A novel class of regulators: the potential of IL-10 producing B cells in decreasing allergic inflammation in asthmatic patients.

Completed

• Conditions: 10001708; allergy; asthma; 10006436

• Registration Number: NL-OMON43781
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

General inclusion criteria:
- Written informed consent
- Male and female persons, aged >= 18 years and <= 55 years;Specific inclusion criteria:
Group 1 (allergic rhinitis):
- moderate/severe allergic rhinitis (ARIA guidelines)
- PC20 of histamine > 16 mg/ml
- specific IgE >= 0.7 kU/l for tree or grass pollen and/or house dust mite (HDM)
- positive skin prick test response ( wheal > 5 mm) for tree or grass pollen and/or HDM
- total IgE >30 < 700 Iu/ml;Group 2 (allergic asthma):
- Clinical controlled asthma for at least 6 months according GINA guidelines, without severe exacerbations in the previous 6 months
- FEV1> 70% (short-acting β2-agonists if needed)
- History of episodic symptoms of wheezing, breathlessness, cough or chest tightness (>12 months)
- PC20 of histamine < 8 mg/ml
- a positive skin prick test response ( wheal > 5 mm) for tree or grass pollen and/or HDM
- specific IgE >= 0.7 kU/l for tree or grass pollen and/or house dust mite (HDM)
- total IgE >30 < 700 IU/ml;Group 3(healthy control group):
- negative SPT
- PC20 of histamine > 16 mg/ml
- Specific IgE < 0.7 kU/l for tree or grass pollen and/or house dust mite (HDM)
- Total IgE <100 IU/ml

Exclusion Criteria

age < 18 yrs
smoking
pregnancy
airway infection
Severe/ instable chronic asthma
Specific IgE >= 0.7 kU/l for animals to which the patients has daily contact with
Immunotherapy for the last 5 years
Anatomical abnormalities of the nose
Contraindications for immunotherapy according to international guidelines
anti-IgE treatment previously
systemic steroids or suffered exacerbations in the last year

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>IL-10 producing B cells in PBMC<br /><br>IL-4 producing T cells (Th2 cells) in reaction to relevant allergens</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Total IgE and allergen-specific IgE, IgG1, IgG2a, IgG4, IgA in plasma and nose<br /><br>washings.<br /><br>Affinity of allergen-specific IgE molecules<br /><br>TNFalpha and IL-10 in plasma and nose washings.<br /><br>Molecular profiling of B cell populations with ATACseq</p><br>