Special Survey Long-term Treatment With Tiotropium on COPD

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00638183
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and effectiveness information on the use of this product for long period of time in daily clinical settings, and to obtain proper drug use information.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-18
• Primary Completion: 2009-01
• Results First Submitted: 2010-01-19
• Results First Submitted QC: 2010-03-23
• Results First Posted: 2010-04-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

1. Patients of Chronic Obstructive Pulmonary Disease
2. Patients were expected to use the product for long period of time

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Exclusion Criteria

1. Patients with glaucoma
2. Patients with micturition disorder due to prostatic hyperplasia etc.
3. Patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events (AEs)	Pre treatment and 52 weeks after the treatment	Number of patients with AEs
Number of Patients With Adverse Drug Reactions (ADRs)	Pre treatment and 52 weeks after the treatment	Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.

Secondary Outcome Measures

Name	Time	Method
Effective Rate of Comprehensive Evaluation	52 weeks	Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator.; Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided "comprehensive evaluation".; "comprehensive evaluation" was classified into 3 category, "improve" "No change+Aggravated" and "Unassessable" by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of "Improvement" in total number of analyzed patients
Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks	Pre treatment and 52 weeks after the treatment	Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇯🇵 Yurihonjo, Japan