Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Aerochamber

• Registration Number: NCT04999930
• Lead Sponsor: National University of Malaysia

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

1. COPD patient who is on Tiotropium Respimart and other inhalers continued.

2. Those fullfill inclusion criteria will be randomized into two group.

3. To do Baseline CAT score and SGRQ questionnaires with Lung function test.

4. Assess inhaler technique with and without aerochamber.

5. Teach proper inhaler technique by templates and demonstrate to patients.

6. Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .

7. First phase for 8 week after that 2 week of washout periode (without aerochamber both arm).

8. Then Group A without aerochamber and Group B with aerochamber continue with all inhalers for 8 week.

9. Followed up at 8th , 11th and 18th week to assess inhaler techniques ,Lung function test and do CAT score, and SGRQ questionnaire.

10. Analysis data

Study Timeline

• Study Start: 2020-01-10
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Study First Submitted: 2021-06-18
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-11
• Last Update Submitted: 2021-08-11
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 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

2. Patient able to perform inhaler medication

3. Patient able to perform technically acceptable pulmonary function test

Exclusion Criteria

1. Drug hypersensitivity
2. Bronchial Asthma
3. Significant disease that may influence patient's ability to participate in the study.
4. Unable to provide signed informed consent
5. Mental condition rendering the subject unable to understand the nature, scope and the possible consequences of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Aerochamber	without aerochamber
Group A	Aerochamber	with aerochamber

Primary Outcome Measures

Name	Time	Method
To compare the frequency of exacerbation (number of events ) and hospital admission (number of admissions) using tiotropium with and without aerochamber	18 weeks	Comparing frequency of exacerbation (number of events ) and hospital admission (number of admissions) in both groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National University of Malaysia; 🇲🇾 Cheras, Kuala Lumpur, Malaysia