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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592212
Recruitment Status : Unknown
Verified January 2019 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : July 19, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment
Asthma Drug: Salbutamol

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 Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma
Actual Study Start Date : November 25, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

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Groups and Cohorts
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Intervention Details:
  • Drug: Salbutamol
    Measurement of bronchodilator response (BDR)

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


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.

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592212


Contacts
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Contact: Guillaume LEZMI, MD, PhD +33 1 44 49 48 38 guillaume.lezmi@aphp.fr
Contact: Sandra COLAS +33 1 71 19 64 32 sandra.colas@aphp.fr

Locations
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France
Hôpital Necker -Enfants Malades Recruiting
Paris, France, 75015
Contact: Guillaume LEZMI, MD, PhD    +33 1 44 49 48 38    guillaume.lezmi@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Guillaume LEZMI, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03592212    
Other Study ID Numbers: NI16014
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Asthma
Salbutamol response
Phosphodiesterase 4 variant
lung function
airflow limitation
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action