Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium Bromide / Formoterol Fumarate; Salmeterol / Fluticasone
Intervention MeSH terms: Fluticasone; Bromides; Formoterol Fumarate; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 933.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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