Chronic Obstructive Pulmonary DiseasePhase 3NCT01946620
A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD
A Phase 3 study testing Flutiform and Formoterol in people with Chronic Obstructive Pulmonary Disease, run by Mundipharma Research Limited at 15 sites in 15 countries.
Trial summary
Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study. 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 and Formoterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,767 participants
- Where
- 15 sitesin 15 countries
- Study dates
- Oct 2013to May 2016
- 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 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:
- Female subjects of child bearing potential (less than 1 year post-menopausal) must have a negative urine pregnancy test prior to first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of birth control throughout the study such as sterilisation, implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner.
- Male subjects with a partner of child bearing potential must be willing to use adequate and highly effective methods of birth control throughout the study
- Smoking history of ≥10 packs per year.
- Diagnosis of COPD
- History of ≥ moderate or severe COPD exacerbations in previous year.
Show all 10Show fewer
- Willing and able to replace current COPD therapy with study medication.
- Able to demonstrate correct use of a pMDI without a spacer.
- 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 (see section 10)
- 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) at least 12 hours daily or mechanical ventilation
Show all 16Show fewer
- Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities reflective of active disease 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 or contraindication to any of the study drugs 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
15 sites in 15 countries.
15 sites in 15 countries
About this study
Official title: A Randomised, Double-blind, Double Dummy, Parallel Group Study Comparing Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 250/10 µg (2 Puffs BID) and Flutiform® 125/5 µg (2 Puffs BID) Versus Formoterol Fumarate Dihydrate (Atimos®) 12 µg (1 Puff BID) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.
Read the detailed description
This study is a multi-centre, randomised, double-blind, active-controlled, parallel-group study, in male and female subjects who will be assigned into 1 of 3 treatment groups based on 1:1:1 ratio. Following a 2 week run-in phase all subjects will receive treatment for 1 year (52 weeks) followed by a final follow up 2 weeks after their last visit, during this time subjects will be required to attend 10 clinic visits while the final follow up can be completed by telephone. Throughout the study subjects will be assessed on a mixture of symptom based measurements as well as lung function tests to monitor their progress in the study.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Flutiform, Formoterol
- Keywords
- Chronic Obstructive Pulmonary Disease, Exacerbations, 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.
FlutiformDrug
FormoterolDrug
| Study group | Role | What they receive |
|---|---|---|
| Flutiform 250/10 micrograms | Experimental | Flutiform 250/10 µg (2 puffs twice daily) Receives: Drug: Flutiform |
| Flutiform 125/5 micrograms | Experimental | Flutiform 125/5 µg (2 puffs twice daily) Receives: Drug: Flutiform |
| Formoterol 12 micrograms | Active comparator | Formoterol 12 µg 1 puff twice daily Receives: Drug: Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual rate of moderate and severe COPD exacerbations
To show superiority in the efficacy of flutiform 250/10 µg (2 puffs BID) compared with formoterol 12 µg (1 puff BID) based on the annual rate of moderate and severe COPD exacerbations
Measured: 52 weeks
Secondary outcomes (2)
Annual rate of moderate and severe COPD exacerbations
To show superiority in the efficacy of flutiform 125/5 µg (2 puffs BID) compared with formoterol 12 µg (1 puff BID) based on the annual rate of moderate and severe COPD exacerbations. (Different dose to Primary Outcome)
Measured: 52 Weeks
Efficacy confirmed by lack of exacerbations, lung function and safety by collection of adverse events in all patients throughout the study.
To compare flutiform (at each dose) with formoterol 12 µg (1 puff BID) for the secondary efficacy, and safety endpoints.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionApr 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,767 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
- NCT01946620
- Sponsor's protocol ID
- FLT3509
- Other IDs
- 2012-004162-17
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2013
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Double Dummy, Parallel Group Study Comparing Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 250/10 µg (2 Puffs BID) and Flutiform® 125/5 µg (2 Puffs BID) Versus Formoterol Fumarate Dihydrate (Atimos®) 12 µg (1 Puff BID) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT01946620
- Acronym / sponsor ID
- FLT3509
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Exacerbations, FEV1 ≤ 50%
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,767 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Sep 2013 (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.
Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.
Detailed description
This study is a multi-centre, randomised, double-blind, active-controlled, parallel-group study, in male and female subjects who will be assigned into 1 of 3 treatment groups based on 1:1:1 ratio. Following a 2 week run-in phase all subjects will receive treatment for 1 year (52 weeks) followed by a final follow up 2 weeks after their last visit, during this time subjects will be required to attend 10 clinic visits while the final follow up can be completed by telephone. Throughout the study subjects will be assessed on a mixture of symptom based measurements as well as lung function tests 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 250/10 micrograms | Experimental | Drug: FlutiformFlutiform 250/10 µg (2 puffs twice daily) |
| Flutiform 125/5 micrograms | Experimental | Drug: FlutiformFlutiform 125/5 µg (2 puffs twice daily) |
| Formoterol 12 micrograms | Active comparator | Drug: FormoterolFormoterol 12 µg 1 puff twice daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or Female subjects aged ≥ 40 years at screening visit:
- Smoking history of ≥10 packs per year.
- Diagnosis of COPD
- History of ≥ moderate or severe COPD exacerbations in previous year.
- Willing and able to replace current COPD therapy with study medication.
Key exclusion criteria (16 listed)
- Ongoing moderate or severe exacerbation of COPD (see section 10)
- 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 | Drug | Flutiform 125/5 micrograms, Flutiform 250/10 micrograms |
| Formoterol | Drug | Formoterol 12 micrograms |
Primary outcome
Annual rate of moderate and severe COPD exacerbations
Time frame: 52 weeks
To show superiority in the efficacy of flutiform 250/10 µg (2 puffs BID) compared with formoterol 12 µg (1 puff BID) based on the annual rate of moderate and severe COPD exacerbations
2 secondary outcomes
Annual rate of moderate and severe COPD exacerbations
Time frame: 52 Weeks
Efficacy confirmed by lack of exacerbations, lung function and safety by collection of adverse events in all patients throughout the study.
Time frame: 52 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 24 Oct 2018.
- Link to ResultsLink provided by the sponsor.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
15 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flutiform and Formoterol in people with Chronic Obstructive Pulmonary Disease, run by Mundipharma Research Limited at 15 sites in 15 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 10 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 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Bulgaria, Germany, Hungary, Latvia, Lithuania and 10 more countries. 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 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?
Annual rate of moderate and severe COPD exacerbations (time frame: 52 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 24 Oct 2018.