Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis (SALBUTAMOL)

Central Hospital, Nancy, France

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Procedure: Plethysmography; Drug: Salbutamol; Procedure: Forced oscillation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02877537

2007-002822-31

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 3 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 3 patient groups

Asthma child

Experimental group

Treatment:

Procedure: Forced oscillation technique

Drug: Salbutamol

Procedure: Plethysmography

Control adult

Experimental group

Treatment:

Procedure: Forced oscillation technique

Drug: Salbutamol

Procedure: Plethysmography

Control child

Experimental group

Treatment:

Procedure: Forced oscillation technique

Drug: Salbutamol

Procedure: Plethysmography