Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children

NCT02809560 | Completed

• 1 other identifier: 11 054 03
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

Lymphocytes Th2; Cav1 channels

Outcome Measures

Primary Outcomes (1)

• Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction

  Day 1

Secondary Outcomes (5)

• Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection

  Day 1

• Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection

  Day 1

• Comparison of CRTH2+ cells in total blood between asthmatic and control group

  Day 1

• Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation

  Day 1

• Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation

  Day 1

Study Arms (2)

Asthmatic children

EXPERIMENTAL

Induced sputum method using hypertonic serum

Procedure: Induced sputum method using hypertonic serum

Control children

SHAM COMPARATOR

Induced sputum method using hypertonic serum

Procedure: Induced sputum method using hypertonic serum

Interventions

Induced sputum method using hypertonic serum PROCEDURE

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

Asthmatic children; Control children

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Diabeta
• Disease causing immune disorder
• For asthmatic children arm :
• Chronic pulmonary pathology (excluding asthma)
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• François Brémont, MD

  Hôpital des Enfants CHU Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 22, 2016
• Study Start: March 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share