Clinical trial NCT05786638: Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma
Official title: Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy, Self
Keywords: Sublingual
subcutaneous
allergen immunotherapy
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sublingual versus subcutaneous allergen immunotherapy
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Ig E
timeFrame: After 6 month
measure: Total Ig E
timeFrame: After 12 month
measure: Total Ig E
timeFrame: After18 month
measure: Sputum eosinophil
timeFrame: After 6 month
measure: Sputum eosinophil
timeFrame: After 12 month
measure: Sputum eosinophil
timeFrame: After 18 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university Faculty of medicine
Study officials:
affiliation: Mansoura university Faculty of medicine
name: Mohamed A Elmoniem
role: PRINCIPAL_INVESTIGATOR
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