Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide 100 μg bid; Aclidinium bromide 200 μg bid; Aclidininum bromide 400 μg bid; Placebo; Formoterol 12 μg bid
Intervention description: Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days; Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days; Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days; Placebo via inhalation in the morning and evening for 7 days; Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days
Intervention MeSH terms: Bromides; Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The present trial is conducted to further assess the efficacy by means of serial spirometry,
      safety and tolerability of three doses of aclidinium bromide administered twice a day
      compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with
      moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment.
      Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between
      them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a
      follow up contact 14-days after last treatment dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and non-pregnant, non-lactating females aged ≥ 40.

          2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the
             Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines:
             (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC <
             70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).

          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 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. Female patients at least 1 year post-menopausal, surgically sterile (defined as having
             a hysterectomy or tubal ligation), or practicing a medically approved and highly
             effective method of contraception.

          6. Patients who understand the study procedures 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. Clinically significant respiratory conditions other than COPD 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. Clinically significant cardiovascular conditions

          6. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.

          7. Presence of narrow-angle glaucoma.

          8. QTcB) above 470 milliseconds in the ECG performed at Screening Visit,

          9. Patient who does not maintain regular day/night, waking/sleeping cycles