Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04999930
• Other study ID #: FF-2019-462
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2021
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Aerochamber
efficacy and patients satisfaction

Locations

Country	Name	City	State
Malaysia	National University of Malaysia	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of FEV1 (%) between the treatment group	Comparing differences of lung function (FEV1 %) in both groups after cross-over	18 weeks
Secondary	Types of inhaler technique error between the group	Comparing inhaler errors in both groups based on the checklist	18 weeks
Secondary	To assess quality of life (SGRQ questionaire)	Scores range from 0 to 100, with higher scores indicating more limitations.	18 weeks
Secondary	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