Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03592212

Acronym

PEGASE2

Enrollment

Registered

2018-07-19

Start date

2018-11-23

Completion date

2019-11-14

Last updated

2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Salbutamol response, Phosphodiesterase 4 variant, lung function, airflow limitation

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.

Interventions

DRUGSalbutamol

Measurement of bronchodilator response (BDR)

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGuillaume LEZMI, MD, PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026