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

Tracking Information

First Received Date ^ICMJE

February 4, 2008

Last Updated Date

October 29, 2009

Start Date ^ICMJE

July 2005

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 Spirivaâ 18¿g inhalation capsule. [ Time Frame: 30days ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00620516 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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: 30days ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients

Official Title ^ICMJE

Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients: A 30 Day, Open-Label, Post-marketing Study

Brief Summary

This is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18mcg 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 18mcg 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.

Detailed Description

Study Design:

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Other, Prospective

Condition ^ICMJE

Pulmonary Disease, Chronic Obstructive

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3021

Completion Date

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00620516

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

205.337

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP