Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Aerochamber
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
COPD patients under Respiratory clinic UKM follow up
- Patients who are with stable COPD (no exacerbation past 2 months)
- Age same and more than 40-year-old
- Patient able to perform inhaler medication
- Patient able to perform technically acceptable pulmonary function test
Exclusion Criteria:
- Drug hypersensitivity
- Bronchial Asthma
- Significant disease that may influence patient's ability to participate in the study.
- Unable to provide signed informed consent
- Mental condition rendering the subject unable to understand the nature, scope and the possible consequences of the study.
Sites / Locations
- National University of Malaysia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
with aerochamber
without aerochamber
Outcomes
Primary Outcome Measures
To compare the frequency of exacerbation (number of events ) and hospital admission (number of admissions) using tiotropium with and without aerochamber
Comparing frequency of exacerbation (number of events ) and hospital admission (number of admissions) in both groups
Secondary Outcome Measures
Change of FEV1 (%) between the treatment group
Comparing differences of lung function (FEV1 %) in both groups after cross-over
Types of inhaler technique error between the group
Comparing inhaler errors in both groups based on the checklist
To assess quality of life (SGRQ questionaire)
Scores range from 0 to 100, with higher scores indicating more limitations.
To assess patients satisfaction and preference, attitudes, and perceptions about their inhalers using questionnaire
Scale of 0-5, (0-very easy, 5-hard)
Full Information
NCT ID
NCT04999930
First Posted
June 18, 2021
Last Updated
August 11, 2021
Sponsor
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT04999930
Brief Title
Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)
Official Title
Comparison of Clinical Efficacy and Patient's Satisfaction of Tiotropium Respimat Administration With and Without Aerochamber in Patient With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
COPD patient on Tiotropium Respimart divided into two group, Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .
Detailed Description
COPD patient who is on Tiotropium Respimart and other inhalers continued.
Those fullfill inclusion criteria will be randomized into two group.
To do Baseline CAT score and SGRQ questionnaires with Lung function test.
Assess inhaler technique with and without aerochamber.
Teach proper inhaler technique by templates and demonstrate to patients.
Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .
First phase for 8 week after that 2 week of washout periode (without aerochamber both arm).
Then Group A without aerochamber and Group B with aerochamber continue with all inhalers for 8 week.
Followed up at 8th , 11th and 18th week to assess inhaler techniques ,Lung function test and do CAT score, and SGRQ questionnaire.
Analysis data
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
with aerochamber
Arm Title
Group B
Arm Type
Experimental
Arm Description
without aerochamber
Intervention Type
Device
Intervention Name(s)
Aerochamber
Other Intervention Name(s)
Tiotropium respimart
Intervention Description
efficacy and patients satisfaction
Primary Outcome Measure Information:
Title
To compare the frequency of exacerbation (number of events ) and hospital admission (number of admissions) using tiotropium with and without aerochamber
Description
Comparing frequency of exacerbation (number of events ) and hospital admission (number of admissions) in both groups
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Change of FEV1 (%) between the treatment group
Description
Comparing differences of lung function (FEV1 %) in both groups after cross-over
Time Frame
18 weeks
Title
Types of inhaler technique error between the group
Description
Comparing inhaler errors in both groups based on the checklist
Time Frame
18 weeks
Title
To assess quality of life (SGRQ questionaire)
Description
Scores range from 0 to 100, with higher scores indicating more limitations.
Time Frame
18 weeks
Title
To assess patients satisfaction and preference, attitudes, and perceptions about their inhalers using questionnaire
Description
Scale of 0-5, (0-very easy, 5-hard)
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
COPD patients under Respiratory clinic UKM follow up
Patients who are with stable COPD (no exacerbation past 2 months)
Age same and more than 40-year-old
Patient able to perform inhaler medication
Patient able to perform technically acceptable pulmonary function test
Exclusion Criteria:
Drug hypersensitivity
Bronchial Asthma
Significant disease that may influence patient's ability to participate in the study.
Unable to provide signed informed consent
Mental condition rendering the subject unable to understand the nature, scope and the possible consequences of the study.
Facility Information:
Facility Name
National University of Malaysia
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
50600
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
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Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)
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