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Completed

NCT Number: NCT02195258

Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Necker Enfants Malades Hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. polymorphism on the response delay

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Hôpital Necker-Enfants Malades

Other

Registry information

Official study title

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

Acronym: Pegase

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 21, 2014
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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