A Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Tiotropium Inhalation Solution Delivered by the Respimat Inhaler

November 17, 2014 updated by: Boehringer Ingelheim

A Retrospective Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Either of Two One-Year Trials (205.254, 205.255) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler

The objectives were to collect information on vital status and pulmonary medication use at the predicted exit date for patients who participated in two one-year trials and withdrew prematurely. The primary objective was to ascertain the vital status (dead or alive) of these patients in the time interval between the patients' withdrawal from the trial and their predicted exit date (i.e: 48 weeks from first intake of randomised treatment + 30 days). The secondary objective was to collect information on classes of pulmonary medication and some other specified pulmonary interventions used by these prematurely discontinued patients at the time of their predicted exit date (i.e 48 weeks from the first intake of randomised treatment + 30 days) or at date of death (if this occurred during the time interval of interest, i.e 48 weeks from the first intake of randomised treatment + 30 days).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

441

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

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia
        • Boehringer Ingelheim Investigational Site 61501
    • New South Wales
      • Clayton, New South Wales, Australia
        • Boehringer Ingelheim Investigational Site 61403
    • South Australia
      • Adelaide, South Australia, Australia
        • Boehringer Ingelheim Investigational Site 61502
      • Woodsville South, South Australia, Australia
        • Boehringer Ingelheim Investigational Site 61401
    • Victoria
      • Frankston, Victoria, Australia
        • Boehringer Ingelheim Investigational Site 61402
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Boehringer Ingelheim Investigational Site 61503
      • Perth, Western Australia, Australia
        • Boehringer Ingelheim Investigational Site 61405
  • New Zealand
      • Hamilton, New Zealand
        • Boehringer Ingelheim Investigational Site 61505
      • Otahuhu, New Zealand
        • Boehringer Ingelheim Investigational Site 61504
  • United Kingdom
      • Birmingham, United Kingdom
        • Boehringer Ingelheim Investigational Site 44402
      • Bristol, United Kingdom
        • Boehringer Ingelheim Investigational Site 44409
      • Devon, United Kingdom
        • Boehringer Ingelheim Investigational Site 44502
      • Hull, United Kingdom
        • Boehringer Ingelheim Investigational Site 44504
      • Isleworth, United Kingdom
        • Boehringer Ingelheim Investigational Site 44507
      • Manchester, United Kingdom
        • Boehringer Ingelheim Investigational Site 44506
      • Nottingham, United Kingdom
        • Boehringer Ingelheim Investigational Site 44403
      • Swansea, United Kingdom
        • Boehringer Ingelheim Investigational Site 44405
      • Torquay, United Kingdom
        • Boehringer Ingelheim Investigational Site 44404
      • Torquay, United Kingdom
        • Boehringer Ingelheim Investigational Site 44505

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with COPD who withdrew prematurely from the randomised treatment phases of studies 205.254 and 205.255

Description

Inclusion Criteria:

  • Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.

Exclusion Criteria:

  • Not applicable.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Premature withdrawal from tiotropium
Drug: Tiotropium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and status of patients dead or alive at the predicted end of treatment date
Time Frame: Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death

Secondary Outcome Measures

Outcome Measure
Time Frame
Number and specification of patients on pulmonary medications and other pulmonary interventions
Time Frame: Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death

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

March 1, 2007

Primary Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (ESTIMATE)

June 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.392

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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