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

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).

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Placebo; Drug: NVA237

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Munich
    • Albrechtstrasse 14, Munich, Germany, 80636
      • Harrison Clinical Research Deutschland GmbH
• United States
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours 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.	From Day 1 to 0-24 hours after drug administration on Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours 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.	From day 1 to 0 -12 hours after drug administration on Day 14
Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours 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.	From Day 1 to 12 hours-24 hours after drug administration on Day 14
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)	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.	Day 14

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 4, 2009
• First Submitted That Met QC Criteria: March 4, 2009
• First Posted (Estimate): March 5, 2009

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: COPD; Bronchodilator
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: CNVA237A2207; 2008-006849-28 (EudraCT Number)