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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

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ClinicalTrials.gov Identifier: NCT02172560
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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).

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium

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Study Type : Observational
Actual Enrollment : 441 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Study Start Date : March 2007
Actual Primary Completion Date : January 2008

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with COPD who withdrew prematurely from the randomised treatment phases of studies 205.254 and 205.255
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not applicable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172560


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172560    
Other Study ID Numbers: 205.392
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action