A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD

Inclusion Criteria

• •Inclusion:
• •1. Male or Female subjects aged ≥ 40 years at screening visit:
• •1. 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.
• •2. 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 packs per year.
• •3. Diagnosis of COPD
• •4. History of ≥ moderate or severe COPD exacerbations in previous year.
• •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.
• •Exclusion:
• •1. Ongoing moderate or severe exacerbation of COPD (see section 10)
• •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) 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).