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|
- Number of Patients With Adverse Events (AEs) [ Time Frame: Pre treatment and 52 weeks after the treatment ] [ Designated as safety issue: No ]Number of patients with AEs
- Number of Patients With Adverse Drug Reactions (ADRs) [ Time Frame: Pre treatment and 52 weeks after the treatment ] [ Designated as safety issue: No ]Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.
- Effective Rate of Comprehensive Evaluation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Pre treatment and 52 weeks after the treatment ] [ Designated as safety issue: No ]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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638183
Show 89 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|