CoughREFLEXE TOUXNCT02882555
Effect of Muscular Exercise on Cough Reflex
A study testing Exercise, Capsaicin and Normal saline in people with Cough, run by Central Hospital, Nancy, France.
Trial summary
The hypothesis is that the cough reflex induced by capsaicin is inhibited during exercise. The purpose of this study is to determine if a short muscular exercise inhibits the cough reflex induced by capsaicin inhalation. Read more about this study
- Who is it for?
- Ages 7 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- Exercise, Capsaicin and Normal saline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 2013
- 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 7 to 77 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Obtaining of informed consent (or informed consent of parents or persons with parental authority)
- Affiliation to social security
- Negative answer to all 12 questions of medical questionnaire for child or to all 11 questions of medical questionnaire for adult
- Normal cardio-respiratory examination
- Normal electrocardiogram
- Without spirometry obstructive syndrome (FEV1 > 70% of predicted value and FEV1/FVC >70%)
Who cannot join
- Refusal or impossibility of obtaining informed consent of person or of persons with parental authority)
About this study
The hypothesis is that the cough reflex induced by capsaicin is inhibited during exercise. The purpose of this study is to determine if a short muscular exercise inhibits the cough reflex induced by capsaicin inhalation.
Read the detailed description
Cough is an important reflex of defense of airways. It is also one of the more frequent symptoms during respiratory diseases. Chronic cough can be a disabling condition, apparently idiopathic or associated to pathology such as asthma, sinusitis with posterior discharge or gastroesophageal reflux.
Factors susceptible to provoke or increase cough are well known, but inhibiting factors are much less known. Muscular exercise is thought to influence respiratory reflexes in a considerable and complicated way. For example, a bronchodilation is observed in healthy or asthmatic individuals, but recovery period frequently triggers asthma attacks. Effects of exercise on cough reflex are much less known.
This study aims to determine the influence of muscular exercise on cough reflex in children and healthy adults.
Highlighting the inhibition of cough reflex by exercise can have a significant effect on chronic cough patient care. There is actually no symptomatic treatment really effective without side effects.
- Conditions
- Cough
- Being tested
- Exercise, Capsaicin, Normal saline
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
6 min running on a motor-driven tredmill in a climate room (18-20°C, humidity <10 mg/l). Tredmill speed and slope are adjusted to increase heart rate to about 80 % of maximum value predicted for age (= 210 - age in years) during the first 2-3 min and pursued until the end of exercise (3-4 min). Heart rate is measured during the whole exercise.
CapsaicinDrug
A compressed air-driven nebuliser is controlled by a dosimeter and a valve is used to deliver similar inspiratory flows for 400 msec in children and 1200 msec in adults.
Normal salineDrug
A compressed air-driven nebuliser is controlled by a dosimeter and a valve is used to deliver similar inspiratory flows for 400 msec in children and 1200 msec in adults.
| Study group | Role | What they receive |
|---|---|---|
| Children | Experimental | 12 concentrations of caspaicin are administered: - 0.6, 1.2, 2.4, 4.8, 9.8, 19.5, 39, 78.1, 156.2, 312.5, 625, 1250 μmol/l. Capsaicin concentration eliciting at least 2 coughs (C2) or 5 coughs (C5) is determined.
At least 1-hour-interval from capsaicin dose titration (in order to minimize tachyphylaxy)
Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls (normal saline) in random order at baseline
At least 1-hour-interval (in order to minimize tachyphylaxy)
Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls in random order during exercise, when heart rate is maximum Receives: Behavioral: Exercise; Drug: Capsaicin; Drug: Normal saline |
| Adults | Active comparator | As reference for more precise assessment of effects of development.
12 concentrations of caspaicin are administered: 0.49, 0.98, 1.95, 3.9, 7.8, 15.6, 31.3, 62.5, 125, 250, 500, 1000 μmol/l. Capsaicin concentration eliciting at least 2 coughs (C2) or 5 coughs (C5) is determined.
At least 1-hour-interval from capsaicin dose titration (in order to minimize tachyphylaxy)
Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls (normal saline) in random order at baseline
At least 1-hour-interval (in order to minimize tachyphylaxy)
Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls in random order during exercise, when heart rate is maximum Receives: Behavioral: Exercise; Drug: Capsaicin; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cough efforts occurring within 15 sec of the C5 aerosol at baseline and during exercise
Video-taped and identified from its sound by 2 observers
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François MARCHAL, Pr, Principal investigator, Explorations fonctionnelles pédiatriques, Hôpital d'enfants, CHRU de Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882555
- Sponsor's protocol ID
- 2009-A00390-57
- Acronym
- REFLEXE TOUX
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscular Exercise on Cough Reflex
- ClinicalTrials.gov ID
- NCT02882555
- Acronym / sponsor ID
- REFLEXE TOUX / 2009-A00390-57
- Conditions
- Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Aug 2016 (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 hypothesis is that the cough reflex induced by capsaicin is inhibited during exercise. The purpose of this study is to determine if a short muscular exercise inhibits the cough reflex induced by capsaicin inhalation.
Detailed description
Cough is an important reflex of defense of airways. It is also one of the more frequent symptoms during respiratory diseases. Chronic cough can be a disabling condition, apparently idiopathic or associated to pathology such as asthma, sinusitis with posterior discharge or gastroesophageal reflux.
Factors susceptible to provoke or increase cough are well known, but inhibiting factors are much less known. Muscular exercise is thought to influence respiratory reflexes in a considerable and complicated way. For example, a bronchodilation is observed in healthy or asthmatic individuals, but recovery period frequently triggers asthma attacks. Effects of exercise on cough reflex are much less known.
This study aims to determine the influence of muscular exercise on cough reflex in children and healthy adults.
Highlighting the inhibition of cough reflex by exercise can have a significant effect on chronic cough patient care. There is actually no symptomatic treatment really effective without side effects.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | Experimental | Behavioral: Exercise, Drug: Capsaicin, Drug: Normal saline12 concentrations of caspaicin are administered: - 0.6, 1.2, 2.4, 4.8, 9.8, 19.5, 39, 78.1, 156.2, 312.5, 625, 1250 μmol/l. Capsaicin concentration eliciting at least 2 coughs (C2) or 5 coughs (C5) is determined. At least 1-hour-interval from capsaicin dose titration (in order to minimize tachyphylaxy) Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls (normal saline) in random order at baseline At least 1-hour-interval (in order to minimize tachyphylaxy) Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls in random order during exercise, when heart rate is maximum |
| Adults | Active comparator | Behavioral: Exercise, Drug: Capsaicin, Drug: Normal salineAs reference for more precise assessment of effects of development. 12 concentrations of caspaicin are administered: 0.49, 0.98, 1.95, 3.9, 7.8, 15.6, 31.3, 62.5, 125, 250, 500, 1000 μmol/l. Capsaicin concentration eliciting at least 2 coughs (C2) or 5 coughs (C5) is determined. At least 1-hour-interval from capsaicin dose titration (in order to minimize tachyphylaxy) Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls (normal saline) in random order at baseline At least 1-hour-interval (in order to minimize tachyphylaxy) Administration of 4 inhalations at 1-min-interval: 2 C5 and 2 controls in random order during exercise, when heart rate is maximum |
Who may qualify
- Ages
- 7 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Obtaining of informed consent (or informed consent of parents or persons with parental authority)
- Affiliation to social security
- Negative answer to all 12 questions of medical questionnaire for child or to all 11 questions of medical questionnaire for adult
- Normal cardio-respiratory examination
- Normal electrocardiogram
Key exclusion criteria (1 listed)
- Refusal or impossibility of obtaining informed consent of person or of persons with parental authority)
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 |
|---|---|---|
| Exercise6 min running on a motor-driven tredmill in a climate room (18-20°C, humidity <10 mg/l). Tredmill speed and slope are adjusted to increase heart rate to about 80 % of maximum value predicted for age (= 210 - age in years) during the first 2-3 min and pursued until the end of exercise (3-4 min). Heart rate is measured during the whole exercise. | Behavioural | Adults, Children |
| CapsaicinA compressed air-driven nebuliser is controlled by a dosimeter and a valve is used to deliver similar inspiratory flows for 400 msec in children and 1200 msec in adults. | Drug | Adults, Children |
| Normal salineA compressed air-driven nebuliser is controlled by a dosimeter and a valve is used to deliver similar inspiratory flows for 400 msec in children and 1200 msec in adults. | Drug | Adults, Children |
Primary outcome
Number of cough efforts occurring within 15 sec of the C5 aerosol at baseline and during exercise
Time frame: day 0
Video-taped and identified from its sound by 2 observers
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 30 Aug 2016.
- Individual participant dataSharing planned: No
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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 MARCHAL, Pr principal investigator
Explorations fonctionnelles pédiatriques, Hôpital d'enfants, CHRU de Nancy, France
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Capsaicin and Normal saline in people with Cough, run by Central Hospital, Nancy, 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 6 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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of cough efforts occurring within 15 sec of the C5 aerosol at baseline and during exercise (time frame: day 0). 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 30 Aug 2016.