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Flutiform® Compared With Seretide® in the Treatment of COPD

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)

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02195375
Enrollment
923
Registered
2014-07-21
Start date
2014-09-30
Completion date
2016-05-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease, FEV1 ≤ 50%

Brief summary

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.

Interventions

DRUGFlutiform 500/20 µg BID
DRUGFlutiform 250/10 µg BID
DRUGSeretide Accuhaler 50/500 µg BID

Sponsors

Mundipharma Research Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: 1. Male or Female subjects aged ≥ 40 years at screening visit. 2. Diagnosis of COPD 3. Willing and able to replace current COPD therapy with study medication. 4. Able to demonstrate correct use of a pMDI with or without a spacer and Accuhaler. 5. Willing and able to attend all study visits and complete study assessments. 6. Able to provide signed informed consent. Exclusion: 1. Ongoing moderate or severe exacerbation of COPD in the 2 weeks before screening. 2. Current diagnosis of asthma. 3. Documented evidence of α1-antitrypsin deficiency as the underlying cause of COPD. 4. Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans. 5. Previous lung resection. 6. Use of long-term oxygen therapy (LTOT) or mechanical ventilation. Note: LTOT is defined as \>15 hours use per day 7. Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities not believed to be due to COPD. 8. Evidence of uncontrolled cardiovascular disease. 9. Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease. 10. 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). 11. Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device. 12. Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study. 13. Known or suspected history of drug or alcohol abuse in the last 2 years. 14. Requiring treatment with any of the prohibited concomitant medications. 15. Known or suspected hypersensitivity to study drug or excipients. 16. Received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).

Design outcomes

Primary

MeasureTime frame
Average pre-dose FEV126 weeks

Secondary

MeasureTime frame
Average 1 hour Post dose FEV1, FVC, FEV626 Weeks

Other

MeasureTime frame
Moderate and Severe COPD Exacerbations26 weeks
COPD Assessment TestChange from baseline to week 8, week 14, week 26
Average capacity of daily living during the morning score26 weeks

Countries

Australia, China, New Zealand, South Korea, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026