Clinical Research Directory

Inclusion Criteria: 1. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or once applicable written informed consent obtained by legal representative. 2. Outpatients with a diagnosis of COPD and including: 1. Smoking history of at least 10 pack years defined as \[(number of cigarettes smoked per day) x (number of years of smoking) / 20\], both current and ex-smokers are eligible. 2. Use of bronchodilators in the previous 2 months to visit 1. 3. Post-bronchodilator FEV1 \< 60% of the predicted normal value. 4. Post-bronchodilator FEV1/FVC \< 0.7. 5. A ≥ 5% response to a reversibility test. 6. A Baseline Dyspnoea Index (BDI) focal score less or equal than 10 (to be met also at visit 2). 3. History of no more than one COPD exacerbation in the previous 12 months (without considering the last 2 months) to visit 1. 4. A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Accuhaler®, circular moulded plastic inhaler) inhalers. Main Exclusion Criteria: 1. Diagnosis of asthma or respiratory disorders (other than COPD) which could interfere with data interpretation according to the investigator's opinion. 2. Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they met the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or were using one or more of the following acceptable methods of contraception: 1. Surgical sterilization (e.g., bilateral tubal ligation, hysterectomy); 2. Hormonal contraception (implantable, patch, oral, injectable); 3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository. 4. Continuous abstinence (e.g. nuns). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception. Reliable contraception should have been maintained throughout the study and for 30 days after study drug discontinuation. 3. Clinical or functional unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. uncontrolled coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which could impact the evaluation of the results of the study according to investigator's judgement. 4. Patient with narrow-angle glaucoma. 5. Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which could impact the evaluation of the results of the study and the safety of the patient according to investigator's judgement. 6. Patients with COPD exacerbation (see previous at inclusion criteria no. 3) in the 2 months prior to screening and during the study period. 7. Patients requiring long term (\> 12 hours daily) oxygen therapy for chronic hypoxemia. 8. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period. 9. Patients with known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in the study drugs. 10. Patients who had evidence of alcohol or drug abuse, who were not compliant with the study protocol or not compliant with the study treatments according to investigator's judgement. 11. Major surgery in the previous 3 months and during the trial which could affect patient's compliance in the study procedures (e.g. spirometry). 12. Participation in another clinical trial with an investigational drug in the 2 months preceding visit 1. 13. Patients requiring chronic mechanical ventilation for COPD