NVA237 Versus Placebo 12-week Efficacy Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237; Placebo
Intervention description: NVA237 (glycopyrronium bromide) as a powder for inhalation in single-dose capsules.; Placebo powder for inhalation in single-dose capsules (matching those for NVA237).
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 440.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Anticholinergic; Antimuscarinic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; COPD; LAMA; Lung Disease; Lung Diseases, Obstructive; Lung Function; Muscarinic receptor antagonist; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases

Summary:

      The study serves to determine whether the treatment of patients with stable, symptomatic
      Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is
      efficient and safe. The efficacy and safety of the drug will be tested against a placebo
      treatment.

      The primary criterion to assess efficacy will be the difference between the serial lung
      function measurements of patients who have been treated for 12 weeks with NVA237 versus those
      that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1
      testing) will be conducted and the "area under the curve" will be the measure for the ability
      to breathe.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with
             airflow obstruction of level 2 and 3 according to the current Global initiative for
             chronic Obstructive Lung Disease (GOLD) strategy (2011).

          2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the
             predicted normal, and FEV1/ Forced Vital Capacity (FVC) < 0.70 when measured 45 min
             after the inhalation of 84 µg ipratropium bromide.

          3. Current or ex-smokers with at least 10 cigarette pack years smoking history.

        Exclusion criteria:

          1. Patients with a history of long QT syndrome, with a prolonged QTc measured during
             screening, or patients who have a clinically significant ECG abnormality at screening.

          2. History of malignancy of any organ system (other than localized basal cell carcinoma
             of the skin), treated or untreated, within the past 5 years, regardless of whether
             there is evidence of local recurrence or metastases.

          3. Pregnant or nursing (lactating) women. Women of childbearing potential unless using an
             effective method of contraception.

          4. Patients who in the judgment of the investigator, would be at potential risk if
             enrolled into the study.

          5. Patients who have a clinically significant concomitant disease at screening, including
             but not limited to clinically significant laboratory abnormalities, clinically
             significant renal, cardiovascular, neurological, endocrine, immunological,
             psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with
             uncontrolled diabetes, which could interfere with the assessment of the efficacy and
             safety of the study treatment.

          6. Patients with a body mass index (BMI) of more than 40 kg/m2.

          7. Patients contraindicated for treatment with, or having a history of reactions/
             hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or
             sympathomimetic amines.

          8. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or
             patients with a high blood eosinophil count during screening.

        Other protocol-defined inclusion/exclusion criteria may apply.