Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: tiotropium bromide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD

Official title: Effect of Tiotropium on Exercise Tolerance and Static and Dynamic Lung Volumes in COPD Patients (A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome: Evaluation of constant work rate exercise endurance (as measured by endurance time during a constant work rate exercise test to symptom limitation, 2 hours 15 minutes post-dose after 6 weeks of treatment)

Secondary outcome: Evaluation of dyspnea during constant work rate exercise test as measured by the modified Borg Scale; evaluation of static and dynamic lung hyperinflation as determined by inspiratory capacity (IC) at rest and during exercise

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

Pneumologisches Forschungsinstitut GmbH am Krankenhaus, Hamburg, Germany

Fraunhofer-Institut für Toxikologie und, Hannover, Germany

Universitätsklinikum Schleswig-Holstein, Kiel, Germany

Neurologische Klinik der Otto-von-Guericke-Universität, Magdeburg, Germany

Boehringer Ingelheim Investigational Site, München, Germany

Klinikum der Universität zu Köln, Köln, Germany

Respiratory Research, Calgary, Alberta, Canada

University of Alberta, Edmonton, Alberta, Canada

Respiratory Clinic, Vancouver, British Columbia, Canada

St. Elizabeth's Medical Center of Boston, Boston, Massachusetts, United States

Mayo Clinic, Rochester, Minnesota, United States

Immunology Department, Westmead, New South Wales, Australia

Phase I Unit, RANDWICK, New South Wales, Australia

Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada

1053 Carling Avenue, Ottawa, Ontario, Canada

Department of Respiratory Medicine, Toronto, Ontario, Canada

University Health Network - Toronto General Hospital, Toronto, Ontario, Canada

Cardio Repiratory, Hamilton, Ontario, Canada

Kingston General Hospital, Kingston, Ontario, Canada

Hopital Laval, Ste-Foy, Quebec, Canada

Montreal Chest Institute - McGill University Health Centre, Montreal, Quebec, Canada

Pulmonary Function Lab, Montreal, Quebec, Canada

Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada

Department of Respiratory Medicine, DAW PARK, South Australia, Australia

The Queen Elizabeth Hospital, WOODVILLE, South Australia, Australia

St. Thomas Health Services, Nashville, Tennessee, United States

Presbyterian Hospital of Dallas, Dallas, Texas, United States

Department of Respiratory Medicine, Heidelberg, Victoria, Australia

Starting date: October 2000
Ending date: April 2004
Last updated: April 2, 2008