Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)

National University of Malaysia100 enrolled

Overview

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 .

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

AerochamberDEVICE

efficacy and patients satisfaction

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

National University of Malaysia

Cheras, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

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

Time frame: 18 weeks

Secondary Outcomes

Change of FEV1 (%) between the treatment group

Comparing differences of lung function (FEV1 %) in both groups after cross-over

Time frame: 18 weeks

Types of inhaler technique error between the group

Comparing inhaler errors in both groups based on the checklist

Time frame: 18 weeks

To assess quality of life (SGRQ questionaire)

Scores range from 0 to 100, with higher scores indicating more limitations.

Time frame: 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)

Time frame: 18 weeks

Data from ClinicalTrials.gov

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