Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237 12.5 µg once daily; NVA237 25.0 µg once daily; NVA237 12.5 µg twice daily; NVA237 50.0 µg once daily; NVA237 25.0 µg twice daily; NVA237 100.0 µg once daily; NVA237 50.0 µg twice daily; Placebo to NVA237 once daily
Intervention description: NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.; NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.; NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.; NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.; NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.; NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.; NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.; Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 388.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This study was designed to investigate the efficacy and safety of NVA237, a long-acting
      muscarinic antagonist, in patients with moderate to severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients age 40 years or more

          -  Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified
             by the Global Initiative for COPD (GOLD) Guidelines, 2008

          -  Smoking history of at least 10 pack-years

          -  Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) <80% and ≥30% of the
             predicted normal value

          -  Post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.7

          -  Symptomatic patients, according to daily electronic diary data between visit 2 (Day
             -8) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7
             days prior to visit 3

        Exclusion Criteria:

          -  Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or
             antibiotics and/or hospitalization in the 6 weeks prior to the first visit

          -  Patients who have had a respiratory tract infection within 4 weeks prior to the first
             visit

          -  Patients with concomitant pulmonary disease

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular co-morbid conditions

          -  Patients with a history of asthma or a blood eosinophil count >600/mm3 or onset of
             symptoms prior to 40 years

          -  Patients with eczema, known high IgE levels or a known positive skin prick test

          -  Patients participating in the active phase of a pulmonary rehabilitation programme

          -  Patients contraindicated for the treatment with anticholinergics, long and
             short-acting beta-2 agonists or sympathomimetic amines

          -  Patients with a history of alpha-1 anti-trypsin deficiency

          -  Patients on long term oxygen therapy (>15hr per day)

          -  Other protocol-defined inclusion/exclusion criteria may apply