Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison of Clinical Efficacy and Patient's Satisfaction of Tiotropium Respimat Administration With and Without Aerochamber in Patient With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Aerochamber


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>with aerochamber | Device: Aerochamber<br>* efficacy and patients satisfaction<br>* Other names: Tiotropium respimart;|
| Experimental: Group B<br>without aerochamber | Device: Aerochamber<br>* efficacy and patients satisfaction<br>* Other names: Tiotropium respimart;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of FEV1 (%) between the treatment group | Comparing differences of lung function (FEV1 %) in both groups after cross-over | 18 weeks | 
| Types of inhaler technique error between the group | Comparing inhaler errors in both groups based on the checklist | 18 weeks | 
| To assess quality of life (SGRQ questionaire) | Scores range from 0 to 100, with higher scores indicating more limitations. | 18 weeks | 
| To assess patients satisfaction and preference, attitudes, and perceptions about their inhalers using questionnaire | Scale of 0-5, (0-very easy, 5-hard) | 18 weeks |