Exacerbation CopdPhase 3NCT04122547
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis
A Phase 3 study testing Roflumilast in people with Exacerbation Copd and Bronchiectasis, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Exacerbation Copd, Bronchiectasis, Lung Function Decreased
- What is being tested?
- Roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic Bronchiectasis
- history at least 2 exacerbation last year
Who cannot join
- comorbidity with chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial
Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis
Read the detailed description
Efficacy and RCT compare roflumilast vs placebo for 6 months in frequent infectious exacerbation in non-cystic bronchiectasis in Thailand
- Conditions
- Exacerbation Copd, Bronchiectasis, Lung Function Decreased
- Being tested
- Roflumilast, Placebo
- Keywords
- Bronchiectasis, roflumilast, exacerbation, lung function
- Medical subject headings
- Bronchiectasis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
Also called Daxas
Active drug
PlaceboDrug
Placebo one tablet oral od
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast | Active comparator | Roflumilast 500 microgram one tab oral per day Receives: Drug: Roflumilast |
| Placebo | Placebo comparator | One tablet oral per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute deterioration of of bronchiectasis symptoms
acute dyspnea worsening respiratory of symptoms
Measured: 6 months
Secondary outcomes (2)
Lung functions
FEV1
Measured: 6 months
Exercise capacity
6 minute walk distance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exacerbation CopdStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siwasak Juthong, Prince of Songkla University
- Investigators
- Kanung Saejiam, MS, Study director, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122547
- Sponsor's protocol ID
- 25132558
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04122547
- Acronym / sponsor ID
- 25132558
- Conditions
- Exacerbation Copd, Bronchiectasis, Lung Function Decreased
- Keywords
- Bronchiectasis, roflumilast, exacerbation, lung function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Oct 2019 (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.
Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis
Detailed description
Efficacy and RCT compare roflumilast vs placebo for 6 months in frequent infectious exacerbation in non-cystic bronchiectasis in Thailand
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast | Active comparator | Drug: RoflumilastRoflumilast 500 microgram one tab oral per day |
| Placebo | Placebo comparator | Drug: PlaceboOne tablet oral per day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic Bronchiectasis
- history at least 2 exacerbation last year
Key exclusion criteria (1 listed)
- comorbidity with chronic obstructive pulmonary disease
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 |
|---|---|---|
| RoflumilastAlso: DaxasActive drug | Drug | Roflumilast |
| PlaceboPlacebo one tablet oral od | Drug | Placebo |
Primary outcome
acute deterioration of of bronchiectasis symptoms
Time frame: 6 months
acute dyspnea worsening respiratory of symptoms
2 secondary outcomes
Lung functions
Time frame: 6 months
Exercise capacity
Time frame: 6 months
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 10 Oct 2019.
- 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.
Kanung Saejiam, MS study director
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roflumilast in people with Exacerbation Copd and Bronchiectasis, run by Prince of Songkla University at 1 site in Thailand.
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 2 inclusion and 1 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 10 Oct 2019. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
acute deterioration of of bronchiectasis symptoms (time frame: 6 months). 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 10 Oct 2019.