Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients

Inclusion criteria

• Males and non-pregnant, non-lactating females aged ≥ 40.
• Patients with a clinical diagnosis of COPD according to GOLD guidelines 2014, with a post bronchodilator FEV1 ≥ 40% and < 80% of the predicted value and FEV1/FVC < 70% at Visit 1.
• Functional residual capacity (FRC) measured by body plethysmography at Visit 1 ≥ 120% of predicted value.
• Patients with modified Medical Research Council dyspnea scale (mMRC) ≥ 2 at Visit 1.
• Current or former cigarette smokers with a smoking history of at least 10 pack-years at Visit 1
• Patients willing to participate in the telecoaching program during the four last weeks and to enhance their physical activity
• Patients who understand and are able to follow the study procedures, are cooperative and are willing to participate in the study as indicated by signing the informed consent.

Exclusion criteria

• History or current diagnosis of asthma.
• Any respiratory tract infection (including upper respiratory tract) or COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period.
• Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Visit 1 or during the run-in period.
• Clinically significant respiratory conditions other than COPD.
• Use of long-term oxygen therapy (≥ 15 hours/day).
• Oxygen saturation ≤ 85% as measured by pulse oximetry during exercise testing at Visit 1, Visit 2 or Visit 3 prior to randomisation.
• Patients with a Body Mass Index (BMI) ≥ 40kg/m2.
• Patient who may need to start a pulmonary rehabilitation program during the study and/or who started/finished it within 3 months prior to Visit 1 or during the run-in period.
• Patients with clinically significant cardiovascular conditions.
• Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
• Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
• Patients with clinically relevant abnormalities in the results of the blood pressure, ECG, or physical examination at Visit 1.
• Patients with any serious or uncontrolled physical or mental dysfunction that could place the patient at higher risk derived from his/her participation in the study or could confound the results
• Patients with conditions other than COPD that may contribute to dyspnoea and exercise limitation or with contraindications to clinical exercise testing according to ATS recommendations for CPET
• Patients with other relevant comorbidities that make the patient nor suitable to follow-up study procedures and/or could affect physical activity
• Patients who cycled < 2 minutes or > 15 minutes during the constant work-rate exercise tests conducted at Visit 2 (Run-in Visit) or at Visit 3 even after adjustment of the work load.
• Patients with history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
• Patients for whom the use of anticholinergic drugs is contraindicated (acute urinary retention, symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma)
• Patients unable to properly use a multidose dry powder inhaler or a pressurized metered-dose inhaler (pMDI).
• Patients using any prohibited medication (including IMP within 30 days (or 6 half-lives, whichever is longer) before Visit 1) or who have not undergone the required washout period.
• 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).
• Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers, sleep apnea).
• Patients unable to give their consent, or patients of consenting age but under guardianship, or vulnerable patients