Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis (Pegase)

July 17, 2014 updated by: Helene Chappuy, Hôpital Necker-Enfants Malades

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Necker Enfants Malades hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
salbutamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1)
Time Frame: 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
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
polymorphism on the response delay
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Necker-Enfants Malades

Investigators

  • Principal Investigator: Hélène Chappuy, MDPhD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 17, 2014

First Posted (ESTIMATE)

July 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URC Paris centre

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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