Status:
COMPLETED
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 pulmon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
933 Patients enrolled
Trial Details
Trial ID
NCT01908140
Start Date
September 1 2013
End Date
August 1 2014
Last Update
March 7 2016
Active Locations (126)
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1
Almirall Investigational Site
Feldbach, Austria, 8330
2
Almirall Investigational Site
Feldkirch, Austria, 6800
3
Almirall Investigational Site
Grieskirchen, Austria, A-4710
4
Almirall Investigational Site
Linz, Austria, 4020