Moderate Chronic Obstructive Pulmonary DiseaseCODExNCT01655199
Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease
A study of Moderate Chronic Obstructive Pulmonary Disease and Severe Chronic Obstructive Pulmonary Disease, run by Laval University at 2 sites in Canada.
Trial summary
During the previous phases of the project (Phase I and II), two new field tests have been designed and validated for an integration in a primary care setting in Chronic Obstructive Pulmonary Disease (COPD). These new field tests are 3-min paced-walk test (3MPWT) and 3-min paced step test (3MPST). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Moderate Chronic Obstructive Pulmonary Disease, Severe Chronic Obstructive Pulmonary Disease, Dyspnea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2012to Jul 2014
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age higher than 50 years old
- smoking history ≥ 10 packs/year
- post-bronchodilator FEV1 between 30 and 80% of the predicted value and FEV1/FVC lesser than 70% as assessed in previous pulmonary function test (corresponding to GOLD stages II and III)
Who cannot join
- respiratory exacerbation within the preceding 6 weeks
- asthmatic condition
- significant O2 desaturation (SaO2 < 85%) at rest or during exercise
- presence of another pathology that could influence exercise tolerance or may prevent the realization of the step test
- subject having a pacemaker
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 1 recruiting
- Recruiting
Montreal Chest Institute - McGill University
Montreal, Quebec
Jean Bourbeau, M.D, jean.bourbeau@mcgill.ca
Hélène Perrault, Ph.D, helene.perrault@mcgill.ca
- Active, not recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec, Quebec
About this study
Official title: Measurement of Exertional Dyspnea in the Primary Care Setting in Patients With COPD, Phase III: Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With COPD
During the previous phases of the project (Phase I and II), two new field tests have been designed and validated for an integration in a primary care setting in Chronic Obstructive Pulmonary Disease (COPD). These new field tests are 3-min paced-walk test (3MPWT) and 3-min paced step test (3MPST). If the validity and sensitivity of the TM3 could be highlighted, particularly by the reduction of dyspnea level following bronchodilatation, Phase II highlight that the 3MPST does not allow to detect this decrease of dyspnea after bronchodilatation. The use of too high step rates could explain these results through a hypothesis relative to neuromechanical coupling of dyspnea. The main objective of this trial is to follow the investigations on the sensitivity of 3MPST to detect the effects of pharmacological intervention on the exertional dyspnea in COPD patient. The hypothesis of this work is that the use of lower step rates cadences could allow to detect an improvement of exertional dyspnea following treatment-induced bronchodilatation, contrary to higher step rates.
Read the detailed description
For this project, 40 patients with COPD will be recruited in 2 centres (in the Institute of Cardiology and Pneumology of Quebec and in the Chest Institute of Montreal). For each patient, three visits will be performed. During the first visit, baseline pulmonary function and maximal exercise capacity will be evaluated and the patients will be familiarized with step test proceedings. Between the different visits, a 3-7 days period will be respected. During the second and the third visits, 4 step tests will be performed at 4 different rates, following one of the two conditions (placebo or bronchodilatation). This project will propose two randomization levels. The first randomization will be relative to the choice of the condition used during the second visit (placebo ou bronchodilatation) and the second one for the rates order (14, 16, 20, 24 steps/min). During each performed exercise, cardiorespiratory and pulmonary parameters will be measured using a portable system.
- Conditions
- Moderate Chronic Obstructive Pulmonary Disease, Severe Chronic Obstructive Pulmonary Disease, Dyspnea
- Being tested
- Combination ipratropium/salbutamol or placebo (nebulization)
- Keywords
- Chronic Obstructive Pulmonary Disease, Lung function, Exertional dyspnea, Exercise capacity, Pulmonary function, Pleural pressures
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination ipratropium/salbutamol or placebo (nebulization)Drug
Also called Combivent or placebo (nebulization)
For the visit 2, COPD patients will be randomly assigned a combination of ipratropium/salbutamol or a placebo in a double-blind crossover design. For the visit 3, the other intervention drug will be assigned. The bronchodilation obtained with the medication will allow to determine if the 3-min step test is sensitive by detecting an improvement of exertional dyspnea following bronchodilation.
| Study group | Role | What they receive |
|---|---|---|
| COPD group | Experimental | Moderate and/or severe COPD patients, corresponding to GOLD stages II and III. Receives: Drug: Combination ipratropium/salbutamol or placebo (nebulization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom perception
Patients will be asked to score their dyspnea and leg discomfort perception using a 10-point Borg scale.
Measured: change from baseline in Borg Scale at 3 min of exercise
Secondary outcomes (6)
Cardiac and ventilatory outcomes
Metabolic, cardiac and ventilatory parameters will be measured using a metabolic cart. Principal outcomes will be oxygen uptake (VO2), carbon dioxide output (VCO2), ventilation (VE), breathing frequency (BF), tidal volume (Vt) and heart rate (HR).
Measured: Change from baseline at 3 minutes of exercise
Inspiratory capacity
Inspiratory capacity will be measured at rest and at the end of the 3-min step test (immediately following the assessment of dyspnea at 3 minutes).
Measured: Change from baseline at the end of the exercise.
Respiratory pressures and diaphragm EMG
Tidal excursion in pleural pressure will be measured using an oesophageal balloon-catheter system that will be positioned using standardized technique (n=40). Gastric and transdiaphragmatic pressures as well as the diaphragm electromyogram will be recorded in the 20 subjects studied at McGill University using a multipair esophageal electrode-balloon catheter.
Measured: Change from baseline at 1, 2 and 3 minutes of exercise
Pulmonary function
Pulmonary function will be measured by spirometry and plethysmography in the initial visit. In the subsequent visits, pulmonary function will be evaluated by spirometry before and 60-min after the nebulization of either placebo or bronchodilator.
Measured: At baseline and 60-min after the nebulization of either placebo and bronchodilator
Maximal oxygen consumption
Exercise capacity will be directly assessed following an incremental cycle exercise test. The exercise capacity was defined as the maximal oxygen consumption (VO2 peak, ml/kg/min) by direct measurements of gas exchanges.
Measured: Change from baseline at 1, 2 and 3 minutes of exercise
Maximal inspiratory pressure (PImax)
The maximum inspiratory pressure (PImax) will be measured during a sniff manoeuvre. These measurements will allow to construct the ratio of respiratory effort (tidal Pes/PImax) to thoracic displacement (VT/predicted VC), an index of neuromechanical coupling
Measured: Change from baseline after 3 minutes of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Principal investigator, Benoit Borel, Laval University
- Investigators
- François Maltais, M.D, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655199
- Sponsor's protocol ID
- CODEX-20819
- Acronym
- CODEx
- Status last verified
- Sep 2013
- First submitted
- 25 Jul 2012
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Exertional Dyspnea in the Primary Care Setting in Patients With COPD, Phase III: Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With COPD
- ClinicalTrials.gov ID
- NCT01655199
- Acronym / sponsor ID
- CODEx / CODEX-20819
- Conditions
- Moderate Chronic Obstructive Pulmonary Disease, Severe Chronic Obstructive Pulmonary Disease, Dyspnea
- Keywords
- Chronic Obstructive Pulmonary Disease, Lung function, Exertional dyspnea, Exercise capacity, Pulmonary function, Pleural pressures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 1 Aug 2012 (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.
During the previous phases of the project (Phase I and II), two new field tests have been designed and validated for an integration in a primary care setting in Chronic Obstructive Pulmonary Disease (COPD). These new field tests are 3-min paced-walk test (3MPWT) and 3-min paced step test (3MPST). If the validity and sensitivity of the TM3 could be highlighted, particularly by the reduction of dyspnea level following bronchodilatation, Phase II highlight that the 3MPST does not allow to detect this decrease of dyspnea after bronchodilatation. The use of too high step rates could explain these results through a hypothesis relative to neuromechanical coupling of dyspnea. The main objective of this trial is to follow the investigations on the sensitivity of 3MPST to detect the effects of pharmacological intervention on the exertional dyspnea in COPD patient. The hypothesis of this work is that the use of lower step rates cadences could allow to detect an improvement of exertional dyspnea following treatment-induced bronchodilatation, contrary to higher step rates.
Detailed description
For this project, 40 patients with COPD will be recruited in 2 centres (in the Institute of Cardiology and Pneumology of Quebec and in the Chest Institute of Montreal). For each patient, three visits will be performed. During the first visit, baseline pulmonary function and maximal exercise capacity will be evaluated and the patients will be familiarized with step test proceedings. Between the different visits, a 3-7 days period will be respected. During the second and the third visits, 4 step tests will be performed at 4 different rates, following one of the two conditions (placebo or bronchodilatation). This project will propose two randomization levels. The first randomization will be relative to the choice of the condition used during the second visit (placebo ou bronchodilatation) and the second one for the rates order (14, 16, 20, 24 steps/min). During each performed exercise, cardiorespiratory and pulmonary parameters will be measured using a portable system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD group | Experimental | Drug: Combination ipratropium/salbutamol or placebo (nebulization)Moderate and/or severe COPD patients, corresponding to GOLD stages II and III. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age higher than 50 years old
- smoking history ≥ 10 packs/year
- post-bronchodilator FEV1 between 30 and 80% of the predicted value and FEV1/FVC lesser than 70% as assessed in previous pulmonary function test (corresponding to GOLD stages II and III)
Key exclusion criteria (5 listed)
- respiratory exacerbation within the preceding 6 weeks
- asthmatic condition
- significant O2 desaturation (SaO2 < 85%) at rest or during exercise
- presence of another pathology that could influence exercise tolerance or may prevent the realization of the step test
- subject having a pacemaker
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 |
|---|---|---|
| Combination ipratropium/salbutamol or placebo (nebulization)Also: Combivent or placebo (nebulization)For the visit 2, COPD patients will be randomly assigned a combination of ipratropium/salbutamol or a placebo in a double-blind crossover design. For the visit 3, the other intervention drug will be assigned. The bronchodilation obtained with the medication will allow to determine if the 3-min step test is sensitive by detecting an improvement of exertional dyspnea following bronchodilation. | Drug | COPD group |
Primary outcome
Symptom perception
Time frame: change from baseline in Borg Scale at 3 min of exercise
Patients will be asked to score their dyspnea and leg discomfort perception using a 10-point Borg scale.
6 secondary outcomes
Cardiac and ventilatory outcomes
Time frame: Change from baseline at 3 minutes of exercise
Inspiratory capacity
Time frame: Change from baseline at the end of the exercise.
Respiratory pressures and diaphragm EMG
Time frame: Change from baseline at 1, 2 and 3 minutes of exercise
Pulmonary function
Time frame: At baseline and 60-min after the nebulization of either placebo and bronchodilator
Maximal oxygen consumption
Time frame: Change from baseline at 1, 2 and 3 minutes of exercise
Maximal inspiratory pressure (PImax)
Time frame: Change from baseline after 3 minutes of exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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.
François Maltais, M.D principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Moderate Chronic Obstructive Pulmonary Disease and Severe Chronic Obstructive Pulmonary Disease, run by Laval University at 2 sites in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Maltais, M.D (418-656-4747, Francois.Maltais@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom perception (time frame: change from baseline in Borg Scale at 3 min of exercise). 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 18 Sep 2013.