Effect of NVA237 on Exercise Endurance 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; Placebo
Intervention description: 50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily; Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: NVA237; COPD; bronchodilator; exercise endurance

Summary:

      The ability for patients with COPD to exercise is limited due to the deterioration of their
      lung function. NVA237 is being developed to treat COPD. This study is designed to look at how
      well NVA237 improves the ability to exercise in patients with moderate to severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who signed an Informed Consent Form prior to initiation of any study-related
             procedure

          -  Patients with moderate to severe stable COPD (clinical diagnosis in compliance with
             GOLD 2008)

          -  Current or ex-smokers with a smoking history ≥ 10 pack years. (Ten pack-years were
             defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years
             etc.).

          -  Patients with a post-bronchodilator FEV1 ≥ 40 and < 70% of the predicted normal, and
             postbronchodilator FEV1/FVC < 0.7 during screening. (Post referred to the highest
             post-bronchodilator value after inhalation of 80 μg ipratropium bromide)

          -  Increase in FEV1 from pre- to post-bronchodilator assessment of ≥ 5%

        Exclusion Criteria:

          -  Pregnant women or nursing mothers

          -  Women of child-bearing potential

          -  Patients who had a COPD exacerbation (whether hospitalized or not) in the 6 weeks
             prior to Visit 1 or between Visit 1 and Visit 4

          -  Patients who had a lower respiratory tract infection in the 6 weeks prior to Visit 1

          -  Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia

          -  Patients with resting (5 min) oxygen SaO2 (or SpO2) saturation on room air of < 85%

          -  Patients with a maximum workload (Wmax) value < 20 W (as determined by the incremental
             cycle endurance test) at Visit 2.

          -  Patients whose exercise endurance time at sub-maximal workload was above 25 min at
             baseline

          -  Patients with a clinically significant abnormality on the screening or baseline ECG
             who in the judgment of the investigator would have been at potential risk if enrolled
             into the study

          -  Patients with a history of long QT syndrome or whose QTc was prolonged (> 450 ms for
             males and > 470 ms females) at screening (Fredericia's correction)

        Other protocol-defined inclusion/exclusion criteria applied