Back to resultsDetection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children (CAVASTHME)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Induced sputum method using hypertonic serum
Sponsored by
About this trial
This is an interventional basic science trial for Asthma focused on measuring Lymphocytes Th2, Cav1 channels
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Asthmatic children
Control children
Arm Description
Induced sputum method using hypertonic serum
Induced sputum method using hypertonic serum
Outcomes
Primary Outcome Measures
Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction
Secondary Outcome Measures
Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection
Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection
Comparison of CRTH2+ cells in total blood between asthmatic and control group
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation
Full Information
NCT ID
NCT02809560
First Posted
May 17, 2016
Last Updated
June 17, 2016
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02809560
Brief Title
Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children
Acronym
CAVASTHME
Official Title
Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Lymphocytes Th2, Cav1 channels
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthmatic children
Arm Type
Experimental
Arm Description
Induced sputum method using hypertonic serum
Arm Title
Control children
Arm Type
Sham Comparator
Arm Description
Induced sputum method using hypertonic serum
Intervention Type
Procedure
Intervention Name(s)
Induced sputum method using hypertonic serum
Intervention Description
Collection of expectoration in sterile vial, conserved in ice all along the examination
Primary Outcome Measure Information:
Title
Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection
Time Frame
Day 1
Title
Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection
Time Frame
Day 1
Title
Comparison of CRTH2+ cells in total blood between asthmatic and control group
Time Frame
Day 1
Title
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation
Time Frame
Day 1
Title
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Brémont, MD
Organizational Affiliation
Hôpital des Enfants CHU Toulouse
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children
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