Pulmonary Disease, Chronic ObstructivePhase 3NCT00274521
Tiotropium (Spiriva) Rehabilitation Study
A Phase 3 study testing Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 19 sites in United States.
Trial summary
The study was designed to determine whether tiotropium inhalation capsules, compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium
- How many people
- 108 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2001to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of COPD, FEV1 of less than or equal than 60% of predicted normal and less than or equal to 70% at Visit 1, Male or Female 40 years or greater, smoking history of more than 10 pack years (current or ex-smokers), patient can perform all study related tests, patients can inhale medication from HandiHaler and from meter dose inhaler, patients who would benefit from participation in a pulmonary rehab program and patients who had a medical clearance to participate in a pulmonary rehab program.
Who cannot join
- Patients with significant diseases other than COPD, patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis, all patients with SGOT greater than 80IU/L, bilirubin greater than 2.0 mg/dl or creatinine greater than 2.0 mg/dL, recent history of MI (6 months or less). any cardiac arrhythmia requiring drug therapy or has abeen hospitalized for heart failure with the past 3 years, active TB, history of CA or had treatment within the last 24 months, history of CF, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of Alabama at Birmingham
Birmingham, Alabama
Boehringer Ingelheim Investigational Site
Danbury, Connecticut
Attention: John E. Hodgkin, M.D.
Deer Park, California
Henry Ford Hospital
Detroit, Michigan
Duke University Medical Center
Durhan, North Carolina
Boehringer Ingelheim Investigational Site
Elk Grove Village, Illinois
Boehringer Ingelheim Investigational Site
Everett, Washington
Boehringer Ingelheim Investigational Site
Fort Collins, Colorado
St. Francis Hospital and Medical Center
Hartford, Connecticut
Boehringer Ingelheim Investigational Site
Long Beach, California
UCLA School of Medicine
Los Angeles, California
UMass Memorial Medical Center
North Worcester, Massachusetts
Norwalk Hospital
Norwalk, Connecticut
University of Nebraska Medical Center
Omaha, Nebraska
Temple University Hospital
Philadelphia, Pennsylvania
Boehringer Ingelheim Investigational Site
Phoenix, Arizona
Boehringer Ingelheim Investigational Site
San Diego, California
Harbor-UCLA Research and Education Institute
Torrance, California
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
About this study
Official title: A Randomized, Double-blind, Placebo Controlled 25-week Trial to Compare the Effect of Tiotropium Inhalation Capsuled (18 Mcg) Once Daily on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 8 Weeks of Pulmonary Rehabilitation.
The study was designed to determine whether tiotropium inhalation capsules, compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. In addition, assessments of the effect of tiotropium on dyspnea and quality of life following pulmonary rehabilitation were taken.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium
- 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.
TiotropiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change in submaximal exercise tolerance (prior to treatment to after pulmonary rehabilitation) as measured by endurance time during a constant work rate treadmill exercise test at 80% of maximum work capacity
Measured: week 13
Secondary outcomes (16)
Individual FEV1 measurement
Measured: week 4, 13, 25
Individual FVC measurement
Measured: week 4, 13, 25
St. George.s Hospital Respiratory Questionnaire (SGRQ)
Measured: week 4, 13, 25
Transition dyspnea index
Measured: week 4, 13, 25
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Measured: week 4, 13, 25
Modified Borg scale
Measured: week 4, 13, 25
Amount of albuterol therapy used during the treatment period
Measured: 25 weeks
Number and length of exacerbations of COPD
Measured: 25 weeks
Physician's global evaluation
Measured: week 4, 13, 25
Patient peak flow rates twice daily
Measured: 25 weeks
Patient activity measurement
Measured: week 9, 13, 17, 21, 25
Change in submaximal exercise tolerance during constant work rate exercise
Measured: week 25
Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation.
Measured: week 13
Occurrence of adverse events
Measured: 25 weeks
Pulse rate and blood pressure in conjunction with spirometry
Measured: 25 weeks
Changes in the physical examination from baseline and at the conclusion of patient participation in the trial
Measured: 25 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 startMay 2001
- Primary completionFeb 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
- 108 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274521
- Sponsor's protocol ID
- 205.230
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2006
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled 25-week Trial to Compare the Effect of Tiotropium Inhalation Capsuled (18 Mcg) Once Daily on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 8 Weeks of Pulmonary Rehabilitation.
- ClinicalTrials.gov ID
- NCT00274521
- Acronym / sponsor ID
- 205.230
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Feb 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.
The study was designed to determine whether tiotropium inhalation capsules, compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. In addition, assessments of the effect of tiotropium on dyspnea and quality of life following pulmonary rehabilitation were taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of COPD, FEV1 of less than or equal than 60% of predicted normal and less than or equal to 70% at Visit 1, Male or Female 40 years or greater, smoking history of more than 10 pack years (current or ex-smokers), patient can perform all study related tests, patients can inhale medication from HandiHaler and from meter dose inhaler, patients who would benefit from participation in a pulmonary rehab program and patients who had a medical clearance to participate in a pulmonary rehab program.
Key exclusion criteria (1 listed)
- Patients with significant diseases other than COPD, patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis, all patients with SGOT greater than 80IU/L, bilirubin greater than 2.0 mg/dl or creatinine greater than 2.0 mg/dL, recent history of MI (6 months or less). any cardiac arrhythmia requiring drug therapy or has abeen hospitalized for heart failure with the past 3 years, active TB, history of CA or had treatment within the last 24 months, history of CF, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
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 | Drug | – |
Primary outcome
The primary endpoint is the change in submaximal exercise tolerance (prior to treatment to after pulmonary rehabilitation) as measured by endurance time during a constant work rate treadmill exercise test at 80% of maximum work capacity
Time frame: week 13
16 secondary outcomes
Individual FEV1 measurement
Time frame: week 4, 13, 25
Individual FVC measurement
Time frame: week 4, 13, 25
St. George.s Hospital Respiratory Questionnaire (SGRQ)
Time frame: week 4, 13, 25
Transition dyspnea index
Time frame: week 4, 13, 25
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time frame: week 4, 13, 25
Modified Borg scale
Time frame: week 4, 13, 25
Amount of albuterol therapy used during the treatment period
Time frame: 25 weeks
Number and length of exacerbations of COPD
Time frame: 25 weeks
Physician's global evaluation
Time frame: week 4, 13, 25
Patient peak flow rates twice daily
Time frame: 25 weeks
Patient activity measurement
Time frame: week 9, 13, 17, 21, 25
Change in submaximal exercise tolerance during constant work rate exercise
Time frame: week 25
Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation.
Time frame: week 13
Occurrence of adverse events
Time frame: 25 weeks
Pulse rate and blood pressure in conjunction with spirometry
Time frame: 25 weeks
Changes in the physical examination from baseline and at the conclusion of patient participation in the trial
Time frame: 25 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 Nov 2013.
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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
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 19 sites in United States.
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 1 inclusion and 1 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 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in 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?
The primary endpoint is the change in submaximal exercise tolerance (prior to treatment to after pulmonary rehabilitation) as measured by endurance time during a constant work rate treadmill exercise test at 80% of maximum work capacity (time frame: week 13). 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 Nov 2013; AzTrials last refreshed its copy on 30 Oct 2026.