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Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274547
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013

January 9, 2006
October 31, 2013
September 2001
February 2003   (final data collection date for primary outcome measure)
  • Percentage of patients experiencing an exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients hospitalized for a COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The co-primary endpoints were the proportion of patients experiencing an exacerbation of COPD and the proportion of patients hospitalized for a COPD exacerbation during the six month treatment period.
Complete list of historical versions of study NCT00274547 on ClinicalTrials.gov Archive Site
  • Time to first COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to first hospitalization associated with an COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total number of days of corticosteroids for an COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total number of antibiotics for an COPD exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of unscheduled out-patient visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total number of hospital admissions and total hospital days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Trough post-dose FEV1 and FVC [ Time Frame: after 3 and 6 months ] [ Designated as safety issue: No ]
  • 90 minute post-dose FEV1 and FVC [ Time Frame: after 3 and 6 months ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of exacerbations and related hospitalizations Time to first exacerbation and related hospitalization Mean # of days of antibiotics/steroids for exacerbations # of unscheduled visits for exacerbation Pulmonary function at study visits
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Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Proportion of Patients Experiencing an Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a Veterans Affairs Setting

The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1829
Not Provided
February 2003   (final data collection date for primary outcome measure)
Not Provided
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00274547
205.266
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP