<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/NCT03275935</url>
  </required_header>
  <id_info>
    <org_study_id>73/17</org_study_id>
    <nct_id>NCT03275935</nct_id>
  </id_info>
  <brief_title>Evaluation of Inhalation Technique in Patients With COPD, Asthma or ACOS Using a Dry Powder Device (DPI)</brief_title>
  <official_title>Evaluation of Inhalation Technique in Patients With Chronic Obstructive Pulmonary Disease (COPD), Asthma or Asthma-COPD Overlap Syndrome(ACOS) Using a Dry Powder Device at Chest Clinic in Dhulikhel Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kathmandu University School of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kathmandu University School of Medical Sciences</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study analyzes the prevalence of patients using inhalation devices via incorrect&#xD;
      technique and access the adherence of patients to correct inhalation technique when taught&#xD;
      along with their subjective improvement of symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a one group pretest- posttest design conducted in all patients presenting in Chest&#xD;
      clinic of Dhulikhel Hospital-Kathmandu University Hospital, Nepal from March 2017 to May&#xD;
      2017. Patients diagnosed of having COPD, Asthma or Asthma-COPD Overlap Syndrome (ACOS) and&#xD;
      were under inhalation bronchodilators in the form of Dry Powder Device via Rotahaler were&#xD;
      included. Enrolled patients are assessed for inhalation technique compliance at their routine&#xD;
      medical (pre-training) visits by physician. The use of inhaler device is evaluated in a&#xD;
      practical manner by asking the patients to demonstrate their inhalation technique. After the&#xD;
      assessment, instructions and training are given until they can use the device correctly. One&#xD;
      month later (post-training), all patients are re-evaluated in regards to inhalation technique&#xD;
      and subjective improvement of symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Change in 'Inhalation Scores&quot; After a month from Baseline</measure>
    <time_frame>After a month</time_frame>
    <description>An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7. After assessment, instructions were given with demonstrations regarding the correct use of Rotahaler. One month later (post-training visit), all patients were re-evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalance COPD, Asthma and Asthma COPD Overlap Syndrome inpatients visiting Chest Clinic of Dhulikhel Hospital- Kathmandu University Hospital.</measure>
    <time_frame>3 months</time_frame>
    <description>Calculating the prevalence of the three medical conditions in Chest clinic of Dhulikhel Hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associated Factors for Incorrect Inhalation Technique</measure>
    <time_frame>3 months</time_frame>
    <description>The potential associated factors for an incorrect inhalation technique to be calculated via univariable logistic regression analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of patients using the inhalation devices via incorrect technique</measure>
    <time_frame>At pretraining</time_frame>
    <description>An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">307</enrollment>
  <condition>COPD Asthma</condition>
  <condition>Asthma-COPD Overlap Syndrome</condition>
  <condition>Inhalation</condition>
  <arm_group>
    <arm_group_label>Training Arm</arm_group_label>
    <description>Patients that were given training in regards to proper inhalation technique of Rotahalers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients presenting to Chest Clinic of Dhulikhel hospital, who were diagnosed of having&#xD;
        either COPD, Asthma or Asthma-COPD Overlap Syndrome and are currently under inhalational&#xD;
        bronchodilators in the form of Dry Powder Device (DPIs)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years,&#xD;
&#xD;
          -  Diagnosed of having of asthma or COPD or ACOS&#xD;
&#xD;
          -  Using dry powder inhaler therapy with Rotahaler&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of inhaler devices other than Rotahaler&#xD;
&#xD;
          -  Newly started on dry powdered inhalational therapy or patients who had recently&#xD;
             received face-to-face training program on inhalation technique within the past one&#xD;
             month&#xD;
&#xD;
          -  Patients in acute exacerbation&#xD;
&#xD;
          -  Patients failing to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Sudeep Shrestha, MD, MRCP(UK)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dhulikhel Hospital- Kathmandu University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dhulikhel Hospital- Kathmandu University Hospital</name>
      <address>
        <city>Dhulikhel</city>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kathmandu University School of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Dr Sudeep Shrestha</investigator_full_name>
    <investigator_title>Lecturer, CardioPulmonology Unit, Department of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>ACOS</keyword>
  <keyword>Asthma</keyword>
  <keyword>COPD</keyword>
  <keyword>inhalation technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03275935
org study id: 73/17
nct id: NCT03275935
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study analyzes the prevalence of patients using inhalation devices via incorrect
      technique and access the adherence of patients to correct inhalation technique when taught
      along with their subjective improvement of symptoms.
This is a one group pretest- posttest design conducted in all patients presenting in Chest
      clinic of Dhulikhel Hospital-Kathmandu University Hospital, Nepal from March 2017 to May
      2017. Patients diagnosed of having COPD, Asthma or Asthma-COPD Overlap Syndrome (ACOS) and
      were under inhalation bronchodilators in the form of Dry Powder Device via Rotahaler were
      included. Enrolled patients are assessed for inhalation technique compliance at their routine
      medical (pre-training) visits by physician. The use of inhaler device is evaluated in a
      practical manner by asking the patients to demonstrate their inhalation technique. After the
      assessment, instructions and training are given until they can use the device correctly. One
      month later (post-training), all patients are re-evaluated in regards to inhalation technique
      and subjective improvement of symptoms.
observational model: Cohort
time perspective: Prospective
measure: Change in 'Inhalation Scores" After a month from Baseline
time frame: After a month
description: An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7. After assessment, instructions were given with demonstrations regarding the correct use of Rotahaler. One month later (post-training visit), all patients were re-evaluated
measure: Prevalance COPD, Asthma and Asthma COPD Overlap Syndrome inpatients visiting Chest Clinic of Dhulikhel Hospital- Kathmandu University Hospital.
time frame: 3 months
description: Calculating the prevalence of the three medical conditions in Chest clinic of Dhulikhel Hospital
measure: Associated Factors for Incorrect Inhalation Technique
time frame: 3 months
description: The potential associated factors for an incorrect inhalation technique to be calculated via univariable logistic regression analysis
measure: Prevalence of patients using the inhalation devices via incorrect technique
time frame: At pretraining
description: An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7.
arm group label: Training Arm
description: Patients that were given training in regards to proper inhalation technique of Rotahalers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Sudeep Shrestha, MD, MRCP(UK)
role: Principal Investigator
affiliation: Dhulikhel Hospital- Kathmandu University Hospital
facility: 
country: Nepal
responsible party type: Principal Investigator
investigator affiliation: Kathmandu University School of Medical Sciences
investigator full name: Dr Sudeep Shrestha
investigator title: Lecturer, CardioPulmonology Unit, Department of Internal Medicine
mesh term: Asthma
mesh term: Respiratory Aspiration
mesh term: Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
mesh term: Syndrome
sharing ipd: Undecided