Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children

NCT ID: NCT02809560

Last Updated: 2016-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-05-31

Brief Summary

Asthma affects about 10% of children and 6% of adults in industrialized countries. Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are broadly involved in this pathology in experimental models and in humans. Many studies show that the signaling pathways activated by the commitment of T receiver differ depending LT. The identification of specific signaling pathways links to Th2 offer new therapeutic approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium channels sensitive channels Cav1 voltage, normally found in excitable cells where they are defined as receivers dihydropyridine (DHP).

The goal of the present study is to show the presence of Cav1 channels in inflammatory cells in allergic asthmatics and show overexpression of these channels in the peripheral blood mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in comparison with controls.

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Asthmatic children

Induced sputum method using hypertonic serum

Group Type: EXPERIMENTAL

Induced sputum method using hypertonic serum

Intervention Type: PROCEDURE

Collection of expectoration in sterile vial, conserved in ice all along the examination

Control children

Induced sputum method using hypertonic serum

Group Type: SHAM_COMPARATOR

Induced sputum method using hypertonic serum

Intervention Type: PROCEDURE

Collection of expectoration in sterile vial, conserved in ice all along the examination

Interventions

Induced sputum method using hypertonic serum

Collection of expectoration in sterile vial, conserved in ice all along the examination

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

For Asthmatic children arm :

• Girl not in childbearing potential or taking contraceptive treatment
• Asthma diagnosis in at least 6 months as defined by clinical symptoms (expiratory dyspnea, wheezing, sibilance) and respiratory function (reversibility of VEMS at least 12% after salbutamol administration)
• Allergologic tests positives to airborne allergens : positive prick test and/or specific IgE > 0,35 kU/L for at least one allergen
• Asthma severity between mild to moderate based on Global initiative for asthma classification during more than one month with inhaled corticotherapies +/- long term action beta -mimetic long compounds (salmeterol, formoterol)
• Patient insured with a social security scheme

For control children arm :

• Girl not in childbearing potential or taking contraceptive treatment
• No medical history of asthma
• No medical history of allergy or symptoms of allergy on skin (atopic dermatitis), respiratory tract (rhino-conjunctivitis, asthma) or food allergy

Exclusion Criteria

For both arms:

• Chronic respiratory pathology : known occlusive or restrictive respiratory syndrome like interstitial lung disease, neuromuscular disease, mucoviscidoses, respiratory tract abnormalities with cough, dyspnea or digital hippocratism.
• History of pulmonary or nose and throat infectious disease during last 4 months
• Parasitic disease non treated during last 3 months
• Dyspnea during the inclusion
• Systemic corticotherapy during the last 3 months before inclusion
• Immunosuppressive therapy during the last 3 months before inclusion
• Diabeta
• Disease causing immune disorder
• Infection during inclusion
• Participation to another study witch implies medical treatment during last 3 months before inclusion

For asthmatic children arm :

• Chronic pulmonary pathology (excluding asthma)
• Asthma exacerbation during inclusion
• VEMS < 70% of normal range or VEMS < 70% of normal range after inhalation of serum (despite salbutamol administration)
• Patient unable to complete pulmonary function testing

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Brémont, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital des Enfants CHU Toulouse

Other Identifiers

11 054 03

Identifier Type: -

Identifier Source: org_study_id