Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Sublingual immunotherapy 50 Bronchial asthma (BA) patients received Sublingual immunotherapy |
Drug: Allergen Immunotherapy Extract
Sublingual subcutaneous allergen immunotherapy
|
| Active Comparator: Subcutaneous immunotherapy 50 BA patients received Subcutaneous immunotherapy |
Drug: Allergen Immunotherapy Extract
Sublingual subcutaneous allergen immunotherapy
|
Outcome Measures
Primary Outcome Measures
- Total Ig E [After 6 month]
Measure Total igE after 6 months post immunotherapy
- Total Ig E [After 12 month]
Measure Total igE after 12 months post immunotherapy
- Total Ig E [After18 month]
Measure Total igE after 18 months post immunotherapy
- Sputum eosinophil [After 6 month]
Measure Sputum eosinophil after 6 months post immunotherapy
- Sputum eosinophil [After 12 month]
Measure Sputum eosinophil after 12 months post immunotherapy
- Sputum eosinophil [After 18 month]
Measure Sputum eosinophil after 18 months post immunotherapy
Eligibility Criteria
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
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Acute exacerbation of BA
-
Smoker
-
Severe persistent asthma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mansoura university Faculty of medicine | Mansoura | Egypt | 35511 |
Sponsors and Collaborators
- Mansoura University Hospital
Investigators
- Principal Investigator: Mohamed A Elmoniem, Mansoura university Faculty of medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MD.21.09.522.R1