Clinical trial NCT01154127: Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study to Assess the Effect of 50µg Inhaled NVA237 on Exercise Endurance in Patients With Moderate to Severe COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: NVA237
COPD
bronchodilator
exercise endurance
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment
timeFrame: Day 21
Secondary outcomes:
measure: Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment
timeFrame: Day 21
measure: 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
timeFrame: Day 21
measure: Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)
timeFrame: Day 21
measure: Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)
timeFrame: Day 21
measure: Specific Airways Conductance (SGaw)
timeFrame: Day 21
measure: Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment
timeFrame: Day 21
measure: Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment
timeFrame: Day 21
measure: Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1
timeFrame: Day 1
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Spartanburg Medical Research, 485 Simuel Road
state: South Carolina
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Woehrendamm
country: Germany
facility: Novartis Investigative Site
city: Verona
country: Italy
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Beeh KM, Singh D, Di Scala L, Drollmann A. Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis. 2012;7:503-13. doi: 10.2147/COPD.S32451. Epub 2012 Jul 31.