Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00620516

Purpose

This is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18μg once a day for 30 days among Korean patients with COPD. At Visit 1, patients who are diagnosed as COPD will be prescribed tiotropium inhalation capsule at 18μg once daily (at the same time). Patients' FEV1 will be assessed before start of treatment (Visit 1) and at the end of the 30 day treatment period (Visit 2). Occurrence of adverse events will also be asked from the patient at the end of the 30 day treatment period. Patients will be informed by the attending physicians to immediately report the occurrence of serious adverse events.

Condition	Phase
COPD	Phase IV

Drug Information available for: Tiotropium Tiotropium bromide

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Safety and Efficacy of Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients: A 30 Day, Open-Label, Post-Marketing Study

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint for this postmarking study is the occurrence of adverse events, anytime during the 30 day study period, which might or might not be connected with the use of Spiriva 18μg inhalation capsule. [ Time Frame: 30 days ]

Secondary Outcome Measures:

Secondary endpoints include change in post-bronchodilator FEV1 and assessment of any change in overall severity of the disease from baseline to the end of 30-day treatment. [ Time Frame: 30 days ]

Estimated Enrollment:	3000
Estimated Study Completion Date:	August 2010

Eligibility

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

Criteria

INCLUSION CRITERIA:

Older than 40 years old
Diagnosed as COPD
No Previous Spiriva administration
No Contraindication for Spiriva according to the product label

EXCLUSION CRITERIA:

patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620516

Locations

Korea, Republic of
Boehringer Ingelheim
Seoul, Korea, Republic of
Boehringer Ingelheim
Gyeonggido, Korea, Republic of
Boehringer Ingelheim
Daegu, Korea, Republic of
Boehringer Ingelheim
Busan, Korea, Republic of
Boehringer Ingelheim
Ulsan, Korea, Republic of
Boehringer Ingelheim
Incheon, Korea, Republic of
Boehringer Ingelheim
Daejeon, Korea, Republic of
Boehringer Ingelheim
Chugnam, Korea, Republic of
Boehringer Ingelheim
Jeonnam, Korea, Republic of
Boehringer Ingelheim
Gangwondo, Korea, Republic of
Boehringer Ingelheim
Jeonbuk, Korea, Republic of

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

B.I. Korea Ltd.

More Information

Study ID Numbers:	205.337
Study First Received:	February 4, 2008
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00620516
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

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

ClinicalTrials.gov processed this record on January 16, 2009