study of aclidinium bromide/formoterol fumarate compared with salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (copd)


Eligibility criteria:
inclusion criteria: * adult male or non-pregnant, non-lactating female aged ≥40. * current or ex-cigarette smoker, with a smoking history of at least 10 pack-years * patients with a clinical diagnosis of copd according to gold guidelines 2013, with a post-bronchodilator fev1 \<80%, and fev1/fvc \< 70% at screening visits * symptomatic patients with a copd assessment test (cat) ≥10 at screening and randomisation visits * patient must be able to perform repeatable pulmonary function testing for fev1 according to ats/ers 2005 criteria at screening visits * patients eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained exclusion criteria: * history or current diagnosis of asthma * development of a respiratory tract infection or copd exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the screening visit or during the run-in period * clinically significant respiratory conditions * type i or uncontrolled type ii diabetes, uncontrolled hypo- or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension * patients who, in the investigator's opinion, may need to start a pulmonary rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to screening visit * use of long-term oxygen therapy (≥15 hours/day) * patients treated on daily basis with triple therapy (laba+lama+ics) within 4 weeks prior to the screening visit * patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers * clinically significant cardiovascular conditions * patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ecg parameters or in the physical examination at the screening visit * patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm) * patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy * patient with known non-controlled history of infection with human immunodeficiency virus (hiv) and/or active hepatitis * history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer * patient with any other serious or uncontrolled physical or mental dysfunction * patient with a history (within 2 years prior to screening visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment * patient unlikely to be cooperative or that can't comply with the study procedures * patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to screening visit * patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication * any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study