Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma

Asthma Clinical Trial

— PEGASE2  

Official title:

Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03592212
• Other study ID #: NI16014
• Status: Active, not recruiting
• Start date: November 25, 2018
• Est. completion date: March 2023

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salbutamol
Measurement of bronchodilator response (BDR)

Locations

Country	Name	City	State
France	Hôpital Necker -Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre- and post-bronchodilator VEMS value	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	Day 0
Secondary	Locating other regions of the PDE4 gene that may be associated with the response to salbutamol by gene mapping (using SNP tags)	To identify other SNPs on PDE4 associated with the response (BDR) to salbutamol in childhood asthma.	Day 0
Secondary	Screening other SNPs (other genes than PDE4) associated with the response to salbutamol in childhood asthma using SNP tags	To identify other genes that could be associated with the phenotype of interest (BDR) by tagging other genes.	Day 0