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 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.

Condition
Pulmonary Disease, Chronic Obstructive

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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide Tiotropium

U.S. FDA Resources

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

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: 30days ]

Estimated Enrollment:	3000
Study Start Date:	July 2005
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Detailed Description:

Study Design:

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

3227

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

Show 71 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	205.337
Study First Received:	February 4, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00620516 History of Changes
Health Authority:	Korea, Republic of: Korea Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Lung Diseases, Obstructive
Cholinergic Antagonists
Respiratory Tract Diseases
Lung Diseases
Anti-Asthmatic Agents

Chronic Disease
Peripheral Nervous System Agents
Cholinergic Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Pathologic Processes
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 04, 2009