Chronic Obstructive Pulmonary DiseasePhase 2/3NCT02195375
Flutiform® Compared With Seretide® in the Treatment of COPD
A Phase 2/3 study testing Flutiform 500/20 µg BID, Flutiform 250/10 µg BID and Seretide Accuhaler 50/500 µg BID in people with Chronic Obstructive Pulmonary Disease, run by Mundipharma Research Limited at 5 sites in 5 countries.
Trial summary
The purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Flutiform 500/20 µg BID, Flutiform 250/10 µg BID and Seretide Accuhaler 50/500 µg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 923 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Sep 2014to May 2016
- Phase
- Phase 2/3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female subjects aged ≥ 40 years at screening visit.
- Diagnosis of COPD
- Willing and able to replace current COPD therapy with study medication.
- Able to demonstrate correct use of a pMDI with or without a spacer and Accuhaler.
- Willing and able to attend all study visits and complete study assessments.
- Able to provide signed informed consent.
Who cannot join
- Ongoing moderate or severe exacerbation of COPD in the 2 weeks before screening.
- Current diagnosis of asthma.
- Documented evidence of α1-antitrypsin deficiency as the underlying cause of COPD.
- Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
- Previous lung resection.
- Use of long-term oxygen therapy (LTOT) or mechanical ventilation. Note: LTOT is defined as >15 hours use per day
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- Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities not believed to be due to COPD.
- Evidence of uncontrolled cardiovascular disease.
- Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease.
- Current malignancy or a previous history of cancer which has been in remission for < 5 years (basal cell or squamous cell carcinoma of the skin which has been resected is not excluded).
- Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
- Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study.
- Known or suspected history of drug or alcohol abuse in the last 2 years.
- Requiring treatment with any of the prohibited concomitant medications.
- Known or suspected hypersensitivity to study drug or excipients.
- Received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: A Randomised Double-blind, Double-dummy Parallel Group Study to Compare the Efficacy and Safety of Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 500/20 µg BID and 250/10 µg BID Versus Salmeterol / Fluticasone (Seretide®) 50/500 µg BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (COPD).
Read the detailed description
A multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group study in male and female subjects conducted to assess the efficacy and safety of flutiform in the treatment of COPD. Subjects will be randomised to one of three treatment groups in a 1:1:1 ratio. Throughout the study subjects will be assessed on a mixture of symptom based and lung function measurements to monitor their progress in the study.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Flutiform 500/20 µg BID, Flutiform 250/10 µg BID, Seretide Accuhaler 50/500 µg BID
- Keywords
- Chronic Obstructive Pulmonary Disease, FEV1 ≤ 50%
- 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.
Flutiform 500/20 µg BIDDrug
Flutiform 250/10 µg BIDDrug
Seretide Accuhaler 50/500 µg BIDDrug
| Study group | Role | What they receive |
|---|---|---|
| Flutiform 500/20 µg BID | Experimental | Flutiform 250/10 (2 puffs BID) Receives: Drug: Flutiform 500/20 µg BID |
| Flutiform 250/10 µg BID | Experimental | Flutiform 125/5 (2 puffs BID) Receives: Drug: Flutiform 250/10 µg BID |
| Seretide Accuhaler 50/500 µg BID | Active comparator | Seretide Accuhaler 50/500 (BID) Receives: Drug: Seretide Accuhaler 50/500 µg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pre-dose FEV1
Measured: 26 weeks
Secondary outcomes (1)
Average 1 hour Post dose FEV1, FVC, FEV6
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 923 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195375
- Sponsor's protocol ID
- FLT3510
- Status last verified
- Mar 2017
- First submitted
- 16 Jul 2014
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind, Double-dummy Parallel Group Study to Compare the Efficacy and Safety of Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 500/20 µg BID and 250/10 µg BID Versus Salmeterol / Fluticasone (Seretide®) 50/500 µg BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02195375
- Acronym / sponsor ID
- FLT3510
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, FEV1 ≤ 50%
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 923 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Jul 2014 (estimated)
- 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.
The purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (COPD).
Detailed description
A multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group study in male and female subjects conducted to assess the efficacy and safety of flutiform in the treatment of COPD. Subjects will be randomised to one of three treatment groups in a 1:1:1 ratio. Throughout the study subjects will be assessed on a mixture of symptom based and lung function measurements to monitor their progress in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flutiform 500/20 µg BID | Experimental | Drug: Flutiform 500/20 µg BIDFlutiform 250/10 (2 puffs BID) |
| Flutiform 250/10 µg BID | Experimental | Drug: Flutiform 250/10 µg BIDFlutiform 125/5 (2 puffs BID) |
| Seretide Accuhaler 50/500 µg BID | Active comparator | Drug: Seretide Accuhaler 50/500 µg BIDSeretide Accuhaler 50/500 (BID) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female subjects aged ≥ 40 years at screening visit.
- Diagnosis of COPD
- Willing and able to replace current COPD therapy with study medication.
- Able to demonstrate correct use of a pMDI with or without a spacer and Accuhaler.
- Willing and able to attend all study visits and complete study assessments.
Key exclusion criteria (16 listed)
- Ongoing moderate or severe exacerbation of COPD in the 2 weeks before screening.
- Current diagnosis of asthma.
- Documented evidence of α1-antitrypsin deficiency as the underlying cause of COPD.
- Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
- Previous lung resection.
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 |
|---|---|---|
| Flutiform 500/20 µg BID | Drug | Flutiform 500/20 µg BID |
| Flutiform 250/10 µg BID | Drug | Flutiform 250/10 µg BID |
| Seretide Accuhaler 50/500 µg BID | Drug | Seretide Accuhaler 50/500 µg BID |
Primary outcome
Average pre-dose FEV1
Time frame: 26 weeks
1 secondary outcome
Average 1 hour Post dose FEV1, FVC, FEV6
Time frame: 26 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 28 Mar 2017.
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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.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Flutiform 500/20 µg BID, Flutiform 250/10 µg BID and Seretide Accuhaler 50/500 µg BID in people with Chronic Obstructive Pulmonary Disease, run by Mundipharma Research Limited at 5 sites in 5 countries.
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 6 inclusion and 16 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, China, New Zealand, South Korea, Taiwan. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Average pre-dose FEV1 (time frame: 26 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 28 Mar 2017.