Efficacy and Safety of Four Doses of Glycopyrronium Bromide in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium - Tabular View

Tracking Information

First Received Date ^ICMJE

July 13, 2007

Last Updated Date

December 17, 2008

Start Date ^ICMJE

July 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The efficacy of NVA237 in patients with stable COPD - trough forced expiratory volume in 1 second (mean of 23h 15min and 23h 45min post dose) following 7 days of treatment, by comparing four doses of NVA237 (12.5, 25, 50 and 100 μg o.d.) with placebo [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00501852 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Individual timepoint FEV1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To explore additional efficacy, safety and tolerability of the four doses of NVA237 in comparison with placebo delivered by the Single Dose Dry Powder Inhaler (SDDPI) and with tiotropium (18μg) delivered by the Handihaler as an active control.

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Four Doses of Glycopyrronium Bromide in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, 4 Period Incomplete Block Cross-Over, Multi-Center, Multiple Dose (7 Days) Dose-Ranging Study to Assess the Efficacy and Safety of 4 Doses of NVA237 in Patients With Stable COPD, Compared to Seven Days Treatment With Tiotropium (18μg Once Daily, Open Label) as an Active Control

Brief Summary

This study will assess the efficacy and safety of glycopyrronium bromide in patients with stable COPD, in comparison to an active comparator.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Drug: NVA237
Drug: Placebo
Drug: Tiotropium

Study Arms / Comparison Groups

Experimental: NVA237 12.5 µg
Experimental: NVA237 25 µg
Experimental: NVA237 50 µg
Experimental: NVA237 100 µg
Placebo Comparator: Placebo
Active Comparator: Tiotropium bromide

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Patients with moderate to severe COPD according to the Gold Guidelines (2006).
Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH 1993], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables [Japan Respiratory Society 2001].

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrowangle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.
Patients with a history of asthma indicated by (but not limited to):
1. Blood eosinophil count > 400/mm3
2. Onset of symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, France, Japan

Administrative Information

NCT ID ^ICMJE

NCT00501852

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CNVA237A2205

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceuticals

Novartis

Information Provided By

Novartis

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP