Total IgE (Immunoglobulin E) and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma

Study Overview
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Brief Summary
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Asthma is a heterogeneous disease, and specifically the phenotype of non-allergic asthma is not yet well defined. Several studies describe this group of patients as having severe asthma, persistent eosinophilia and poor therapeutic response. Among the theories being considered is the role of local IgE. Objectives: 1) To perform a pilot test to validate the measurement technique and standardize the levels of total IgE and IgE specific to Dermatophagoides pteronyssinus (d1) in the induced sputum of asthmatic patients and healthy volunteers. 2) Correlate local total IgE and specific IgE levels to d1 (sputum and peripheral blood) in patients with allergic and non-allergic asthma. 3) Describe the clinical and inflammatory characteristics of patients with allergic and non-allergic asthma.

Detailed Description
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Comparative cross-sectional study. It will include 32 allergic and non-allergic asthma patients and 10 healthy volunteers. All patients will have an induced sputum, pulmonary function studies, FENO (exhaled fraction of nitric oxide), total and specific IgE measurement at d1 (the most common perennial pneumoallergen) in blood and induced sputum, as well as a prick skin test with standardized allergen extracts. Measurement of total IgE and IgE for d1 in induced sputum will be performed in the supernatant and by the ImmunoCAP (Phadia ThermoFisher Scientific) immunofluoroassay technique.

Official Title
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Total IgE and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Induced Sputum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 Asthma according to GEMA (spanish asthma guideline) Exclusion Criteria: Pregnancy Active smoking Moderate alcohol consumption Atopic dermatitis Other respiratory disease different than asthma (COPD, bronchiectasis, cystic fibrosis, pleural disease, interstitial disease) Treatment with steroids or inmunodepressants Active malignancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>Healthy controls, without asthma or allergy (negative prick test) | Behavioral: Induced Sputum<br>* Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum<br>|
| Allergic asthma<br>Patients with allergic asthma sensitized to Dermatophagoides pteronyssinus, tested by prick test or specific IgE | Behavioral: Induced Sputum<br>* Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum<br>|
| Non-allergic asthma<br>Patients with asthma not sensitized to Dermatophagoides pteronyssinus, with negative prick test or specific IgE | Behavioral: Induced Sputum<br>* Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of specific IgE | Detection of high levels or not of specific IgE in induced sputum | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of total IgE | Detection of high levels or not of total IgE in induced sputum | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, allergy, specific IgE