The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa

Study Overview
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Brief Summary
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Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is defined in the literature as asthma not controlled by medication. In recent years it has become known that severe asthma is a variable disease and has subtypes relating to the age of onset, type of inflammation and allergy, obesity, etc. Our aim is to characterize the phenotypes of severe asthma population in our clinic and compare the prevalent phenotypes to the phenotypes described before.

Detailed Description
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Study measures will include the following: asthma demographic and symptoms questionnaire Validation of proper inhaler technique Height, weight measurements Forced spirometry and reversibility testing DLCO Fractional excretion of NO in exhaled breath Chest and sinus CT Induced sputum analysis Complete blood count, electrolytes, immunoglobulin E, Aspergillus Specific IgE Skin allergy testing

Official Title
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The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa.

Conditions
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Asthma

Intervention / Treatment
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* Other: Severe Asthma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of Asthma- typical symptoms and signs accompanied by either: a. obstruction in Spirometry, OR- b. positive methacholine test Regular use of high dose of inhaled corticosteroids (1000 micrograms of fluticasone per day or equivalent) in addition to a long acting beta agonist (LABA). Lack of asthma control- 2 or more exacerbations in the past year- exacerbations defined by hospitalization or care in an emergency department or treatment with systemic glucocorticosteroids for exacerbation of asthma symptoms. Exclusion Criteria: Presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (COPD) lack of adherence to medical therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe Asthma<br>Patients with severe asthma as specified under inclusion, exclusion criteria | Other: Severe Asthma<br>* Demographic data, Spirometry, induced sputum, IgE, Aspergillus specific IgE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 second (FEV1) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon Monoxide Diffusion Capacity (DLCO) |  | 1 year | 
| Percent eosinophils in induced sputum sample |  | 1 year | 
| Bronchiectasis on computerized tomography (CT) |  | 1 year) | 
| Blood level of Total immunoglobulin E (IgE) |  | 1 year | 
| Presence of blood antibody to Aspergillus Fumigatus |  | 1 year | 
| Fraction of Nitric Oxide (NO) in expired air |  | 1 year |