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

Regulatory Requisite Post Marketing Surveillance to Assess the Safety and Efficacy of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder 18mcg, q.d.) in Korean COPD Patients: A 30-Day, Open Label, Non-interventional Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00620516

Enrollment

3008

Registered

2008-02-21

Start date

2004-03-31

Completion date

Unknown

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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:

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
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® 18 mcg inhalation capsule	30 days

Secondary

Measure	Time frame
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.	30 days

Countries

South Korea

Outcome results