Special Survey Long-term Treatment With Tiotropium on COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00638183
First received: March 11, 2008
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Survey Long-term Treatment

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 385
Study Start Date: April 2005
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

COHORT

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638183

  Show 89 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00638183     History of Changes
Other Study ID Numbers: 205.315
Study First Received: March 11, 2008
Results First Received: January 19, 2010
Last Updated: June 18, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on July 20, 2014