Pulmonary Disease, Chronic ObstructivePhase 3NCT00157235
Effect of Tiotropium Inhalation Capsules (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 12 sites in Italy.
Trial summary
The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio), 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 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium bromide
- How many people
- 234 participants
- Where
- 12 sitesItaly
- Study dates
- Sep 2002to Apr 2006
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients with FEV1 less 60% of predicted FEV1 less 70% of FVC.
Who cannot join
- Patients with any respiratory infection in the six weeks prior to the Screening Visit or during the run-in period (between Visits 1 and 2).
- Patients with a recent history (i.e., 6 months - or less) of myocardial infarction.
- Patients with any cardiac arrhythmia requiring drug therapy in the past year or who have been hospitalized for heart failure within the past three years.
- Patients with symptomatic benign prostatic hypertrophy or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
Fondazione "S. Maugeri"
Bari, 70020
Azienda Sanitaria Locale
Casorate Primo (PV), 27022
Arcispedale S. Anna
Ferrara, 44100
U.O. dimedicina Preventiva del Lavoro
Genova, 16132
Fondazione Maugeri
Gussago (BS), 25064
Universita degli Studi di Pisa
Pisa, 56124
Fondazione Don Gnocchi
Pozzolatico (FI), 50020
Azienda Ospedaliera S. Camillo Forlanini
Roma, 00149
Fondazione S. Maugeri
Telese Terme (BN), 82037
Fondazione "S. Maugeri"
Tradate (VA), 21049
Ospedali Riuniti di Trieste
Trieste, 34100
Casa di Cura San Raffaele
Velletri (Roma), 00049
About this study
Official title: A Randomized, Double Blind , Placebo Controlled Trial to Compare the Effect of Tiotropium Inhalation Capsules on Exercise Tolerance in Patients With COPD Participating in 8 Weeks of Pulmonary Rehabilitation
The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation.
Read the detailed description
This is an 25-week multicenter, single country, randomised, double-blind, placebo-controlled, parallel group study to compare the efficacy of tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio) in patients with COPD participating in a pulmonary rehabilitation program.
Following an initial screening, patients will perform a six minute walk test (Visit 1) and enter a 4-week run-in period. Patients will subsequently be randomized to tiotropium or placebo inhalation capsules taken once daily in the morning for the next 25 weeks. After successfully completing 4 weeks of study drug self-administration, patients will enter a period of pulmonary rehabilitation.
Pulmonary rehabilitation will include aerobic lower limb exercise 3 times weekly for 8 weeks. After the last pulmonary rehabilitation session, patients will continue on study medication for a 12 week follow-up period.
Six minute walk tests will be repeated during the run-in period at Week 0 (Visit 2) and Week 4 (Visit 3), at the conclusion of the 8 weeks of pulmonary rehabilitation (Visit 6) and the 12 weeks of follow-up (Visit 9).
Pulmonary function testing will be conducted prior to the start of therapy at Visit 1 and at Visits 2 (week 0 ), 3 (week 4 ), 6 (week 13 ) and 9 (week 25 ).
Study Hypothesis:
The null hypothesis is that there is no difference in the increase in six minute walk distance between tiotropium and placebo groups following 8 weeks pulmonary rehabilitation program. The alternative hypothesis is that tiotropium with pulmonary rehabilitation increases six minute walk distance more than placebo with pulmonary rehabilitation. However, the two-sided test of hypothesis will be performed at 0.05 level of significance.
Comparison(s):
The primary endpoint is the six minute walk distance at visit 6. This endpoint will be compared between tiotropium and placebo using an analysis of covariance model with treatment, center and baseline (six-minute walk distance measured at visit 2 prior to dosing) as a covariate. Fifty-four meters has been determined to be the difference in six minute walk distance between tiotropium (Spiriva, Bromuro de Tiotropio) and placebo at 5% level of significance with at least 80% power using a two-tailed t-test.. .
- 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.
Change in six minute walk distance after 8 weeks of pulmonary rehabilitation.
Measured: week 13
Secondary outcomes (14)
Individual FEV1 measurement
Measured: week 4, 13, 25
Individual FVC measurement
Measured: week 4, 13, 25
St. George's Hospital Respiratory Questionnaire (SGRQ)
Measured: Time Frame: 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
Amount of salbutamol 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 (PEFR) twice daily
Measured: 25 weeks
Patient activity measurement
Measured: week 4, 9, 13, 17, 21, 25
Six minute walk distance
Measured: week 13, 25
Occurrence of adverse events
Measured: 25 weeks
Changes from baseline in 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 posted12 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionApr 2006
- Study completionApr 2006
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
- 234 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, BI Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157235
- Sponsor's protocol ID
- 205.247
- Status last verified
- Dec 2017
- First submitted
- 7 Sep 2005
- Last updated
- 28 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind , Placebo Controlled Trial to Compare the Effect of Tiotropium Inhalation Capsules on Exercise Tolerance in Patients With COPD Participating in 8 Weeks of Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT00157235
- Acronym / sponsor ID
- 205.247
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 12 Sep 2005 (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 objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation.
Detailed description
This is an 25-week multicenter, single country, randomised, double-blind, placebo-controlled, parallel group study to compare the efficacy of tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio) in patients with COPD participating in a pulmonary rehabilitation program.
Following an initial screening, patients will perform a six minute walk test (Visit 1) and enter a 4-week run-in period. Patients will subsequently be randomized to tiotropium or placebo inhalation capsules taken once daily in the morning for the next 25 weeks. After successfully completing 4 weeks of study drug self-administration, patients will enter a period of pulmonary rehabilitation.
Pulmonary rehabilitation will include aerobic lower limb exercise 3 times weekly for 8 weeks. After the last pulmonary rehabilitation session, patients will continue on study medication for a 12 week follow-up period.
Six minute walk tests will be repeated during the run-in period at Week 0 (Visit 2) and Week 4 (Visit 3), at the conclusion of the 8 weeks of pulmonary rehabilitation (Visit 6) and the 12 weeks of follow-up (Visit 9).
Pulmonary function testing will be conducted prior to the start of therapy at Visit 1 and at Visits 2 (week 0 ), 3 (week 4 ), 6 (week 13 ) and 9 (week 25 ).
Study Hypothesis:
The null hypothesis is that there is no difference in the increase in six minute walk distance between tiotropium and placebo groups following 8 weeks pulmonary rehabilitation program. The alternative hypothesis is that tiotropium with pulmonary rehabilitation increases six minute walk distance more than placebo with pulmonary rehabilitation. However, the two-sided test of hypothesis will be performed at 0.05 level of significance.
Comparison(s):
The primary endpoint is the six minute walk distance at visit 6. This endpoint will be compared between tiotropium and placebo using an analysis of covariance model with treatment, center and baseline (six-minute walk distance measured at visit 2 prior to dosing) as a covariate. Fifty-four meters has been determined to be the difference in six minute walk distance between tiotropium (Spiriva, Bromuro de Tiotropio) and placebo at 5% level of significance with at least 80% power using a two-tailed t-test.. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients with FEV1 less 60% of predicted FEV1 less 70% of FVC.
Key exclusion criteria (5 listed)
- Patients with any respiratory infection in the six weeks prior to the Screening Visit or during the run-in period (between Visits 1 and 2).
- Patients with a recent history (i.e., 6 months - or less) of myocardial infarction.
- Patients with any cardiac arrhythmia requiring drug therapy in the past year or who have been hospitalized for heart failure within the past three years.
- Patients with symptomatic benign prostatic hypertrophy or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
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
Change in six minute walk distance after 8 weeks of pulmonary rehabilitation.
Time frame: week 13
14 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: 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
Amount of salbutamol 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 (PEFR) twice daily
Time frame: 25 weeks
Patient activity measurement
Time frame: week 4, 9, 13, 17, 21, 25
Six minute walk distance
Time frame: week 13, 25
Occurrence of adverse events
Time frame: 25 weeks
Changes from baseline in 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 28 Dec 2017.
- Related InfoLink provided by the sponsor.
- 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
BI Italy
12 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 bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 12 sites in Italy.
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 5 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 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. 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?
Change in six minute walk distance after 8 weeks of pulmonary rehabilitation. (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 28 Dec 2017.