Pulmonary Disease, Chronic ObstructivePhase 4NCT01072396
Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 15 sites in 2 countries.
Trial summary
Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Feb 2010to Nov 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio <70%., FEV1 >/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.
Who cannot join
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.
- Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.
- Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States11 sites
205.440.1006 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
205.440.1019 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
205.440.1018 Boehringer Ingelheim Investigational Site
Hartford, Connecticut
205.440.1015 Boehringer Ingelheim Investigational Site
Jasper, Alabama
205.440.1011 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire
205.440.1020 Boehringer Ingelheim Investigational Site
Livonia, Michigan
205.440.1017 Boehringer Ingelheim Investigational Site
Muncie, Indiana
205.440.1013 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
205.440.1007 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
205.440.1008 Boehringer Ingelheim Investigational Site
Springfield, Illinois
205.440.1002 Boehringer Ingelheim Investigational Site
Torrance, California
Canada4 sites
205.440.2003 Boehringer Ingelheim Investigational Site
Kingston, Ontario
205.440.2001 Boehringer Ingelheim Investigational Site
Montreal, Quebec
205.440.2004 Boehringer Ingelheim Investigational Site
Montreal, Quebec
205.440.2002 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)
Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium, Placebo
- 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
double blind randomized crossover
PlaceboDrug
inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
| Study group | Role | What they receive |
|---|---|---|
| 18 mcg tiotropium | Active comparator | Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler Receives: Drug: Tiotropium |
| Placebo | Placebo comparator | Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler Receives: Drug: Placebo |
| Control | No intervention | Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Inspiratory Capacity (IC) at Isotime
Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.
Measured: baseline, six weeks of treatment
Secondary outcomes (2)
Constant Work Rate (CWR) Endurance Time
CWR exercise duration calculated as the length of time of the exercise period
Measured: six weeks of treatment
Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime
Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).
Measured: baseline, six weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072396
- Sponsor's protocol ID
- 205.440
- Status last verified
- Apr 2013
- First submitted
- 19 Feb 2010
- Last updated
- 24 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Porszasz J, Blonshine S, Cao R, Paden HA, Casaburi R, Rossiter HB. Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials. BMC Pulm Med. 2016 Jan 16;16:13. doi: 10.1186/s12890-016-0174-8.
PubMed 26775292Gagnon P, Casaburi R, Saey D, Porszasz J, Provencher S, Milot J, Bourbeau J, O'Donnell DE, Maltais F. Cluster Analysis in Patients with GOLD 1 Chronic Obstructive Pulmonary Disease. PLoS One. 2015 Apr 23;10(4):e0123626. doi: 10.1371/journal.pone.0123626. eCollection 2015.
PubMed 25906326Casaburi R, Maltais F, Porszasz J, Albers F, Deng Q, Iqbal A, Paden HA, O'Donnell DE; 205.440 Investigators. Effects of tiotropium on hyperinflation and treadmill exercise tolerance in mild to moderate chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Nov;11(9):1351-61. doi: 10.1513/AnnalsATS.201404-174OC.
PubMed 25289942O'Donnell DE, Maltais F, Porszasz J, Webb KA, Albers FC, Deng Q, Iqbal A, Paden HA, Casaburi R; 205.440 investigators. The continuum of physiological impairment during treadmill walking in patients with mild-to-moderate COPD: patient characterization phase of a randomized clinical trial. PLoS One. 2014 May 1;9(5):e96574. doi: 10.1371/journal.pone.0096574. eCollection 2014.
PubMed 24788342
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01072396
- Acronym / sponsor ID
- 205.440
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Feb 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Posted 15 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 18 mcg tiotropium | Active comparator | Drug: TiotropiumPatient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler |
| Placebo | Placebo comparator | Drug: PlaceboPatient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler |
| Control | No intervention | –Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio <70%., FEV1 >/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.
Key exclusion criteria (3 listed)
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.
- Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.
- Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.
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 |
|---|---|---|
| Tiotropiumdouble blind randomized crossover | Drug | 18 mcg tiotropium |
| Placeboinhalation powder capsule identical to those containing tiotropium bromide inhalation powder | Drug | Placebo |
Primary outcome
Change From Baseline in Inspiratory Capacity (IC) at Isotime
Time frame: baseline, six weeks of treatment
Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.
2 secondary outcomes
Constant Work Rate (CWR) Endurance Time
Time frame: six weeks of treatment
Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime
Time frame: baseline, six weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26775292Porszasz J, Blonshine S, Cao R, Paden HA, Casaburi R, Rossiter HB. Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials. BMC Pulm Med. 2016 Jan 16;16:13. doi: 10.1186/s12890-016-0174-8.
- Derived from this study: PubMed 25906326Gagnon P, Casaburi R, Saey D, Porszasz J, Provencher S, Milot J, Bourbeau J, O'Donnell DE, Maltais F. Cluster Analysis in Patients with GOLD 1 Chronic Obstructive Pulmonary Disease. PLoS One. 2015 Apr 23;10(4):e0123626. doi: 10.1371/journal.pone.0123626. eCollection 2015.
- Derived from this study: PubMed 25289942Casaburi R, Maltais F, Porszasz J, Albers F, Deng Q, Iqbal A, Paden HA, O'Donnell DE; 205.440 Investigators. Effects of tiotropium on hyperinflation and treadmill exercise tolerance in mild to moderate chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Nov;11(9):1351-61. doi: 10.1513/AnnalsATS.201404-174OC.
- Derived from this study: PubMed 24788342O'Donnell DE, Maltais F, Porszasz J, Webb KA, Albers FC, Deng Q, Iqbal A, Paden HA, Casaburi R; 205.440 investigators. The continuum of physiological impairment during treadmill walking in patients with mild-to-moderate COPD: patient characterization phase of a randomized clinical trial. PLoS One. 2014 May 1;9(5):e96574. doi: 10.1371/journal.pone.0096574. eCollection 2014.
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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 chair
Boehringer Ingelheim
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 15 sites in 2 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 1 inclusion and 3 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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Inspiratory Capacity (IC) at Isotime (time frame: baseline, six weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01072396, which also lists 4 linked publications.
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 24 Dec 2013.