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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)

NCT00274508•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

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).
+1 more criteria

Locations (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

Key Dates

Start Date

October 10, 2000

Primary Completion Date

January 7, 2003

Last Updated

December 1, 2023

Enrollment

261

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium bromide

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

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RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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