Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma

Overview

This study is designed to investigate whether the Phosphodiesterase 4 gene variability could be implicated in the salbutamol responsiveness in asthmatic children.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: March 2023

Detailed Description

Patients from 6 to 18 years old with asthma and receiving a treatment by salbutamol according to the usual care will be recruited. Saliva from patients will be collected using Oragen®.DNA OG-575 kit.

Interventions

  • Drug: Salbutamol
    • Measurement of bronchodilator response (BDR)

Clinical Trial Outcome Measures

Primary Measures

  • pre- and post-bronchodilator VEMS value
    • Time Frame: Day 0
    • comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator VEMS value (BDR = 100 x [post-VEMS – pre-VEMS]/pre-VEMS) according to the genotype of the rs1504982

Secondary Measures

  • Locating other regions of the PDE4 gene that may be associated with the response to salbutamol by gene mapping (using SNP tags)
    • Time Frame: Day 0
    • To identify other SNPs on PDE4 associated with the response (BDR) to salbutamol in childhood asthma.
  • Screening other SNPs (other genes than PDE4) associated with the response to salbutamol in childhood asthma using SNP tags
    • Time Frame: Day 0
    • To identify other genes that could be associated with the phenotype of interest (BDR) by tagging other genes.

Participating in This Clinical Trial

Inclusion Criteria

  • Children 6-18 years – Asthma: confirmed asthma symptoms (wheeze, cough, dyspnea, chest tightness) and evidence for variable airflow limitation (≥ 12% increase in post bronchodilator FEV1, or ≥ 20% decrease in FEV1 post methacholine) – Spirometry prescribed for follow-up – Airflow limitation: FEV1<80% and/or FEV1/FVC <80 pre-bronchodilator Exclusion Criteria:

  • no exclusion criteria

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Guillaume LEZMI, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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