Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200µg Once a Day) in Patients With Moderate to Severe COPD

This study has been completed.

Study NCT00510510 Information provided by Novartis

First Received on August 1, 2007. Last Updated on March 8, 2011 History of Changes

Results First Received: December 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Chronic Obstructive Airway Disease
Interventions:	Drug: NVA237 Drug: Placebo

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
NVA237 100 µg	Administered as a single -dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
NVA237 200 µg	SDDPI once a day in the morning for 28 days.
Placebo	Matching placebo to NVA237 inhalation capsules, administered via SDDPI.

Participant Flow: Overall Study

	NVA237 100 µg	NVA237 200 µg	Placebo
STARTED	92	98	91
COMPLETED	87	89	74
NOT COMPLETED	5	9	17
Adverse Event	4	3	6
Abnormal laboratory value(s)	0	0	0
Abnormal test procedure result(s)	0	0	0
Lack of Efficacy	0	1	1
Subjects no longer requires study drug	0	0	2
Withdrawal by Subject	1	2	3
Lost to Follow-up	0	0	1
Administrative problems	0	0	0
Death	0	0	0
Protocol Violation	0	3	4

Baseline Characteristics

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Reporting Groups

	Description
NVA237 100 µg	SDDPI once a day in the morning for 28 days.
NVA237 200 µg	SDDPI once a day in the morning for 28 days.
Placebo	Matching placebo SDDPI.

Baseline Measures

	NVA237 100 µg	NVA237 200 µg	Placebo	Total
Number of Participants [units: participants]	92	98	91	281
Age [units: years] Mean ± Standard Deviation	64.2 ± 7.93	62.6 ± 9.04	63.4 ± 9.44	63.4 ± 8.82
Gender [units: participants]
Female	35	29	27	91
Male	57	69	64	190
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	17	15	11	43
Not Hispanic or Latino	72	79	76	227
Unknown or Not Reported	3	4	4	11
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	1	0	1
Black or African American	0	3	3	6
White	90	94	88	272
More than one race	0	0	0	0
Unknown or Not Reported	2	0	0	2

Outcome Measures

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1. Primary:

Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) [ Time Frame: 28 days ]

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2. Secondary:

Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day [ Time Frame: 28 Days ]

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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
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Results Point of Contact:

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

No publications provided by Novartis

Publications automatically indexed to this study:

Vogelmeier C, Verkindre C, Cheung D, Galdiz JB, Güçlü SZ, Spangenthal S, Overend T, Henley M, Mizutani G, Zeldin RK. Safety and tolerability of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Pulm Pharmacol Ther. 2010 Oct;23(5):438-44. Epub 2010 Apr 21.

Responsible Party:	external affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00510510 History of Changes
Other Study ID Numbers:	CNVA237A2206
Study First Received:	August 1, 2007
Results First Received:	December 23, 2010
Last Updated:	March 8, 2011
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Spain: Spanish Agency of Medicines; Turkey: Ministry of Health