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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