Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma

Active, not recruiting

• Conditions: Asthma

• Registration Number: NCT03592212
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Study Start: 2018-11-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pre- and post-bronchodilator VEMS value	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 Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Necker -Enfants Malades; 🇫🇷 Paris, France