Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01154127 | Completed Phase 3 Results

• 2 other identifiers: CNVA237A23102010-018597-20
• Study Type: interventional
• Target: 108
• Locations: 5 countries
• Sites: 10

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

NVA237; COPD; bronchodilator; exercise endurance

Outcome Measures

Primary Outcomes (1)

• Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment

  SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.

  Day 21

Secondary Outcomes (8)

• Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment

  Day 21

• 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

  Day 21

• Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)

  Day 21

• Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)

  Day 21

• Specific Airways Conductance (SGaw)

  Day 21

Study Arms (2)

NVA237 followed by Placebo

EXPERIMENTAL

Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days Period 2: Matching placebo via NEOHALER inhaler device for 21 days The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. Salbutamol (albuterol) was used as rescue medication throughout the study.

Drug: NVA237; Drug: Placebo

Placebo followed by NVA237

EXPERIMENTAL

Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. Salbutamol (albuterol) was used as rescue medication throughout the study.

Drug: NVA237; Drug: Placebo

Interventions

NVA237 DRUG

50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

NVA237 followed by Placebo; Placebo followed by NVA237

Placebo DRUG

Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

NVA237 followed by Placebo; Placebo followed by NVA237

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Spartanburg Medical Research, 485 Simuel Road

Spartanburg, South Carolina, 29303, United States

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Frankfurt, Germany

Location

Novartis Investigative Site

Mainz, Germany

Location

Novartis Investigative Site

Mannheim, Germany

Location

Novartis Investigative Site

Wiesbaden, Germany

Location

Novartis Investigative Site

Woehrendamm, Germany

Location

Novartis Investigative Site

Verona, Italy

Location

Novartis Investigative Site

Bucharest, Romania

Location

Novartis Investigative Site

Manchester, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22973092 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 7, 2012
• Results First Posted: May 7, 2012

Record last verified: 2012-04

Locations

IT (1); US (1); GB (1); RO (1); DE (6)