Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: Salmeterol / Fluticasone
Drug: Aclidinium Bromide / Formoterol Fumarate

Registration Number: NCT01908140

Lead Sponsor: AstraZeneca

Brief 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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 933

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salmeterol / Fluticasone propionate	Salmeterol / Fluticasone	Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
Aclidinium Bromide / Formoterol Fumarate	Aclidinium Bromide / Formoterol Fumarate	Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks

Primary Outcome Measures

Name	Time	Method
Peak Forced Expiratory Volume in One Second (FEV1) at Week 24	At Week 24	Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration

Secondary Outcome Measures

Name	Time	Method
Transition Dyspnoea Index (TDI) Focal Score at Week 24	At Week 24	The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 ("major deterioration") to zero ("no change") to +3 ("major improvement"). Category scores are added to compute the Focal Score (from -9 to 9)