BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium Bromide; Placebo
Intervention description: Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler; Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler
Intervention MeSH terms: Bromides
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 40 Years
Maximum age: 110 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID
      compared with placebo on COPD symptoms in a symptomatic patients population with moderate
      COPD and chronic bronchitis, and particularly assess the effects in cough by using specific
      tools to assess the occurrence and impact of this relevant COPD symptom.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing
             potential will follow specific study requirements.

          2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years

          3. Patients with a clinical diagnosis of moderate COPD, with a post bronchodilator test
             available within 6 months prior to Visit 1 (Screening), with FEV1 ≥50% and <80% and
             FEV1/FVC <70%.

          4. Symptomatic patients with a CAT≥10 at Screening and Randomisation Visit (Visit 1 and
             2)

          5. Clinical Diagnosis of Chronic Bronchitis (defined as "presence of cough and sputum
             production for at least 3 months in each of 2 consecutive years")

          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

        Exclusion Criteria:

          1. History or current diagnosis of asthma.

          2. Patients who suffered from a moderate or severe COPD exacerbation in the last year
             prior to Visit 1 (Screening) or during the run-in period.

          3. Patients who develop a respiratory tract infection within 6 weeks before Visit 1
             (Screening) or during the run-in period.

          4. Clinically significant respiratory and cardiovascular conditions thought to be
             contributing to cough or likely to interfere in the conduct of the study.

          5. Patient who in the investigator's opinion may need to start a pulmonay rehabilitation
             program during the study and/or patients who started/finished it within 3 months prior
             to Screening Visit.

          6. Use of long-term oxygen therapy.

          7. Patients in non-stable treatment with angiotensin-converting enzyme inhibitors or
             opiates.

          8. Patients in treatment with mucolytics, antihistamines, expectorants or antitussive
             drugs including over-the-counter medication.

          9. Patient who does not maintain regular day/night, waking/sleeping cycles including
             night shift workers.

         10. Patient with clinically relevant abnormalities in the results of the physical
             examination at Visit 1 (Screening)

         11. Patient with a history of hypersensitivity reaction to inhaled
             anticholinergics,sympathomimetic amines, or inhaled medication or any component
             thereof (including report of paradoxical bronchospasm).

         12. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute
             urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.

         13. Patient with known non-controlled history of infection with human immunodeficiency
             virus (HIV) and/or active hepatitis

         14. Current diagnosis of cancer other than basal or squamous cell skin cancer

         15. Patient with any other serious or uncontrolled physical or mental dysfunction

         16. 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.

         17. Patient unlikely to be cooperative or that can not comply with the study procedures

         18. Patient treated with any investigational drug within 30 days (or 6 half-lives,
             whichever is longer) prior to Visit 1 (Screening).

         19. 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.

         20. Any other conditions that, in the investigator's opinion, might indicate the patient
             to be unsuitable for the study.