Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02877537

Acronym

SALBUTAMOL

Enrollment

177

Registered

2016-08-24

Start date

2008-10-31

Completion date

2012-04-30

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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.

Interventions

DRUGSalbutamol

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

PROCEDUREForced oscillation technique

before and after bronchodilation

PROCEDUREPlethysmography

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Ventilatory mechanical impedance	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
Thoracic gas volume	day 0	Measured with Plethysmography.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026