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)
1 other identifier
interventional
100
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedFirst Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedAugust 18, 2021
August 1, 2021
1.1 years
June 18, 2021
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change of FEV1 (%) between the treatment group
18 weeks
Types of inhaler technique error between the group
18 weeks
To assess quality of life (SGRQ questionaire)
18 weeks
To assess patients satisfaction and preference, attitudes, and perceptions about their inhalers using questionnaire
18 weeks
Study Arms (2)
Group A
EXPERIMENTALwith aerochamber
Group B
EXPERIMENTALwithout aerochamber
Interventions
efficacy and patients satisfaction
Eligibility Criteria
You may qualify if:
- 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
- Patient able to perform inhaler medication
- Patient able to perform technically acceptable pulmonary function test
You may not qualify if:
- Drug hypersensitivity
- Bronchial Asthma
- Significant disease that may influence patient's ability to participate in the study.
- Unable to provide signed informed consent
- Mental condition rendering the subject unable to understand the nature, scope and the possible consequences of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University of Malaysia
Cheras, Kuala Lumpur, 50600, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Doctor
Study Record Dates
First Submitted
June 18, 2021
First Posted
August 11, 2021
Study Start
January 10, 2020
Primary Completion
February 28, 2021
Study Completion
February 28, 2021
Last Updated
August 18, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share