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

This study has been completed.

Study NCT00501852 Information provided by Novartis

First Received on July 13, 2007. Last Updated on December 22, 2010 History of Changes

Results First Received: December 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Chronic Obstructive Pulmonary Disease
Interventions:	Drug: NVA237 Drug: Placebo Drug: Tiotropium

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Overall Study	No text entered.

Participant Flow: Overall Study

	Overall Study
STARTED	83
COMPLETED	78
NOT COMPLETED	5
Adverse Event	3
Withdrawal by Subject	2

Baseline Characteristics

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Reporting Groups

	Description
Overall Study	No text entered.

Baseline Measures

	Overall Study
Number of Participants [units: participants]	83
Age [units: years] Mean ± Standard Deviation	64.4 ± 9.05
Age, Customized [units: participants]
40-64 years	39
>= 65 years	44
Gender [units: participants]
Female	14
Male	69
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	25
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	58
More than one race	0
Unknown or Not Reported	0

Outcome Measures

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1. Primary:

Trough Forced Expiratory Volume in 1 Second (FEV1) Following 7 Days of Treatment [ Time Frame: Day 7 ]

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2. Secondary:

Least Squares Means of FEV1 (L) at Day 1, by Timepoint [ Time Frame: Day 1 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00501852 History of Changes
Other Study ID Numbers:	CNVA237A2205
Study First Received:	July 13, 2007
Results First Received:	December 22, 2010
Last Updated:	December 22, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency