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
  Purpose

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.


Condition Intervention Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough FEV1 response after 12 weeks of treatment. [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 491
Study Start Date: November 2002
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240435

  Show 25 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00240435     History of Changes
Other Study ID Numbers: 205.252
Study First Received: October 14, 2005
Last Updated: October 31, 2013
Health Authority: Unspecified

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Ipratropium
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics

ClinicalTrials.gov processed this record on July 20, 2014