Special Survey Long-term Treatment With Tiotropium on COPD

June 18, 2014 updated by: Boehringer Ingelheim

Special Survey Long-term Treatment

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Asahikawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Chikushino, Japan
        • Boehringer Ingelheim Investigational Site
      • Daito, Japan
        • Boehringer Ingelheim Investigational Site
      • Ebina, Japan
        • Boehringer Ingelheim Investigational Site
      • Echizen, Japan
        • Boehringer Ingelheim Investigational Site
      • Fukui, Japan
        • Boehringer Ingelheim Investigational Site
      • Fukushima, Japan
        • Boehringer Ingelheim Investigational Site
      • Funabashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Gosen, Japan
        • Boehringer Ingelheim Investigational Site
      • Habikino, Japan
        • Boehringer Ingelheim Investigational Site
      • Hakodate, Japan
        • Boehringer Ingelheim Investigational Site
      • Hayashimacho, Japan
        • Boehringer Ingelheim Investigational Site
      • Higashiosakaka, Japan
        • Boehringer Ingelheim Investigational Site
      • Himeji, Japan
        • Boehringer Ingelheim Investigational Site
      • Hirosaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Hiroshima, Japan
        • Boehringer Ingelheim Investigational Site
      • Hitachi, Japan
        • Boehringer Ingelheim Investigational Site
      • Iizuka, Japan
        • Boehringer Ingelheim Investigational Site
      • Ikoma, Japan
        • Boehringer Ingelheim Investigational Site
      • Ishinomaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Itanocho, Japan
        • Boehringer Ingelheim Investigational Site
      • Kasukabe, Japan
        • Boehringer Ingelheim Investigational Site
      • Katsuragicho, Japan
        • Boehringer Ingelheim Investigational Site
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Kishiwada, Japan
        • Boehringer Ingelheim Investigational Site
      • Kitakyushu, Japan
        • Boehringer Ingelheim Investigational Site
      • Kobayashi, Japan
        • Boehringer Ingelheim Investigational Site
      • Koga, Japan
        • Boehringer Ingelheim Investigational Site
      • Komaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Komatsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Koshu, Japan
        • Boehringer Ingelheim Investigational Site
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site
      • Kunimicho, Japan
        • Boehringer Ingelheim Investigational Site
      • Kyotango, Japan
        • Boehringer Ingelheim Investigational Site
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site
      • Matsudo, Japan
        • Boehringer Ingelheim Investigational Site
      • Matsue, Japan
        • Boehringer Ingelheim Investigational Site
      • Matsumoto, Japan
        • Boehringer Ingelheim Investigational Site
      • Mihamacho, Japan
        • Boehringer Ingelheim Investigational Site
      • Minamiuonuma, Japan
        • Boehringer Ingelheim Investigational Site
      • Mishima, Japan
        • Boehringer Ingelheim Investigational Site
      • Mizumakimachi, Japan
        • Boehringer Ingelheim Investigational Site
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagaoka, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagasaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site
      • Nichinan, Japan
        • Boehringer Ingelheim Investigational Site
      • Niihama, Japan
        • Boehringer Ingelheim Investigational Site
      • Nogata, Japan
        • Boehringer Ingelheim Investigational Site
      • Numata, Japan
        • Boehringer Ingelheim Investigational Site
      • Obihiro, Japan
        • Boehringer Ingelheim Investigational Site
      • Obu, Japan
        • Boehringer Ingelheim Investigational Site
      • Odawara, Japan
        • Boehringer Ingelheim Investigational Site
      • Ogaki, Japan
        • Boehringer Ingelheim Investigational Site
      • Okuchi, Japan
        • Boehringer Ingelheim Investigational Site
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site
      • Otsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Saiki, Japan
        • Boehringer Ingelheim Investigational Site
      • Saitama, Japan
        • Boehringer Ingelheim Investigational Site
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site
      • Sakede, Japan
        • Boehringer Ingelheim Investigational Site
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site
      • Sayama, Japan
        • Boehringer Ingelheim Investigational Site
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site
      • Shiroishi, Japan
        • Boehringer Ingelheim Investigational Site
      • Shiroishicho, Japan
        • Boehringer Ingelheim Investigational Site
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site
      • Tagawa, Japan
        • Boehringer Ingelheim Investigational Site
      • Takarazuka, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Chiyoda-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Higashiyamato, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Itabashi-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Kita-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Koto-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Meguro-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Otaku-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tokyo Shinjuku-ku, Japan
        • Boehringer Ingelheim Investigational Site
      • Tsu, Japan
        • Boehringer Ingelheim Investigational Site
      • Tsukuba, Japan
        • Boehringer Ingelheim Investigational Site
      • Ube, Japan
        • Boehringer Ingelheim Investigational Site
      • Uji, Japan
        • Boehringer Ingelheim Investigational Site
      • Urayasu, Japan
        • Boehringer Ingelheim Investigational Site
      • Uruma, Japan
        • Boehringer Ingelheim Investigational Site
      • Utsunomiya, Japan
        • Boehringer Ingelheim Investigational Site
      • Yamagata, Japan
        • Boehringer Ingelheim Investigational Site
      • Yame, Japan
        • Boehringer Ingelheim Investigational Site
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site
      • Yorocho, Japan
        • Boehringer Ingelheim Investigational Site
      • Yurihonjo, Japan
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

COHORT

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Adverse Events (AEs)
Time Frame: Pre treatment and 52 weeks after the treatment
Number of patients with AEs
Pre treatment and 52 weeks after the treatment
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.
Pre treatment and 52 weeks after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
52 weeks
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
Pre treatment and 52 weeks after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 19, 2014

Last Update Submitted That Met QC Criteria

June 18, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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