Effect of Muscular Exercise on Cough Reflex (REFLEXE TOUX)

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.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Behavioral: Exercise; Drug: Capsaicin; Drug: Normal saline

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 77 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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%)

Exclusion Criteria:

• Refusal or impossibility of obtaining informed consent of person or of persons with parental authority)

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Behavioral: 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.; Drug: 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.; Drug: 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.
ACTIVE_COMPARATOR: 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	Behavioral: 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.; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	day 0

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: François MARCHAL, Pr, Explorations fonctionnelles pédiatriques, Hôpital d'enfants, CHRU de Nancy, France

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (ESTIMATE): August 30, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: 2009-A00390-57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO