Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium/Formoterol; Placebo
Intervention description: Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler; Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 267.0
Sex: All
Minimum age: 40 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The present study is planned to evaluate the effect of the aclidinium bromide/formoterol
      fumarate 400/12 μg FDC BID on the hyperinflation, exercise endurance and physical activity in
      patients with moderate to severe COPD. Additionally, the effect of the behavioural
      intervention on top of aclidinium bromide/formoterol fumarate 400/12 μg will be assessed both
      on the exercise endurance and the physical activity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and non-pregnant, non-lactating females aged ≥ 40.

          2. 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.

          3. Functional residual capacity (FRC) measured by body plethysmography at Visit 1 ≥ 120%
             of predicted value.

          4. Patients with modified Medical Research Council dyspnea scale (mMRC) ≥ 2 at Visit 1.

          5. Current or former cigarette smokers with a smoking history of at least 10 pack-years
             at Visit 1

          6. Patients willing to participate in the telecoaching program during the four last weeks
             and to enhance their physical activity

          7. 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:

          1. History or current diagnosis of asthma.

          2. 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.

          3. Patients who have been hospitalised for an acute COPD exacerbation within 3 months
             prior to Visit 1 or during the run-in period.

          4. Clinically significant respiratory conditions other than COPD.

          5. Use of long-term oxygen therapy (≥ 15 hours/day).

          6. Oxygen saturation ≤ 85% as measured by pulse oximetry during exercise testing at Visit
             1, Visit 2 or Visit 3 prior to randomisation.

          7. Patients with a Body Mass Index (BMI) ≥ 40kg/m2.

          8. 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.

          9. Patients with clinically significant cardiovascular conditions.

         10. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or
             hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated
             hypertension.

         11. Patient with known non-controlled history of infection with human immunodeficiency
             virus (HIV) and/or active hepatitis.

         12. Patients with clinically relevant abnormalities in the results of the blood pressure,
             ECG, or physical examination at Visit 1.

         13. 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

         14. 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

         15. Patients with other relevant comorbidities that make the patient nor suitable to
             follow-up study procedures and/or could affect physical activity

         16. 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.

         17. Patients with history of hypersensitivity reaction to inhaled anticholinergics,
             sympathomimetic amines or inhaled medication or any component thereof (including
             report of paradoxical bronchospasm)

         18. Patients for whom the use of anticholinergic drugs is contraindicated (acute urinary
             retention, symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle
             glaucoma)

         19. Patients unable to properly use a multidose dry powder inhaler or a pressurized
             metered-dose inhaler (pMDI).

         20. 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.

         21. 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).

         22. Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night
             shift workers, sleep apnea).

         23. Patients unable to give their consent, or patients of consenting age but under
             guardianship, or vulnerable patients