Effect of Muscular Exercise on Cough Reflex

Cough Clinical Trial

— REFLEXE TOUX  

Official title:

Effect of Muscular Exercise on Cough Reflex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882555
• Other study ID #: 2009-A00390-57
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: August 24, 2016
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 77 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cough

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No