Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium 200 μg / formoterol 12 μg; Placebo; Formoterol 12 μg; Aclidinium 200 μg; Aclidinium 200 μg / Formoterol 6 μg
Intervention description: Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily; Placebo control twice daily; Formoterol fumarate 12 μg twice daily; Aclidinium bromide 200 μg twice daily; Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 176.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Bronchitis; Chronic; Emphysema

Summary:

      The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations
      of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol
      fumarate, all administered BID in patients with stable, moderate to severe COPD.

      Every treatment period is 14-days long and there is a 7-days wash-out period in between them.
      The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow
      up contact 14-days after last treatment dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old,
             both inclusive.

          2. Patient with a clinical diagnosis of stable moderate to severe COPD according to the
             GOLD classification

          3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.

          4. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post
             inhalation of 400 mcg of salbutamol is 30% FEV1 <80% of the predicted normal value
             (i.e., 100 x Post-salbutamol < FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).

          5. Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post
             inhalation of 400 mcg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC <
             70%).

          6. Patient who is 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.

          7. Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable
             compared to the Screening Visit, according to the investigator's medical judgment

        Exclusion Criteria:

          1. History or current diagnosis of asthma or exercise-induced bronchospasm.

          2. Clinically significant respiratory conditions at the time of Inform Consent signature

          3. Hospitalisation due to COPD exacerbation within the previous 3 months.

          4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory
             tract) within the previous 6 weeks.

          5. Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic
             blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.

          6. Clinically significant cardiovascular conditions

          7. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.

          8. Presence of narrow-angle glaucoma.

          9. QTc [calculated according to Bazett's formulae (QTc=QT/RR1/2) above 470 milliseconds
             in the ECG performed at Screening Visit,

         10. Patient who does not maintain regular day/night, waking/sleeping cycles