Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00274508




Registration number
NCT00274508
Ethics application status
Date submitted
9/01/2006
Date registered
11/01/2006
Date last updated
1/12/2023

Titles & IDs
Public title
Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients
Scientific 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)
Secondary ID [1] 0 0
205.223
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Endurance time during a constant work rate exercise test to symptom limitation
Timepoint [1] 0 0
2 hours and 15 minutes after trial medication administration on Day 42
Secondary outcome [1] 0 0
Constant work rate exercise test to symptom limitation
Timepoint [1] 0 0
8 hours post-dose after 6 weeks of treatment
Secondary outcome [2] 0 0
Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC)
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
Evaluation of VE and VEcap during exercise (selected centers)
Timepoint [4] 0 0
6 weeks
Secondary outcome [5] 0 0
Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
Evaluation of TAC (TAV = TLC(BOX)-VA(IG))
Timepoint [6] 0 0
6 weeks
Secondary outcome [7] 0 0
Evaluation of slow vital capacity (SVC)
Timepoint [7] 0 0
6 weeks
Secondary outcome [8] 0 0
Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC
Timepoint [8] 0 0
6 weeks
Secondary outcome [9] 0 0
Evaluation of TGV, Raw, SGaw and RV
Timepoint [9] 0 0
6 weeks
Secondary outcome [10] 0 0
Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test
Timepoint [10] 0 0
6 weeks
Secondary outcome [11] 0 0
Physician's Global Assessment
Timepoint [11] 0 0
6 weeks
Secondary outcome [12] 0 0
Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise
Timepoint [12] 0 0
6 weeks
Secondary outcome [13] 0 0
Changes in Physical examination and ECG
Timepoint [13] 0 0
6 weeks
Secondary outcome [14] 0 0
Occurrence of Adverse Events
Timepoint [14] 0 0
6 weeks

Eligibility
Key inclusion 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.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
261
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Phase I Unit - Randwick
Recruitment hospital [2] 0 0
Immunology Department - Westmead
Recruitment hospital [3] 0 0
Department of Respiratory Medicine - Daw Park
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 0 0
Department of Respiratory Medicine - Heidelberg
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- Daw Park
Recruitment postcode(s) [4] 0 0
- Woodville
Recruitment postcode(s) [5] 0 0
- Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
British Columbia
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Saskatchewan
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
Hannover
Country [13] 0 0
Germany
State/province [13] 0 0
Kiel
Country [14] 0 0
Germany
State/province [14] 0 0
Köln
Country [15] 0 0
Germany
State/province [15] 0 0
Magdeburg
Country [16] 0 0
Germany
State/province [16] 0 0
München

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim Study Coordinator
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00274508