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. Identifier: NCT00638183
Recruitment Status : Completed
First Posted : March 18, 2008
Results First Posted : April 5, 2010
Last Update Posted : June 19, 2014
Information provided by:
Boehringer Ingelheim

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.

Condition or disease
Pulmonary Disease, Chronic Obstructive

Study Type : Observational
Actual Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Survey Long-term Treatment
Study Start Date : April 2005
Primary Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

Primary Outcome Measures :
  1. Number of Patients With Adverse Events (AEs) [ Time Frame: Pre treatment and 52 weeks after the treatment ]
    Number of patients with AEs

  2. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00638183

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00638183     History of Changes
Other Study ID Numbers: 205.315
First Posted: March 18, 2008    Key Record Dates
Results First Posted: April 5, 2010
Last Update Posted: June 19, 2014
Last Verified: June 2014

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