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

Chronic Obstructive Pulmonary Disease Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856193
• Other study ID #: CNVA237A2207
• Secondary ID: 2008-006849-28
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2009
• Last updated: June 8, 2011
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Placebo
Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.
• NVA237
NVA237 50 µg capsules were supplied for inhalation once daily with Concept 1 device.

Locations

Country	Name	City	State
Germany	Harrison Clinical Research Deutschland GmbH	,Albrechtstrasse 14	Munich
United States	Spartanburg Medical Research	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes