- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02809560
Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children (CAVASTHME)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Asthmatic children
Induced sputum method using hypertonic serum
|
Collection of expectoration in sterile vial, conserved in ice all along the examination
|
Sham-komparator: Control children
Induced sputum method using hypertonic serum
|
Collection of expectoration in sterile vial, conserved in ice all along the examination
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction
Tidsramme: Day 1
|
Day 1
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection
Tidsramme: Day 1
|
Day 1
|
Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection
Tidsramme: Day 1
|
Day 1
|
Comparison of CRTH2+ cells in total blood between asthmatic and control group
Tidsramme: Day 1
|
Day 1
|
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation
Tidsramme: Day 1
|
Day 1
|
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation
Tidsramme: Day 1
|
Day 1
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: François Brémont, MD, Hôpital des Enfants CHU Toulouse
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11 054 03
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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