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

This study has been completed.

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00615992

Purpose

The primary goal of this PMS study is to document the efficacy of Spiriva to improve physical activity measured by a score that is recommended in national COPD guidelines for monitoring the course of the disease.

Condition	Intervention	Phase
COPD	Drug: Tiotropium	Phase IV

Drug Information available for: Tiotropium Tiotropium bromide

U.S. FDA Resources

Study Type:	Observational
Official Title:	Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Activities of daily living score after 21 to 28 days of treatment with Tiotropium [ Time Frame: 21 to 28 days ]

Secondary Outcome Measures:

dyspnea score after 21 to 28 days of treatment with Tiotropium assessment of efficacy and tolerability on 4 point scale [ Time Frame: 21 to 28 days ]

Estimated Enrollment:	1000
Estimated Study Completion Date:	June 2008

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Patients with GP-suspected COPD
3 or more positive answers in GOLD Could it be COPD questionnaire
Age over 40 years

EXCLUSION CRITERIA:

Patient treated with Spiriva in the past year
Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva
Patient with known narrow-angle glaucoma
Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction
Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min)
Pregnant or nursing women
Patient with any significant disease other than COPD which would exclude him/her from participating in the study
Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva's Austrian SPC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615992

Show 74 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

BI Austria GesmbH

More Information

Statement about the disclosure of the results of this study. This link exits the ClinicalTrials.gov site

Study ID Numbers:	205.398
Study First Received:	January 24, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00615992
Health Authority:	Austria: Bundesamt fur Sicherheit im Gesundheitswesen, A-1030 Vienna

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009