Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis

Asthma Clinical Trial

— Pegase  

Official title:

Pharmacogenetic of the Salbutamol Efficacy in Asthma Crisis for Children in Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195258
• Other study ID #: URC Paris centre
• Status: Completed
• Phase: N/A
• First received: July 4, 2013
• Last updated: July 17, 2014
• Start date: November 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Hôpital Necker-Enfants Malades
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
France	Necker Enfants Malades Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1)	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	Day 0	No
Secondary	polymorphism on the response delay		Day 0	No