Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis

Asthma Clinical Trial

— SALBUTAMOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877537
• Other study ID #: 2007-002822-31
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2016
• Last updated: August 19, 2016
• Start date: October 2008
• Est. completion date: April 2012

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salbutamol
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber

Procedure:
• Forced oscillation technique
before and after bronchodilation
• Plethysmography

Locations

Country	Name	City	State
France	CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilatory mechanical impedance	Measured with Forced oscillation technique. 2 measures at basal status at 10 min interval for reproducibility and after 10 min broncodilation with salbutamol	day 0	No
Primary	Thoracic gas volume	Measured with Plethysmography.	day 0	No