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A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00856193
First received: March 4, 2009
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  Purpose

This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: Placebo
Drug: NVA237
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Two-period Crossover Study to Investigate the Bronchodilatory Effect of 50 µg NVA237 Inhaled Once Daily in Patient With Chronic Obstructive Pulmonary Disease (COPD).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 [ Time Frame: From Day 1 to 0-24 hours after drug administration on Day 14 ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.


Secondary Outcome Measures:
  • Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14 [ Time Frame: From day 1 to 0 -12 hours after drug administration on Day 14 ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.

  • Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14 [ Time Frame: From Day 1 to 12 hours-24 hours after drug administration on Day 14 ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.

  • Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
    According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details.


Enrollment: 33
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo then NVA237 50μg
Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device.
 Drug: Placebo
Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.
Drug: NVA237
NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.
Experimental: NVA237 50μg then placebo
NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
 Drug: Placebo
Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.
Drug: NVA237
NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged greater than 40 years with COPD Current or ex-smokers

Exclusion Criteria:

  • Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856193

Locations
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Germany
Harrison Clinical Research Deutschland GmbH
,Albrechtstrasse 14, Munich, Germany, 80636
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00856193     History of Changes
Other Study ID Numbers: CNVA237A2207, 2008-006849-28
Study First Received: March 4, 2009
Results First Received: January 20, 2011
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation

Keywords provided by Novartis:
COPD
Bronchodilator

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013