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

• ClinicalTrials.gov Identifier: NCT00856193
• Recruitment Status: Completed
• First Posted: March 5, 2009
• Results First Posted: May 6, 2011
• Last Update Posted: September 14, 2016
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Placebo; Drug: NVA237	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, 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).
• Study Start Date: February 2009
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. 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 ]
   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.
2. 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 ]
   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.
3. Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) [ Time Frame: Day 14 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00856193
• Other Study ID Numbers: CNVA237A2207; 2008-006849-28 ( EudraCT Number )
• First Posted: March 5, 2009
• Results First Posted: May 6, 2011
• Last Update Posted: September 14, 2016
• Last Verified: June 2011

Keywords provided by Novartis:

COPD; Bronchodilator

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Glycopyrrolate; Adjuvants, Anesthesia; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs