Flutiform® Compared With Seretide® in the Treatment of COPD

You may be eligible if

• 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).