Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children

Asthma Clinical Trial

— CAVASTHME  

Official title:

Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809560
• Other study ID #: 11 054 03
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: June 17, 2016
• Start date: March 2013
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Induced sputum method using hypertonic serum
Collection of expectoration in sterile vial, conserved in ice all along the examination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction		Day 1	No
Secondary	Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection		Day 1	No
Secondary	Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection		Day 1	No
Secondary	Comparison of CRTH2+ cells in total blood between asthmatic and control group		Day 1	No
Secondary	Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation		Day 1	No
Secondary	Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation		Day 1	No