Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

January 13, 2016 updated by: Boehringer Ingelheim
The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

754

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

  • Austria
      • Admont, Austria
        • Boehringer Ingelheim Investigational Site
      • Afritz am See, Austria
        • Boehringer Ingelheim Investigational Site
      • Altenmarkt, Austria
        • Boehringer Ingelheim Investigational Site
      • Altmünster, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Gleichenberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Goisern, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Hall, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Häring, Austria
        • Boehringer Ingelheim Investigational Site
      • Bleiburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Bludenz, Austria
        • Boehringer Ingelheim Investigational Site
      • Brixlegg, Austria
        • Boehringer Ingelheim Investigational Site
      • Drasenhofen, Austria
        • Boehringer Ingelheim Investigational Site
      • Enns, Austria
        • Boehringer Ingelheim Investigational Site
      • Fohnsdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Gmunden, Austria
        • Boehringer Ingelheim Investigational Site
      • Grafenstein, Austria
        • Boehringer Ingelheim Investigational Site
      • Graz, Austria
        • Boehringer Ingelheim Investigational Site
      • Grünbach, Austria
        • Boehringer Ingelheim Investigational Site
      • Gunskirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Gutenstein, Austria
        • Boehringer Ingelheim Investigational Site
      • Gänserndorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Haid, Austria
        • Boehringer Ingelheim Investigational Site
      • Haid bei Ansfelden, Austria
        • Boehringer Ingelheim Investigational Site
      • Hainburg/a.d. Donau, Austria
        • Boehringer Ingelheim Investigational Site
      • Herzogenburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Hürm, Austria
        • Boehringer Ingelheim Investigational Site
      • Innsbruck, Austria
        • Boehringer Ingelheim Investigational Site
      • Jenbach, Austria
        • Boehringer Ingelheim Investigational Site
      • Judenburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Kindberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Kirchberg Wechsel, Austria
        • Boehringer Ingelheim Investigational Site
      • Klagenfurt, Austria
        • Boehringer Ingelheim Investigational Site
      • Klein-Pöchlarn, Austria
        • Boehringer Ingelheim Investigational Site
      • Knittelfeld, Austria
        • Boehringer Ingelheim Investigational Site
      • Kuchl, Austria
        • Boehringer Ingelheim Investigational Site
      • Königswiesen 132, Austria
        • Boehringer Ingelheim Investigational Site
      • Langenrohr, Austria
        • Boehringer Ingelheim Investigational Site
      • Lebring, Austria
        • Boehringer Ingelheim Investigational Site
      • Leobersdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Linz, Austria
        • Boehringer Ingelheim Investigational Site
      • Lustenau, Austria
        • Boehringer Ingelheim Investigational Site
      • Mank, Austria
        • Boehringer Ingelheim Investigational Site
      • Mödling, Austria
        • Boehringer Ingelheim Investigational Site
      • Neuberg/Mürz, Austria
        • Boehringer Ingelheim Investigational Site
      • Neumarkt a.W., Austria
        • Boehringer Ingelheim Investigational Site
      • Neunkirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Niederhollabrunn, Austria
        • Boehringer Ingelheim Investigational Site
      • Oberschützen, Austria
        • Boehringer Ingelheim Investigational Site
      • Ollersdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Passail, Austria
        • Boehringer Ingelheim Investigational Site
      • Peesen, Austria
        • Boehringer Ingelheim Investigational Site
      • Pfarrkirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Pichl bei Wels, Austria
        • Boehringer Ingelheim Investigational Site
      • Pischeldorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Rattenberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Salzburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Schwechat, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Johann, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Stefan o Stainz, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Valentin, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Veit Glan, Austria
        • Boehringer Ingelheim Investigational Site
      • St.Georgen/Judenburg 12, Austria
        • Boehringer Ingelheim Investigational Site
      • Stainach, Austria
        • Boehringer Ingelheim Investigational Site
      • Stasshof, Austria
        • Boehringer Ingelheim Investigational Site
      • Traismauer, Austria
        • Boehringer Ingelheim Investigational Site
      • Tulln, Austria
        • Boehringer Ingelheim Investigational Site
      • Vöcklabruck, Austria
        • Boehringer Ingelheim Investigational Site
      • Wallern an der Trattnach, Austria
        • Boehringer Ingelheim Investigational Site
      • Weiz, Austria
        • Boehringer Ingelheim Investigational Site
      • Weißtrach, Austria
        • Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site
      • Wilhelmsburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Wolfsberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Wolkersdorf, Austria
        • 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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

primary care

Description

Inclusion Criteria:

  • Patients with suspected chronic obstructive pulmonary disease (COPD)
  • 3 or more positive answers in COPD questionnaire
  • Age over 40 years

Exclusion Criteria:

  • Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
  • Patient treated with Spiriva in the past year
  • Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics

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
Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva
Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva
Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Efficacy by Patient
Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Tolerability by Patient
Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Efficacy by Physician
Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Tolerability by Physician
Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

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, 2007

Primary Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.398

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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