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Completed

NCT Number: NCT02877537

Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis

The purpose is to characterize the change of respiratory admittance induced by salbutamol inhalation in children and young adults. A variation threshold will be fixed to distinguish asthmatic and healthy subjects.

This project could allow a better identification of asthmatic individuals needing a treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments administered in individuals with respiratory but not asthmatic symptoms, a better comprehension of bronchial hyperreactivity and its role in asthmatic disease.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

3 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Asthmatic children group:

  • Several episodes of paroxysmal wheezes, spontaneous or after exercise, without bronchial-pulmonary infection
  • Absence of bronchodilator taking during last 12 hours
  • Absence of reported intolerance to adrenergic substances
  • Parental authorization and consent of child to participate to the study

Control children group:

  • Parental authorization and consent of child to participate to the study

Control adult group:

  • Consent to participate to the study

Exclusion criteria

Control children and adult groups:

  • At least 2 episodes of wheezes during breathing
  • Several wheezes, abnormal breathlessness, cough during physical exercise
  • Asthma diagnosed by family doctor
  • Administration of drugs to treat asthma
  • Eczema or food allergy at inclusion
  • Episode of cough for longer than 6 weeks, without bronchial infection
  • Bronchitis, throat infection, rhino-pharyngitis during last 15 days
  • Paleness or cyanosis with loss of consciousness when the child was a baby or during an exercise

Treatment and study plan

Salbutamol

Drug

bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber

Other names: Ventoline

Forced Oscillation Technique

Procedure

before and after bronchodilation

Plethysmography

Procedure

Primary outcomes

  1. Ventilatory mechanical impedance

    Time frame: day 0

    Measured with Forced oscillation technique. 2 measures at basal status at 10 min interval for reproducibility and after 10 min broncodilation with salbutamol

  2. Thoracic gas volume

    Time frame: day 0

    Measured with Plethysmography.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Measurements of Change of Respiratory Admittance Induced by Salbutamol for Pediatric Asthma Diagnosis

Acronym: SALBUTAMOL

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 24, 2016
Registry last updated
Aug 24, 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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