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Clinical Trials/EUCTR2012-004162-17-HU
EUCTR2012-004162-17-HUActive, not recruitingPhase 1

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 sites1,758 target enrollmentStarted: June 10, 2013Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
1,758
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar 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. = 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).

Investigators

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