Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma (PEGASE2)

October 31, 2022 updated by: Assistance Publique - Hôpitaux de Paris
This study is designed to investigate whether the Phosphodiesterase 4 gene variability could be implicated in the salbutamol responsiveness in asthmatic children.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker -Enfants Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0
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.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 25, 2018

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (ACTUAL)

July 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI16014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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