been funded by the UK
      Government Department of Health through the NIHR (National Institute for Health Research),
      which funds leading edge research in the NHS focussed on the needs of patients and the public
      and aims to improve the health and wealth of the nation through research. The study has been
      peer reviewed by International Experts in this field of research.

      PROTOCOL:

      This protocol has two studies: Lung DEPOSITION study (in COPD patients and Healthy subjects)
      and Lung PHYSIOLOGY study (in COPD patients and Asthmatics).

      Each study (Lung DEPOSITION and Lung PHYSIOLOGY) will be a randomised, double-blind,
      crossover, (7 treatments,controlled against pMDI salbutamol), study. Treatments will be given
      as one off dose administration.

      There will be an interval of at least 5 days between each study visit. The Lung DEPOSITION
      study will involve radiolabelled drug treatments.

      All the treatments in the LUNG PHYSIOLOGY study will be non-radiolabelled. Salbutamol will be
      the drug aerosol administered to each subject at each visit. Subjects and investigators will
      be blinded to the 'fine-mist' aerosol particle sizes given (at 6 treatments). The control arm
      will be salbutamol drug aerosol delivered as a 'coarse mist' standard metered dose inhaler
      (7th treatment visit).

      RECRUITMENT/SAMPLE SIZE; The study will recruit; Lung DEPOSITION study: 12 mild-moderate COPD
      patients, 12 healthy subjects Lung PHYSIOLOGY study: 26 mild-moderate COPD patients, 13
      mild-moderate asthmatic patients

      INCLUSION / EXCLUSION:

      At the screening vist, no one will be unfairly excluded from the research, particularly as
      COPD is a disease of older age and those over 65 should not be discriminated against. This
      research will therefore reflect the 'real world' of COPD.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: ANALYSIS OF LUNG DEPOSITION - Penetration Index
time frame: 5 MINUTES AFTER INHALATION OF SALBUTAMOL
description: Images of the lungs will be taken for radiolabelled salbutamol treatment. The images will be processed using computer software and the lungs divided into central airways (C - region) and peripheral airways (P -region). We will analyse the amount of radiolabelled salbutamol in each region and calculate how deep into the lungs the inhaled salbutamol has reached by using the ratio C/P which is known as the Penetration Index.
arm group label: COPD 1
arm group type: Experimental
description: COPD patients
arm group label: Healthy
arm group type: Experimental
description: Healthy participants
arm group label: COPD 2
arm group type: Experimental
description: Second group of COPD patients
arm group label: Asthmatics
arm group type: Active Comparator
description: Asthmatics patients
intervention type: Drug
intervention name: SALBUTAMOL
description: In the LUNG DEPOSITION STUDY; SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS WILL BE GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER WILL ALSO BE GIVEN AS A SINGLE INHALATION.
In the LUNG PHYSIOLOGY STUDY; SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS WILL BE GIVEN AT TWO DOSAGES OF 30 MICROGRAMS AND AGAIN AT 15 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER WILL ALSO BE GIVEN AS A SINGLE INHALATION. ALL INHALATIONS WIL BE AT SLOW INHALTION IN THIS PART OF THE STUDY.
arm group label: Asthmatics
arm group label: COPD 1
arm group label: COPD 2
arm group label: Healthy
other name: ALBUTEROL; VENTOLIN; SALMOL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Omar S USMANI, MD, PhD
role: Principal Investigator
affiliation: Imperial College London
facility: 
country: United Kingdom
url: http://www.nihr.ac.uk/about/Pages/default.aspx
description: INFORMATION ON THE UK-NATIONAL INSTITUTE FOR HEALTH RESEARCH
citation: Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28.
PMID: 16192448
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Albuterol
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 