NCT02172560

Brief Summary

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).

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
441

participants targeted

Target at P75+ for all trials

Geographic Reach
3 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

November 18, 2014

Status Verified

June 1, 2014

Enrollment Period

10 months

First QC Date

June 20, 2014

Last Update Submit

November 17, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Number and status of patients dead or alive at the predicted end of treatment date

    Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death

Secondary Outcomes (1)

  • Number and specification of patients on pulmonary medications and other pulmonary interventions

    Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death

Study Arms (1)

Premature withdrawal from tiotropium

Drug: Tiotropium

Interventions

TiotropiumDRUG
Premature withdrawal from tiotropium

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Boehringer Ingelheim Investigational Site 61501

Garran, Australian Capital Territory, Australia

Location

Boehringer Ingelheim Investigational Site 61403

Clayton, New South Wales, Australia

Location

Boehringer Ingelheim Investigational Site 61502

Adelaide, South Australia, Australia

Location

Boehringer Ingelheim Investigational Site 61401

Woodsville South, South Australia, Australia

Location

Boehringer Ingelheim Investigational Site 61402

Frankston, Victoria, Australia

Location

Boehringer Ingelheim Investigational Site 61503

Nedlands, Western Australia, Australia

Location

Boehringer Ingelheim Investigational Site 61405

Perth, Western Australia, Australia

Location

Boehringer Ingelheim Investigational Site 61505

Hamilton, New Zealand

Location

Boehringer Ingelheim Investigational Site 61504

Otahuhu, New Zealand

Location

Boehringer Ingelheim Investigational Site 44402

Birmingham, United Kingdom

Location

Boehringer Ingelheim Investigational Site 44409

Bristol, United Kingdom

Location

Boehringer Ingelheim Investigational Site 44502

Devon, United Kingdom

Location

Boehringer Ingelheim Investigational Site 44504

Hull, United Kingdom

Location

Boehringer Ingelheim Investigational Site 44507

Isleworth, United Kingdom

Location

Boehringer Ingelheim Investigational Site 44506

Manchester, United Kingdom

Location

Boehringer Ingelheim Investigational Site 44403

Nottingham, United Kingdom

Location

Boehringer Ingelheim Investigational Site 44405

Swansea, United Kingdom

Location

Boehringer Ingelheim Investigational Site 44404

Torquay, United Kingdom

Location

Boehringer Ingelheim Investigational Site 44505

Torquay, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 24, 2014

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Last Updated

November 18, 2014

Record last verified: 2014-06

Locations

GB(10)NZ(2)AU(7)