Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2012-06-30
2013-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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Children
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
Exercise
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.
Capsaicin
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 saline
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.
Adults
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
Exercise
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.
Capsaicin
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 saline
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.
Interventions
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Exercise
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.
Capsaicin
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 saline
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.
Eligibility Criteria
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Inclusion Criteria
* 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%)
Exclusion Criteria
7 Years
77 Years
ALL
Yes
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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François MARCHAL, Pr
Role: PRINCIPAL_INVESTIGATOR
Explorations fonctionnelles pédiatriques, Hôpital d'enfants, CHRU de Nancy, France
Other Identifiers
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2009-A00390-57
Identifier Type: -
Identifier Source: org_study_id
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