Pulmonary Disease, Chronic ObstructivePhase 3NCT00274508
Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients
A Phase 3 study testing tiotropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 28 sites in 4 countries.
Trial summary
To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- tiotropium bromide
- How many people
- 261 participants
- Where
- 28 sitesin 4 countries
- Study dates
- 10 Oct 2000to 7 Jan 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
28 sites in 4 countries.
28 sites in 4 countries
Canada13 sites
Respiratory Research
Calgary, Alberta
University of Alberta
Edmonton, Alberta
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
Cardio Repiratory
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec
Pulmonary Function Lab
Montreal, Quebec
1053 Carling Avenue
Ottawa, Ontario
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
Hopital Laval
Ste-Foy, Quebec
Department of Respiratory Medicine
Toronto, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario
Respiratory Clinic
Vancouver, British Columbia
Germany6 sites
Klinikum der Universität zu Köln
Cologne
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
Hamburg
Fraunhofer-Institut für Toxikologie und
Hanover
Universitätsklinikum Schleswig-Holstein
Kiel
Neurologische Klinik der Otto-von-Guericke-Universität
Magdeburg
Boehringer Ingelheim Investigational Site
München
Australia5 sites
Department of Respiratory Medicine
Daw Park, South Australia
Department of Respiratory Medicine
Heidelberg, Victoria
Phase I Unit
Randwick, New South Wales
Immunology Department
Westmead, New South Wales
The Queen Elizabeth Hospital
Woodville, South Australia
United States4 sites
St. Elizabeth's Medical Center of Boston
Boston, Massachusetts
Presbyterian Hospital of Dallas
Dallas, Texas
St. Thomas Health Services
Nashville, Tennessee
Mayo Clinic
Rochester, Minnesota
About this study
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)
To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium bromide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropium bromideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time during a constant work rate exercise test to symptom limitation
Measured: 2 hours and 15 minutes after trial medication administration on Day 42
Secondary outcomes (14)
Constant work rate exercise test to symptom limitation
Measured: 8 hours post-dose after 6 weeks of treatment
Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale
Measured: 6 weeks
Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC)
Measured: 6 weeks
Evaluation of VE and VEcap during exercise (selected centers)
Measured: 6 weeks
Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC
Measured: 6 weeks
Evaluation of TAC (TAV = TLC(BOX)-VA(IG))
Measured: 6 weeks
Evaluation of slow vital capacity (SVC)
Measured: 6 weeks
Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC
Measured: 6 weeks
Evaluation of TGV, Raw, SGaw and RV
Measured: 6 weeks
Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test
Measured: 6 weeks
Physician's Global Assessment
Measured: 6 weeks
Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise
Measured: 6 weeks
Changes in Physical examination and ECG
Measured: 6 weeks
Occurrence of Adverse Events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study start10 Oct 2000
- Primary completion7 Jan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274508
- Sponsor's protocol ID
- 205.223
- Status last verified
- Nov 2023
- First submitted
- 9 Jan 2006
- Last updated
- 1 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00274508
- Acronym / sponsor ID
- 205.223
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2000 (actual)
- Primary completion
- 7 Jan 2003 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tiotropium bromide | Drug | – |
Primary outcome
Endurance time during a constant work rate exercise test to symptom limitation
Time frame: 2 hours and 15 minutes after trial medication administration on Day 42
14 secondary outcomes
Constant work rate exercise test to symptom limitation
Time frame: 8 hours post-dose after 6 weeks of treatment
Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale
Time frame: 6 weeks
Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC)
Time frame: 6 weeks
Evaluation of VE and VEcap during exercise (selected centers)
Time frame: 6 weeks
Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC
Time frame: 6 weeks
Evaluation of TAC (TAV = TLC(BOX)-VA(IG))
Time frame: 6 weeks
Evaluation of slow vital capacity (SVC)
Time frame: 6 weeks
Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC
Time frame: 6 weeks
Evaluation of TGV, Raw, SGaw and RV
Time frame: 6 weeks
Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test
Time frame: 6 weeks
Physician's Global Assessment
Time frame: 6 weeks
Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise
Time frame: 6 weeks
Changes in Physical examination and ECG
Time frame: 6 weeks
Occurrence of Adverse Events
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim
28 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tiotropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 28 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Canada, Germany, Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time during a constant work rate exercise test to symptom limitation (time frame: 2 hours and 15 minutes after trial medication administration on Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.