Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma

Study Overview
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Brief Summary
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Asthma is characterized by airway inflammation and is manifested by acute episodes of obstruction related to loss of control of airway inflammation mostly in response to a viral respiratory tract infection .The significance of eosinophilic inflammation in asthma is well established. Late clinical reactions in asthma are associated with increase of immunoglobulin E (IgE) in serum. Serum IgE can be used as a measure of allergen provocation causing increased eosinophil activity. Serum IgE can be used to assess the exposure to environmental allergens, or decreasing presence of allergen in the environment and the need for increase or reduction of therapy. Allergen immunotherapy is defined as the repeated administration of specific allergens to patients with IgE-mediated conditions for the purpose of providing protection against the allergic symptoms and inflammatory reactions associated with natural exposure to these allergens. The aim of this work is to evaluate the effect of sublingual versus subcutaneous allergen immunotherapy as regard clinical response, serum IgE and sputum eosinophils

Detailed Description
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study was conducted in Mansoura University Hospitals, Chest Medicine Department on patients attended to Asthma and Allergy clinic. The asthma symptoms and leukotrienes antagonist, inhaled B2 agonist, inhaled steroid and systemic steroid usage recorded throughout the study period. Venous blood and sputum samples were collected before and at the end of the study for determination of IgE and sputum eosinophil levels respectively. Fifty asthmatic patients recruited from Mansoura university allergy outpatient clinic were included before treatment with subcutaneous immunotherapy (SCIT) vaccines and another Fifty asthmatic patients were included before treatment with sublingual immunotherapy (SLIT) vaccines. In this study, All of patients were symptomatic and on medications either bronchodilators or inhaled corticosteroids (ICS). All patients were diagnosed by previous pulmonary function test (PFT) with reversibility test and follow up with our outpatient clinic (OPC). Each patient underwent spirometry to determine forced expiratory volume at 1st second (FEV1) and to ensure that his condition is stable before starting immunotherapy. Serum IgE and sputum eosinophil count were measured in 100 patients with asthma before and after 6 , 12 , 18 months of treatment with immunotherapy vaccines.

Official Title
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Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma

Conditions
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Efficacy, Self

Intervention / Treatment
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* Drug: Allergen Immunotherapy Extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New cases of allergic asthma indicated for immunotherapy (partially controlled by medical treatment with frequent exacerbations) Age >18 years Exclusion Criteria: Pregnancy Co morbidity such as diabetes, hypertension, ischemic heart, malignancy Other causes of the increase in eosinophil as: parasitic infestation Acute exacerbation of BA Smoker Severe persistent asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sublingual versus subcutaneous allergen immunotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sublingual immunotherapy<br>50 Bronchial asthma (BA) patients received Sublingual immunotherapy | Drug: Allergen Immunotherapy Extract<br>* Sublingual subcutaneous allergen immunotherapy<br>|
| Active Comparator: Subcutaneous immunotherapy<br>50 BA patients received Subcutaneous immunotherapy | Drug: Allergen Immunotherapy Extract<br>* Sublingual subcutaneous allergen immunotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Ig E | Measure Total igE after 6 months post immunotherapy | After 6 month | 
| Total Ig E | Measure Total igE after 12 months post immunotherapy | After 12 month | 
| Total Ig E | Measure Total igE after 18 months post immunotherapy | After18 month | 
| Sputum eosinophil | Measure Sputum eosinophil after 6 months post immunotherapy | After 6 month | 
| Sputum eosinophil | Measure Sputum eosinophil after 12 months post immunotherapy | After 12 month | 
| Sputum eosinophil | Measure Sputum eosinophil after 18 months post immunotherapy | After 18 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sublingual, subcutaneous, allergen immunotherapy