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Completed

NCT Number: NCT02882555

Effect of Muscular Exercise on Cough Reflex

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.

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Key information

Age range

7 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Behavioral

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

Drug

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

Drug

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: REFLEXE TOUX

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2016
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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