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

Study Overview
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Brief Summary
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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)

Official Title
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A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Aclidinium Bromide / Formoterol Fumarate
* Drug: Salmeterol / Fluticasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aclidinium Bromide / Formoterol Fumarate<br>Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks | Drug: Aclidinium Bromide / Formoterol Fumarate<br> <br> |
| Active Comparator: Salmeterol / Fluticasone propionate<br>Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks | Drug: Salmeterol / Fluticasone<br> <br> * Other names: Advair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 | Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration | At Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition Dyspnoea Index (TDI) Focal Score 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) | At Week 24 |