Chronic obstructive pulmonary disease (COPD) MedDRA version: 18.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Flutiform® 125 microgram/5 microgram per actuation pressurised inhalation suspension.
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: FLUTICASONE PROPIONATE
CA
Sponsors
Mundipharma Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 765
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 during the 52-week treatment period.;Secondary Objective: • 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 during the 52-week treatment period • Compare flutiform (at each dose) with formoterol 12 µg (1 puff bid) for the secondary efficacy and safety endpoints.;Primary end point(s): Primary efficacy endpoint: • Annualised rate of moderate and severe COPD exacerbations during the 52-week treatment period (based on medical intervention). ;Timepoint(s) of evaluation of this end point: At the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints for high and medium dose of flutiform® • The pre-morning dose FEV1 values at each post-baseline time-point • Annualised Rate of COPD Exacerbations (EXACT) • Time to First Moderate or Severe COPD Exacerbation (Medical Intervention) • Saint George’s Respiratory Questionnaire for COPD • COPD Assessment Test Score • Study Rescue Medication Use • Percentage Change in Awakening-free nights • EXACT-RS dyspnoea score and EXACT-RS total score • Other Pulmonary Function Parameters • Time to Each COPD Exacerbation • Other Annualised Rates of COPD Exacerbations • Discontinuations Due to Lack of Efficacy • Average Change in Sleep Disturbance Scores • Days of Hospitalisaton • Treatment Compliance Analyses;Timepoint(s) of evaluation of this end point: At the end of the treatment. | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United Kingdom
Contacts
Public ContactEuropean Medical Operations
Mundipharma Research Limited
Outcome results
None listed