Special Survey Long-term Treatment With Tiotropium on COPD
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.
Pulmonary Disease, Chronic Obstructive
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Special Survey Long-term Treatment|
- Effective Rate of Comprehensive Evaluation [ Time Frame: 52 weeks ]
Evaluate from improvement FEV1.0 (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 FEV1.0 and symptoms. The effective rate was derived from rate of "Improvement" in total number of analyzed patients
- Forced Expiratory Volume (L) in 1 Second [ Time Frame: 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
|Study Start Date:||April 2005|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim Pharmaceuticals|