Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma
- Conditions
- Efficacy, Self
- Interventions
- Drug: Allergen Immunotherapy Extract
- Registration Number
- NCT05786638
- Lead Sponsor
- Mansoura University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- New cases of allergic asthma indicated for immunotherapy (partially controlled by medical treatment with frequent exacerbations)
- Age >18 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sublingual immunotherapy Allergen Immunotherapy Extract 50 Bronchial asthma (BA) patients received Sublingual immunotherapy Subcutaneous immunotherapy Allergen Immunotherapy Extract 50 BA patients received Subcutaneous immunotherapy
- Primary Outcome Measures
Name Time Method Total Ig E After18 month Measure Total igE after 18 months post immunotherapy
Sputum eosinophil After 18 month Measure Sputum eosinophil after 18 months post immunotherapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mansoura university Faculty of medicine
🇪🇬Mansoura, Egypt