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NCT02172560 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02172560
Other study ID # 205.392
Secondary ID
Status Completed
Phase N/A
First received June 20, 2014
Last updated November 17, 2014
Start date March 2007

Study information
Verified date June 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research CouncilAustria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Public Health Agency of CanadaFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesIreland: Irish Medicines BoardNew Zealand: Ministry of HealthNorway: Norwegian Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSouth Africa: Medicines Control CouncilSweden: Medical Products AgencyTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationFrance: Ministry of HealthGreece: Ministry of Health and WelfareItaly: Ministry of HealthNetherlands: Ministry of Health, Welfare and SportSpain: Ministry of Health
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 441
Est. completion date
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Tiotropium

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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Australia,  New Zealand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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