12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00240435
First received: October 14, 2005
Last updated: October 31, 2013
Last verified: October 2013

October 14, 2005
October 31, 2013
November 2002
December 2003   (final data collection date for primary outcome measure)
Trough FEV1 response after 12 weeks of treatment. [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
FEV1 (trough, AUC 0-6h; peak, onset and duration of response; percent responders), FVC (trough, AUC 0-6h, peak), twice daily PEFR, rescue medication use, COPD symptoms, global evaluations
Complete list of historical versions of study NCT00240435 on ClinicalTrials.gov Archive Site
  • Trough FEV1 response [ Time Frame: after 1, 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Trough FVC response [ Time Frame: after 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • FEV1 and FVC area under the curve and peak response [ Time Frame: after 0, 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1 and FVC measurements at each time point [ Time Frame: during study course of 12 weeks ] [ Designated as safety issue: No ]
  • Therapeutic response and percentage of responders [ Time Frame: after 0 and 12 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pre-dose morning and evening PEFR [ Time Frame: during study course of 12 weeks ] [ Designated as safety issue: No ]
  • Number of occasions of rescue therapy used per day (PRN salbutamol) [ Time Frame: during study course of 12 weeks ] [ Designated as safety issue: No ]
  • COPD symptom scores [ Time Frame: during 15 weeks ] [ Designated as safety issue: No ]
  • Physician's Global Evaluation [ Time Frame: during 15 weeks ] [ Designated as safety issue: No ]
  • Number of patients with at least one exacerbation of COPD [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • time to first exacerbation [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • number of exacerbations [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • number of exacerbation days [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction and preference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: during 15 weeks, follow-up period included ] [ Designated as safety issue: No ]
  • Pulse rate and blood pressure for the first three hours following dosing [ Time Frame: after 0, 1, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Routine blood chemistry, haematology and urinalysis [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • 12-lead ECG [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
Adverse events, vital signs, laboratory evaluations, ECG testing and physical examinations
Not Provided
Not Provided
 
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Device: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
  • Device: 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
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
491
Not Provided
December 2003   (final data collection date for primary outcome measure)

Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00240435
205.252
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