Phase 3
Completed N=108
Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01154127 ↗Enrolled (actual)
108
Serious AEs
0.5%
Results posted
May 2012
Primary outcomePrimary: Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment — 505.63; 416.70 seconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment |
505.63; 416.70 | — |
| SECONDARY Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment |
2.22; 2.02 | — |
| SECONDARY Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment |
2.22; 2.03; 2.49; 2.26; 2.39; 2.17 | — |
| SECONDARY Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) |
1.60; 1.35; 1.44; 1.33; 3.37; 3.00 | — |
| SECONDARY Slow Vital Capacity (SVC) and Total Lung Capacity (TLC) |
3.21; 3.14; 3.40; 3.14; 6.99; 7.17 | — |
| SECONDARY Specific Airways Conductance (SGaw) |
0.48; 0.40; 0.66; 0.42 | — |
| SECONDARY Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment |
5.64; 6.80 | — |
| SECONDARY Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment |
6.21; 7.05 | — |
| SECONDARY Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1 |
490.92; 447.78 | — |
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 450 ms for males and > 470 ms females) at screening (Fredericia's correction)
Other protocol-defined inclusion/exclusion criteria applied
Data sourced from ClinicalTrials.gov (NCT01154127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.