Special Survey Long-term Treatment With Tiotropium on COPD
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|