Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma

NCT03592212 | Terminated

• 1 other identifier: NI16014
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Locating other regions of the PDE4 gene that may be associated with the response to salbutamol by gene mapping (using SNP tags)

  Day 0

• Screening other SNPs (other genes than PDE4) associated with the response to salbutamol in childhood asthma using SNP tags

  Day 0

Interventions

Salbutamol DRUG

Measurement of bronchodilator response (BDR)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children 6-18 years old asthmatic patients consulting in the Department of Pediatric Pulmonology and Allergy of Necker University Hospital.

You may qualify if:

• 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

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Necker -Enfants Malades

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva from patients will be collected using Oragen®. DNA OG-575 kit, (DNA Genotek, Kanata, Canada) and stored at room temperature.

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Guillaume LEZMI, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: July 19, 2018
• Study Start: November 23, 2018
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)