Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis

Completed

• Conditions: Asthma

• Registration Number: NCT02195258
• Lead Sponsor: Hôpital Necker-Enfants Malades

Brief Summary

this study is designed to identify the genetic factors which can be implicated in the salbutamol responsiveness for asthmatic children in pediatric emergency department

Detailed Description

Patients from 6 to 16 years old consulting for an acute asthma exacerbation and receiving a treatment by salbutamol according to the usual care could be recruited.Saliva from patient were collected using Oragen®.DNA OG-500 kit or swabs.Based on literature review, four SNP were chosen:ADBR2 gene), ARG gene, and GSNOR gene.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2012-05
• Study Completion: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2014-07-17
• Last Update Submitted: 2014-07-17
• Study First Posted: 2014-07-21
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• children
• 6-16 years old
• asthmatic patients
• consulting for an exacerbation in a pediatric emergency department
• parental informed consent

Exclusion Criteria

• comorbidity
• peak flow no available
• pneumonia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1)	Day 0	comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator FEV1 value (BDR = 100 x \[post-FEV1 - pre-FEV1\]/pre-FEV1) between the different polymorphism

Secondary Outcome Measures

Name	Time	Method
polymorphism on the response delay	Day 0

Trial Locations

Locations (1)

Necker Enfants Malades Hospital; 🇫🇷 Paris, France