Chronic Obstructive Pulmonary DiseaseNCT04999930
Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)
A study testing Aerochamber in people with Chronic Obstructive Pulmonary Disease, run by National University of Malaysia at 1 site in Malaysia.
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 . Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Aerochamber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Jan 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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 .
Read the detailed description
- COPD patient who is on Tiotropium Respimart and other inhalers continued.
- Those fullfill inclusion criteria will be randomized into two group.
- To do Baseline CAT score and SGRQ questionnaires with Lung function test.
- Assess inhaler technique with and without aerochamber.
- Teach proper inhaler technique by templates and demonstrate to patients.
- Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .
- First phase for 8 week after that 2 week of washout periode (without aerochamber both arm).
- Then Group A without aerochamber and Group B with aerochamber continue with all inhalers for 8 week.
- Followed up at 8th , 11th and 18th week to assess inhaler techniques ,Lung function test and do CAT score, and SGRQ questionnaire.
- Analysis data
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Aerochamber
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AerochamberDevice
Also called Tiotropium respimart
efficacy and patients satisfaction
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | with aerochamber Receives: Device: Aerochamber |
| Group B | Experimental | without aerochamber Receives: Device: Aerochamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 weeks
Secondary outcomes (4)
Change of FEV1 (%) between the treatment group
Comparing differences of lung function (FEV1 %) in both groups after cross-over
Measured: 18 weeks
Types of inhaler technique error between the group
Comparing inhaler errors in both groups based on the checklist
Measured: 18 weeks
To assess quality of life (SGRQ questionaire)
Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 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)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start10 Jan 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Faisal Abdul Hamid, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999930
- Sponsor's protocol ID
- FF-2019-462
- Status last verified
- Aug 2021
- First submitted
- 18 Jun 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04999930
- Acronym / sponsor ID
- FF-2019-462
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- COPD patient who is on Tiotropium Respimart and other inhalers continued.
- Those fullfill inclusion criteria will be randomized into two group.
- To do Baseline CAT score and SGRQ questionnaires with Lung function test.
- Assess inhaler technique with and without aerochamber.
- Teach proper inhaler technique by templates and demonstrate to patients.
- Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .
- First phase for 8 week after that 2 week of washout periode (without aerochamber both arm).
- Then Group A without aerochamber and Group B with aerochamber continue with all inhalers for 8 week.
- Followed up at 8th , 11th and 18th week to assess inhaler techniques ,Lung function test and do CAT score, and SGRQ questionnaire.
- Analysis data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Aerochamberwith aerochamber |
| Group B | Experimental | Device: Aerochamberwithout aerochamber |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD patients under Respiratory clinic UKM follow up
- Patient able to perform inhaler medication
- Patient able to perform technically acceptable pulmonary function test
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AerochamberAlso: Tiotropium respimartefficacy and patients satisfaction | Device | Group A, Group B |
Primary outcome
To compare the frequency of exacerbation (number of events ) and hospital admission (number of admissions) using tiotropium with and without aerochamber
Time frame: 18 weeks
Comparing frequency of exacerbation (number of events ) and hospital admission (number of admissions) in both groups
4 secondary outcomes
Change of FEV1 (%) between the treatment group
Time frame: 18 weeks
Types of inhaler technique error between the group
Time frame: 18 weeks
To assess quality of life (SGRQ questionaire)
Time frame: 18 weeks
To assess patients satisfaction and preference, attitudes, and perceptions about their inhalers using questionnaire
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerochamber in people with Chronic Obstructive Pulmonary Disease, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the frequency of exacerbation (number of events ) and hospital admission (number of admissions) using tiotropium with and without aerochamber (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.