Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04999930

Enrollment

100

Registered

2021-08-11

Start date

2020-01-10

Completion date

2021-02-28

Last updated

2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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

Interventions

DEVICEAerochamber

efficacy and patients satisfaction

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 quality of life (SGRQ questionaire)	18 weeks	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	18 weeks	Scale of 0-5, (0-very easy, 5-hard)

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026