MedDataX Logo

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

NCT ID: NCT02172560

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

441 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Premature withdrawal from tiotropium

Tiotropium

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tiotropium

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Not applicable.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boehringer Ingelheim Investigational Site 61501

Garran, Australian Capital Territory, Australia

Site Status

Boehringer Ingelheim Investigational Site 61403

Clayton, New South Wales, Australia

Site Status

Boehringer Ingelheim Investigational Site 61502

Adelaide, South Australia, Australia

Site Status

Boehringer Ingelheim Investigational Site 61401

Woodsville South, South Australia, Australia

Site Status

Boehringer Ingelheim Investigational Site 61402

Frankston, Victoria, Australia

Site Status

Boehringer Ingelheim Investigational Site 61503

Nedlands, Western Australia, Australia

Site Status

Boehringer Ingelheim Investigational Site 61405

Perth, Western Australia, Australia

Site Status

Boehringer Ingelheim Investigational Site 61505

Hamilton, , New Zealand

Site Status

Boehringer Ingelheim Investigational Site 61504

Otahuhu, , New Zealand

Site Status

Boehringer Ingelheim Investigational Site 44402

Birmingham, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site 44409

Bristol, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site 44502

Devon, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site 44504

Hull, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site 44507

Isleworth, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site 44506

Manchester, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site 44403

Nottingham, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site 44405

Swansea, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site 44404

Torquay, , United Kingdom

Site Status

Boehringer Ingelheim Investigational Site 44505

Torquay, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia New Zealand United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

205.392

Identifier Type: -

Identifier Source: org_study_id