Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)

National University of Malaysia

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Aerochamber

Study type: Interventional

Funder types: Other

Identifiers

NCT04999930

FF-2019-462

Details and patient eligibility

About

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 .

Full 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

Enrollment: 100 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A

Experimental group

Description:

with aerochamber

Treatment:

Device: Aerochamber

Group B

Experimental group

Description:

without aerochamber

Treatment:

Device: Aerochamber