Special Survey Long-term Treatment With Tiotropium on COPD
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|ClinicalTrials.gov Identifier: NCT00638183|
Recruitment Status : Completed
First Posted : March 18, 2008
Results First Posted : April 5, 2010
Last Update Posted : June 19, 2014
|Condition or disease|
|Pulmonary Disease, Chronic Obstructive|
|Study Type :||Observational|
|Actual Enrollment :||385 participants|
|Official Title:||Special Survey Long-term Treatment|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||January 2009|
- Number of Patients With Adverse Events (AEs) [ Time Frame: Pre treatment and 52 weeks after the treatment ]Number of patients with AEs
- Number of Patients With Adverse Drug Reactions (ADRs) [ Time Frame: 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.
- Effective Rate of Comprehensive Evaluation [ Time Frame: 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 [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638183
Show 89 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|