Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)

Exclusion criteria

• . Patients requiring use of the following medications:
• . COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period;
• . Changes in dose, schedule, formulation or product of oral xanthine derivatives (e.g. theophylline) in the month prior to the screening visit or during the run-in period. Stop of xanthines prior to the screening visit was allowed;
• . Known respiratory disorders other than COPD which may have impacted the efficacy of the study treatment according to the Investigator's judgement. This could have included, but was not limited to, α-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease;
• . Diagnosis of asthma, history of allergic rhinitis or atopy (atopy which may have risen contra-indications or impacted the efficacy of the study according to the Investigator's judgement);
• . Patients treated with long-acting antihistamines (e.g. astemizole, terfenadine) unless taken at stable regimen at least 2 months prior to screening and maintained constant during the study, or if taken as required (PRN);
• . Patients requiring long-term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
• . History of hypersensitivity to β2-agonists, corticosteroids or any of the excipients contained in any of the formulations used in the study;