Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients
Effect of Tiotropium on Exercise Tolerance and Static and Dynamic Lung Volumes in COPD Patients (A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study)
1 other identifier
interventional
261
4 countries
28
Brief Summary
To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2003
CompletedFirst Submitted
Initial submission to the registry
January 9, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedDecember 1, 2023
November 1, 2023
2.2 years
January 9, 2006
November 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Endurance time during a constant work rate exercise test to symptom limitation
2 hours and 15 minutes after trial medication administration on Day 42
Secondary Outcomes (14)
Constant work rate exercise test to symptom limitation
8 hours post-dose after 6 weeks of treatment
Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale
6 weeks
Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC)
6 weeks
Evaluation of VE and VEcap during exercise (selected centers)
6 weeks
Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC
6 weeks
- +9 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients with a clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on American Thoracic Society (ATS) guidelines with:
- Relatively stable, moderate to severe airway obstruction with an Forced Expiratory Volume in One Second (FEV1) less than or equal to 65% of predicted normal (determined at Visit 1).
- Presence of lung hyperinflation as demonstrated by Functional Residual Capacity determined by body plethysmography (TGV(FRC)) greater than or equal to 120% of predicted normal (determined at Visit 1).
- Age greater or equal to 40 years and less than or equal to 75 years.
- A cigarette smoking history of more than ten pack-years. A pack-year was defined as the equivalent of smoking one pack of cigarettes per day for a year.
- Able to perform all specified procedures and able to maintain all necessary records during the study period as required in the protocol.
- Able to inhale the trial medication from the HandiHaler device.
You may not qualify if:
- Patients with a significant disease other than COPD. A significant disease was defined as a disease which, in the opinion of the investigator, may have put the patient at risk because of participation in the trial or may have influenced the results of the trial or the patient's ability to participate in the trial.
- Patients with Serum Glutamic Oxaloacetic Transaminase (SGOT) ≥1.5 x ULN (upper limit of normal range), Serum Glutamic Pyruvic Transaminase (SGPT) ≥1.5 x ULN bilirubin ≥1.5 x ULN or creatinine ≥1.5 x ULN were excluded regardless of the clinical condition.
- Patients with a recent history (i.e., 1 year or less) of myocardial infarction.
- Patients with a recent history (i.e., 3 years or less) of heart failure, pulmonary edema, or patients with cardiac arrhythmia (with or without symptoms) or any contraindication to exercise.
- Patients requiring the regular use of daytime oxygen therapy.
- Patients with known active tuberculosis.
- Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were eligible.
- Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
- Patients with an upper respiratory tract infection in the 6 weeks prior to the Screening Visit (Visit 1) or during the run-in period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
St. Elizabeth's Medical Center of Boston
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Thomas Health Services
Nashville, Tennessee, United States
Presbyterian Hospital of Dallas
Dallas, Texas, United States
Phase I Unit
Randwick, New South Wales, Australia
Immunology Department
Westmead, New South Wales, Australia
Department of Respiratory Medicine
Daw Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Department of Respiratory Medicine
Heidelberg, Victoria, Australia
Respiratory Research
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Respiratory Clinic
Vancouver, British Columbia, Canada
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Cardio Repiratory
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
1053 Carling Avenue
Ottawa, Ontario, Canada
Department of Respiratory Medicine
Toronto, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec, Canada
Pulmonary Function Lab
Montreal, Quebec, Canada
Hopital Laval
Ste-Foy, Quebec, Canada
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Klinikum der Universität zu Köln
Cologne, Germany
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
Hamburg, Germany
Fraunhofer-Institut für Toxikologie und
Hanover, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Neurologische Klinik der Otto-von-Guericke-Universität
Magdeburg, Germany
Boehringer Ingelheim Investigational Site
München, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2006
First Posted
January 11, 2006
Study Start
October 10, 2000
Primary Completion
January 7, 2003
Last Updated
December 1, 2023
Record last verified: 2023-11