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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274508
• Other study ID #: 205.223
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2000

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. primary completion date: January 7, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

• Further exclusion criteria apply.

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• tiotropium bromide

Locations

Country	Name	City	State
Australia	Department of Respiratory Medicine	Daw Park	South Australia
Australia	Department of Respiratory Medicine	Heidelberg	Victoria
Australia	Phase I Unit	Randwick	New South Wales
Australia	Immunology Department	Westmead	New South Wales
Australia	The Queen Elizabeth Hospital	Woodville	South Australia
Canada	Respiratory Research	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia
Canada	Cardio Repiratory	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Montreal Chest Institute - McGill University Health Centre	Montreal	Quebec
Canada	Pulmonary Function Lab	Montreal	Quebec
Canada	1053 Carling Avenue	Ottawa	Ontario
Canada	Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	Hopital Laval	Ste-Foy	Quebec
Canada	Department of Respiratory Medicine	Toronto	Ontario
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario
Canada	Respiratory Clinic	Vancouver	British Columbia
Germany	Pneumologisches Forschungsinstitut GmbH am Krankenhaus	Hamburg
Germany	Fraunhofer-Institut für Toxikologie und	Hannover
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Klinikum der Universität zu Köln	Köln
Germany	Neurologische Klinik der Otto-von-Guericke-Universität	Magdeburg
Germany	Boehringer Ingelheim Investigational Site	München
United States	St. Elizabeth's Medical Center of Boston	Boston	Massachusetts
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	St. Thomas Health Services	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Constant work rate exercise test to symptom limitation		8 hours post-dose after 6 weeks of treatment
Secondary	Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale		6 weeks
Secondary	Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC)		6 weeks
Secondary	Evaluation of VE and VEcap during exercise (selected centers)		6 weeks
Secondary	Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC		6 weeks
Secondary	Evaluation of TAC (TAV = TLC(BOX)-VA(IG))		6 weeks
Secondary	Evaluation of slow vital capacity (SVC)		6 weeks
Secondary	Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC		6 weeks
Secondary	Evaluation of TGV, Raw, SGaw and RV		6 weeks
Secondary	Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test		6 weeks
Secondary	Physician's Global Assessment		6 weeks
Secondary	Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise		6 weeks
Secondary	Changes in Physical examination and ECG		6 weeks
Secondary	Occurrence of Adverse Events		6 weeks