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).

Mundipharma Research Limited0 sites1,530 target enrollmentStarted: July 24, 2013Last updated: April 11, 2016

Conditions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: Mundipharma Research Limited
Enrollment: 1,530

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1. Male or Female subjects aged = 40 years at screening visit
•a. 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.
•b. 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.
•2. Smoking history of = 10 pack years (equivalent to, for example, 20 cigarettes/day for 10 yrs or 10 cigarettes/day for 20 yrs ) (pack year = (number of cigarettes per day ÷ 20) x number of years of smoking)
•3. Diagnosis of COPD as evidenced by:
•a. Clinical symptoms of COPD (e.g. chronic cough, sputum production, dyspnoea) and
•b. Post-bronchodilator FEV1 / FVC ratio < 0.7 measured at screening and
•c. = 30 % to = 50 % FEV1 predicted normal measured at screening
•4. Documented history of = 1 moderate or severe COPD exacerbation in previous year (requiring treatment with systemic corticosteroids and/or antibiotics and/or hospitalisation)
•5. Willing and able to replace current COPD therapy with study medication
•6. Able to demonstrate correct use of a pMDI without a spacer
•7. Willing and able to attend all study visits and complete study assessments
•8. Able to provide signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 765
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 765

Exclusion Criteria

•1. Ongoing moderate or severe exacerbation of COPD (see section 10 of protocol)
•2. Current diagnosis of asthma
•3. Documented evidence of a1-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) at least 12 hours daily or mechanical ventilation
•7. Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities reflective of active disease 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 or contraindication to any of the study drugs or excipients
•16. Received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).
•17. the FEV1 is measured < 30 % predicted at any clinic visits
•18. Subject’s condition worsens to an extent that, in the Investigators opinion, the subject requires a change in the treatment regimen not allowed in the protocol

Investigators

Sponsor

Mundipharma Research Limited

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