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

Boehringer Ingelheim logo

Boehringer Ingelheim

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Study type

Observational

Funder types

Industry

Identifiers

NCT00620516
205.337

Details and patient eligibility

About

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.

Full description

Study Design:

Enrollment

3,008 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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).

Trial contacts and locations

71

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Data sourced from clinicaltrials.gov

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