Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00615992

First received: January 24, 2008

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: June 30, 2009

Study Type:	Observational
Study Design:	Observational Model: Cohort
Condition:	Pulmonary Disease, Chronic Obstructive
Intervention:	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
Patients With Stable COPD of Varying Severities	treatment with Spiriva for 3-4 weeks

Participant Flow: Overall Study

	Patients With Stable COPD of Varying Severities
STARTED	754
COMPLETED	754
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Patients With Stable COPD of Varying Severities	treatment with Spiriva for 3-4 weeks

Baseline Measures

	Patients With Stable COPD of Varying Severities
Number of Participants [units: participants]	754
Age [units: years] Mean ± Standard Deviation	63.0 ± 12.5
Gender, Customized ^[1] [units: participants]
Female	269
Male	414
Missing	71

[1]	687 eligible for efficacy analysis (complete data set available) Throughout this report, the discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.

Outcome Measures

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1. Primary:

Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

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2. Secondary:

Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

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3. Secondary:

Global Assessment of Efficacy by Patient [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

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4. Secondary:

Global Assessment of Tolerability by Patient [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

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5. Secondary:

Global Assessment of Efficacy by Physician [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]

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6. Secondary:

Global Assessment of Tolerability by Physician [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 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: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00615992 History of Changes
Other Study ID Numbers:	205.398
Study First Received:	January 24, 2008
Results First Received:	June 30, 2009
Last Updated:	May 18, 2012
Health Authority:	Austria: Federal Office for Safety in Health Care

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