Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00239447
First received: October 14, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

Non-inferiority of lung function response to Tiotropium inhalation solution compared to Spiriva HandiHaler


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Device: HandiHaler
Device: Respimat SMI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough FEV1 response determined at the end of each 4-week period of randomised treatment. [ Time Frame: at the end of each 4-week period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tiotropium plasma concentration data and urinary excretion data [ Time Frame: at the end of each 4-week period ] [ Designated as safety issue: No ]
  • Trough forced vital capacity (FVC) response [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Peak response (FEV1 and FVC) [ Time Frame: within 3 hours after first dose, after 4 weeks ] [ Designated as safety issue: No ]
  • FEV1 AUC 0-12h and FVC AUC 0-12h response [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • FEV1 AUC 0-3h and FVC AUC 0-3h response [ Time Frame: after the first dose, after 4 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1and FVC measurements [ Time Frame: during study course of 28 weeks ] [ Designated as safety issue: No ]
  • pre-dose morning and evening peak expiratory flow rate (PEFR) [ Time Frame: during study course of 28 weeks ] [ Designated as safety issue: No ]
  • Number of occasions of rescue therapy used [ Time Frame: during study course of 28 weeks ] [ Designated as safety issue: No ]
  • Median time to onset of therapeutic response after first dose (FEV1) [ Time Frame: after first dose and after 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with 15% response above baseline for each treatment at each time point after first dose and after 4 weeks [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 131
Study Start Date: November 2002
Estimated Study Completion Date: April 2004
Primary Completion Date: April 2004 (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
  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: NCT00239447

Locations
United States, Arkansas
Division of Pulmonary and Critical Care Medicine
Little Rock, Arkansas, United States, 72205
United States, California
Boehringer Ingelheim Investigational Site
San Diego, California, United States, 92120
San Jose Clinical Research
San Jose, California, United States, 95128
Boehringer Ingelheim Investigational Site
Stockton, California, United States, 95207
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206-2762
United States, Louisiana
LSU MC-Sheveport
Shreveport, Louisiana, United States, 71103
United States, Minnesota
Minisota Lung Center
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Washington
Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States, 98405
Canada, Quebec
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec, Canada, H2X 2P4
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00239447     History of Changes
Other Study ID Numbers: 205.249
Study First Received: October 14, 2005
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 29, 2014