<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/NCT01677403</url>
  </required_header>
  <id_info>
    <org_study_id>qlhqiqian</org_study_id>
    <secondary_id>QL</secondary_id>
    <nct_id>NCT01677403</nct_id>
  </id_info>
  <brief_title>A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis</brief_title>
  <official_title>A Randomized,Controlled Study to Evaluate the Efficacy,Indications,Adverse Reactions and Resistance of Combined Administration of Nebulized Tobramycin Compared With Systemic Administration Alone in Patients With Bronchiectasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to evaluate the efficacy,indications,adverse reactions and resistance of&#xD;
      combined administration of nebulized tobramycin compared with systemic administration alone&#xD;
      in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by&#xD;
      permanent dilation, microbial infection, a persistent inflammatory response with the release&#xD;
      of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis&#xD;
      varies, but the presence of microbial infection and a persistent inflammatory response is&#xD;
      typical of the disease. The chronic nature of the infection and the associated considerable&#xD;
      morbidity provides the rationale for using aerosolized antibiotics for the treatment of&#xD;
      bronchiectasis patients.&#xD;
&#xD;
      This is a study of safety and efficacy of combined administration of nebulized tobramycin&#xD;
      compared with systemic administration alone in patients with Bronchiectasis in acute&#xD;
      exacerbation of Bronchiectasis. Study subjects will be randomized to receive either study&#xD;
      drug or placebo by inhalation via a nebulizer. Each subject will complete 14 days of daily&#xD;
      dosing.&#xD;
&#xD;
      Clinical laboratory parameters,clinical adverse events and pulmonary function will be&#xD;
      evaluated for all study subjects in order to determine the qualitative and quantitative&#xD;
      safety and efficacy of nebulized tobramycin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate change in density of Pseudomonas aeruginosa in sputum</measure>
    <time_frame>days 1,7,14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate chang in the amount of sputum</measure>
    <time_frame>days 1,7,14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate chang in patients' cough severity</measure>
    <time_frame>days 1,7,14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate change in pulmonary function</measure>
    <time_frame>days 1,7,14</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Bronchiectasis</condition>
  <arm_group>
    <arm_group_label>Nebulised Tobramycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nebulised Tobramycin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nebulised 0.9% Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Nebulised 0.9% Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tobramycin</intervention_name>
    <description>Nebulised 80mg twice daily</description>
    <arm_group_label>Nebulised Tobramycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Nebulised 5mls 0.9% Saline twice daily</description>
    <arm_group_label>Nebulised 0.9% Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female study subjects ≥18 years of age and ≤80 years of age&#xD;
&#xD;
          2. Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis&#xD;
&#xD;
          3. Confirmation of infection with P. aeruginosa at screening&#xD;
&#xD;
          4. Are sensitive to Tobramycin&#xD;
&#xD;
          5. Acute exacerbation of bronchiectasis -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Bronchiectasis due to special causes.&#xD;
&#xD;
          2. Smokers.&#xD;
&#xD;
          3. Are associated with bronchial asthma.&#xD;
&#xD;
          4. Have any serious or active medical or psychiatric illness.&#xD;
&#xD;
          5. Are not tolerant to nebulised tobramycin&#xD;
&#xD;
          6. FEV1.0 reduces ≥ 15% after inhaling tobramycin. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Qi</last_name>
    <email>xiaokangqlh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250100</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>August 26, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>December 4, 2012</last_update_submitted>
  <last_update_submitted_qc>December 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Qi Qian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Bronchiectasis</keyword>
  <keyword>Tobramycin</keyword>
  <keyword>nebulised</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiectasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobramycin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01677403
org study id: qlhqiqian
secondary id: QL
nct id: NCT01677403
lead sponsor: 
has dmc: No
This is a study to evaluate the efficacy,indications,adverse reactions and resistance of
      combined administration of nebulized tobramycin compared with systemic administration alone
      in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.
Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by
      permanent dilation, microbial infection, a persistent inflammatory response with the release
      of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis
      varies, but the presence of microbial infection and a persistent inflammatory response is
      typical of the disease. The chronic nature of the infection and the associated considerable
      morbidity provides the rationale for using aerosolized antibiotics for the treatment of
      bronchiectasis patients.

      This is a study of safety and efficacy of combined administration of nebulized tobramycin
      compared with systemic administration alone in patients with Bronchiectasis in acute
      exacerbation of Bronchiectasis. Study subjects will be randomized to receive either study
      drug or placebo by inhalation via a nebulizer. Each subject will complete 14 days of daily
      dosing.

      Clinical laboratory parameters,clinical adverse events and pulmonary function will be
      evaluated for all study subjects in order to determine the qualitative and quantitative
      safety and efficacy of nebulized tobramycin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate change in density of Pseudomonas aeruginosa in sputum
time frame: days 1,7,14
measure: To evaluate chang in the amount of sputum
time frame: days 1,7,14
measure: To evaluate chang in patients' cough severity
time frame: days 1,7,14
measure: To evaluate change in pulmonary function
time frame: days 1,7,14
arm group label: Nebulised Tobramycin
arm group type: Active Comparator
description: Nebulised Tobramycin
arm group label: Nebulised 0.9% Saline
arm group type: Placebo Comparator
description: Nebulised 0.9% Saline
intervention type: Drug
intervention name: Tobramycin
description: Nebulised 80mg twice daily
arm group label: Nebulised Tobramycin
intervention type: Drug
intervention name: Saline
description: Nebulised 5mls 0.9% Saline twice daily
arm group label: Nebulised 0.9% Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Qi
email: xiaokangqlh@163.com
facility: 
status: Recruiting
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Qi Qian
investigator title: Principal Investigator
mesh term: Bronchiectasis
mesh term: Tobramycin