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

NCT ID: NCT00274508

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-10

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

tiotropium bromide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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 clinically significant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defined a disease listed as an exclusion criterion, the patient was excluded.
• 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 who had undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons were evaluated as per the first exclusion criterion (i.e., significant disease other than COPD).
• Patients with an upper respiratory tract infection in the 6 weeks prior to the Screening Visit (Visit 1) or during the run-in period.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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

Countries

United States; Australia; Canada; Germany

Other Identifiers

205.223

Identifier Type: -

Identifier Source: org_study_id