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Special Survey Long-term Treatment With Tiotropium on COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00638183
Recruitment Status : Completed
First Posted : March 18, 2008
Results First Posted : April 5, 2010
Last Update Posted : June 19, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date March 11, 2008
First Posted Date March 18, 2008
Results First Submitted Date January 19, 2010
Results First Posted Date April 5, 2010
Last Update Posted Date June 19, 2014
Study Start Date April 2005
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2014)
  • 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.
Original Primary Outcome Measures
 (submitted: March 17, 2008)
Adverse event that developed after initiation of treatment with this product (adverse reaction/infection and abnormal laboratory findings), symptoms, onset date, seriousness, outcome, causal relationship with this product [ Time Frame: Safety : as needed; Efficacy : 1 year ]
Change History Complete list of historical versions of study NCT00638183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 18, 2014)
  • 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Survey Long-term Treatment With Tiotropium on COPD
Official Title Special Survey Long-term Treatment
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population COHORT
Condition Pulmonary Disease, Chronic Obstructive
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 16, 2009)
385
Original Enrollment
 (submitted: March 17, 2008)
300
Study Completion Date Not Provided
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00638183
Other Study ID Numbers 205.315
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date June 2014