Special Survey Long-term Treatment With Tiotropium on COPD

Boehringer Ingelheim385 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

385

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (89)

Outcomes

Primary Outcomes

Number of Patients With Adverse Events (AEs)

Number of patients with AEs

Time frame: Pre treatment and 52 weeks after the treatment

Number of Patients With Adverse Drug Reactions (ADRs)

Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.

Time frame: Pre treatment and 52 weeks after the treatment

Secondary Outcomes

Effective Rate of Comprehensive Evaluation

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

Time frame: 52 weeks

Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks

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

Time frame: Pre treatment and 52 weeks after the treatment

Data from ClinicalTrials.gov

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