Chronic Obstructive Pulmonary DiseaseNCT02235025
Asymptomatic Versus Symptomatic Mild COPD: Comparisons at Rest and at Exercise
A study testing Cardio-pulmonary exercise testing in people with Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The current definition of chronic obstructive pulmonary disease (COPD) is based on the presence of persistent airflow obstruction assessed by spirometry. About half of the subjects with mild COPD (i.e. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Cardio-pulmonary exercise testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to May 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For COPD groups: post-bronchodilator forced expiratory volume in 1 sec (FEV1) ≥ 80% predicted and a FEV1/forced vital capacity (FVC) ratio < 0.70
- For the "Asymptomatic mild COPD" group: modified Medical Research Council (mMRC) score equal to zero and absence of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze.
- For the "Symptomatic mild COPD" group: mMRC) score > 0
- For the "Healthy controls" group: FEV1 > 80% predicted and FEV1/FVC > 0.7) and a mMRC score equal to zero and absence of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze
- Able to perform all study procedures and provide informed consent
Who cannot join
- Presence of a medical condition other than COPD that could cause or contribute to breathlessness (i.e., a respiratory disease other than COPD and/or a metabolic and/or a cardiovascular disease)
- Presence of disorders other than COPD that could interfere with exercise testing, such as neuromuscular diseases or musculoskeletal problems
- History or clinical evidence of asthma
- Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventilatory Constraints During Exercise in Asymptomatic Versus Symptomatic Patients With Mild COPD
The current definition of chronic obstructive pulmonary disease (COPD) is based on the presence of persistent airflow obstruction assessed by spirometry. About half of the subjects with mild COPD (i.e. reduced forced expiratory volume in one second (FEV1) on forced vital capacity (FVC) ratio along with normal FEV1] are asymptomatic. Subjects with symptomatic mild COPD have reduced exercise tolerance and abnormal dynamic ventilatory mechanics compared to healthy subjects. The physiological and perceptual responses to exercise of subjects with asymptomatic mild COPD are currently unknown.
The purpose of this study is to assess exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea in asymptomatic mild COPD subjects undergoing incremental cycle cardiopulmonary exercise testing (CPET) to the limit of tolerance compared with symptomatic mild COPD and healthy controls.
Read the detailed description
Subjects attend one single visit. If needed, COPD subjects are asked to stop any respiratory related medication such as short and long acting bronchodilators 72 hours prior to the visit. Subjects are asked to arrive early in the morning. After informed consent and appropriate screening of medical history, all subjects complete the mMRC scale. A complete medical history is collected. Subjects thereafter complete pulmonary function testing pre- and 30-min post-bronchodilator. Subjects are given a normal mixed meal and are asked not to drink alcohol or coffee.
A symptom-limited incremental cycle exercise test is performed on the same day, at least 6 hours after the bronchodilator test and at least 4 hours after the meal. After a steady-state resting period, a 3-min warm-up is conducted at about 20% of individually estimated maximal work load (Wmax), and the load is increased every minute in such a way that the test duration is >8 and <12 min. The following data are obtained breath by breath and expressed as 30-s averages: V'O2 and carbon dioxide production (V'CO2); minute ventilation (V'E); tidal volume (VT); respiratory rate; and ventilatory equivalents for oxygen and carbon dioxide. Blood pressure is measured every minute by a sphygmomanometer. Blood samples are withdrawn from the arterialized earlobe at rest and at near-maximal exercise. Tests are terminated at the point of symptom limitation (peak exercise). Upon exercise cessation, subjects are asked to verbalize their main reason for stopping exercise (breathing discomfort, leg discomfort or both).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Cardio-pulmonary exercise testing
- Keywords
- mild COPD, dyspnea, exercise, respiratory mechanics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio-pulmonary exercise testingOther
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic mild COPD | Other | Subjects of this group have GOLD grade I COPD (post-bronchodilator FEV1 > 80% predicted and FEV1/FVC < 0.7). They also have a modified Medical Research Council (mMRC) score equal to zero and are free of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze. Receives: Other: Cardio-pulmonary exercise testing |
| Symptomatic mild COPD | Other | Subjects of this group have GOLD grade I COPD (post-bronchodilator FEV1 > 80% predicted and FEV1/FVC < 0.7). They also have a modified Medical Research Council (mMRC) score > 0. Receives: Other: Cardio-pulmonary exercise testing |
| Healthy controls | Other | Healthy controls have normal baseline spirometry (FEV1 > 80% predicted, FEV1/FVC > 0.7). They don't have any health problems, including cardiovascular, metabolic, neuromuscular, musculoskeletal, or respiratory diseases that could contribute to breathlessness or exercise limitation. They have a mMRC score equal to zero and do not complain any respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze and/or chronic respiratory related medication. Receives: Other: Cardio-pulmonary exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea intensity measured by the 10-point Borg scale during cycle exercise
Dyspnea intensity is measured at rest and every two minutes thereafter. Dyspnea intensity at 80% of maximal predicted work rate is calculated by linear interpolation between adjacent measurement points for each subject
Measured: up to 12 minutes
Secondary outcomes (2)
Inspiratory capacity
Inspiratory capacity as a function of work rate is studied as a continuous variable. In addition, a decrease in inspiratory capacity from rest of more than 150 mL at any time-point during exercise defines dynamic hyperinflation
Measured: up to 12 minutes
Tidal volume as a function of minute ventilation
In the relationship between tidal volume (VT) and minute ventilation (V'E), there is an inflection point beyond which almost no further change in VT is possible despite a continued increase in V'E. This inflection in the VT response marks the point were dyspnoea sharply raises because of mechanical constraints on VT expansion. This inflection point is determined for each patient by analyzing individual Hey plot
Measured: up to 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Degano, MD, PhD, Principal investigator, CHU Besançon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235025
- Sponsor's protocol ID
- BAL-1
- Status last verified
- Aug 2014
- First submitted
- 27 Aug 2014
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Constraints During Exercise in Asymptomatic Versus Symptomatic Patients With Mild COPD
- ClinicalTrials.gov ID
- NCT02235025
- Acronym / sponsor ID
- BAL-1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- mild COPD, dyspnea, exercise, respiratory mechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Sep 2014 (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 current definition of chronic obstructive pulmonary disease (COPD) is based on the presence of persistent airflow obstruction assessed by spirometry. About half of the subjects with mild COPD (i.e. reduced forced expiratory volume in one second (FEV1) on forced vital capacity (FVC) ratio along with normal FEV1] are asymptomatic. Subjects with symptomatic mild COPD have reduced exercise tolerance and abnormal dynamic ventilatory mechanics compared to healthy subjects. The physiological and perceptual responses to exercise of subjects with asymptomatic mild COPD are currently unknown.
The purpose of this study is to assess exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea in asymptomatic mild COPD subjects undergoing incremental cycle cardiopulmonary exercise testing (CPET) to the limit of tolerance compared with symptomatic mild COPD and healthy controls.
Detailed description
Subjects attend one single visit. If needed, COPD subjects are asked to stop any respiratory related medication such as short and long acting bronchodilators 72 hours prior to the visit. Subjects are asked to arrive early in the morning. After informed consent and appropriate screening of medical history, all subjects complete the mMRC scale. A complete medical history is collected. Subjects thereafter complete pulmonary function testing pre- and 30-min post-bronchodilator. Subjects are given a normal mixed meal and are asked not to drink alcohol or coffee.
A symptom-limited incremental cycle exercise test is performed on the same day, at least 6 hours after the bronchodilator test and at least 4 hours after the meal. After a steady-state resting period, a 3-min warm-up is conducted at about 20% of individually estimated maximal work load (Wmax), and the load is increased every minute in such a way that the test duration is >8 and <12 min. The following data are obtained breath by breath and expressed as 30-s averages: V'O2 and carbon dioxide production (V'CO2); minute ventilation (V'E); tidal volume (VT); respiratory rate; and ventilatory equivalents for oxygen and carbon dioxide. Blood pressure is measured every minute by a sphygmomanometer. Blood samples are withdrawn from the arterialized earlobe at rest and at near-maximal exercise. Tests are terminated at the point of symptom limitation (peak exercise). Upon exercise cessation, subjects are asked to verbalize their main reason for stopping exercise (breathing discomfort, leg discomfort or both).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic mild COPD | Other | Other: Cardio-pulmonary exercise testingSubjects of this group have GOLD grade I COPD (post-bronchodilator FEV1 > 80% predicted and FEV1/FVC < 0.7). They also have a modified Medical Research Council (mMRC) score equal to zero and are free of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze. |
| Symptomatic mild COPD | Other | Other: Cardio-pulmonary exercise testingSubjects of this group have GOLD grade I COPD (post-bronchodilator FEV1 > 80% predicted and FEV1/FVC < 0.7). They also have a modified Medical Research Council (mMRC) score > 0. |
| Healthy controls | Other | Other: Cardio-pulmonary exercise testingHealthy controls have normal baseline spirometry (FEV1 > 80% predicted, FEV1/FVC > 0.7). They don't have any health problems, including cardiovascular, metabolic, neuromuscular, musculoskeletal, or respiratory diseases that could contribute to breathlessness or exercise limitation. They have a mMRC score equal to zero and do not complain any respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze and/or chronic respiratory related medication. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For COPD groups: post-bronchodilator forced expiratory volume in 1 sec (FEV1) ≥ 80% predicted and a FEV1/forced vital capacity (FVC) ratio < 0.70
- For the "Asymptomatic mild COPD" group: modified Medical Research Council (mMRC) score equal to zero and absence of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze.
- For the "Symptomatic mild COPD" group: mMRC) score > 0
- For the "Healthy controls" group: FEV1 > 80% predicted and FEV1/FVC > 0.7) and a mMRC score equal to zero and absence of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze
- Able to perform all study procedures and provide informed consent
Key exclusion criteria (4 listed)
- Presence of a medical condition other than COPD that could cause or contribute to breathlessness (i.e., a respiratory disease other than COPD and/or a metabolic and/or a cardiovascular disease)
- Presence of disorders other than COPD that could interfere with exercise testing, such as neuromuscular diseases or musculoskeletal problems
- History or clinical evidence of asthma
- Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air
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 |
|---|---|---|
| Cardio-pulmonary exercise testing | Other | Asymptomatic mild COPD, Healthy controls, Symptomatic mild COPD |
Primary outcome
Dyspnea intensity measured by the 10-point Borg scale during cycle exercise
Time frame: up to 12 minutes
Dyspnea intensity is measured at rest and every two minutes thereafter. Dyspnea intensity at 80% of maximal predicted work rate is calculated by linear interpolation between adjacent measurement points for each subject
2 secondary outcomes
Inspiratory capacity
Time frame: up to 12 minutes
Tidal volume as a function of minute ventilation
Time frame: up to 12 minutes
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 9 Sep 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.
Bruno Degano, MD, PhD principal investigator
CHU Besançon, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio-pulmonary exercise testing in people with Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 5 inclusion and 4 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 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
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?
Dyspnea intensity measured by the 10-point Borg scale during cycle exercise (time frame: up to 12 minutes). 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 9 Sep 2014.