Clinical trial

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

Name
MD.21.09.522.R1
Description
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
Trial arms
Trial start
2021-10-20
Estimated PCD
2022-10-10
Trial end
2023-03-10
Status
Completed
Treatment
Allergen Immunotherapy Extract
Sublingual subcutaneous allergen immunotherapy
Arms:
Subcutaneous immunotherapy, Sublingual immunotherapy
Size
100
Primary endpoint
Total Ig E
After 6 month
Total Ig E
After 12 month
Total Ig E
After18 month
Sputum eosinophil
After 6 month
Sputum eosinophil
After 12 month
Sputum eosinophil
After 18 month
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sublingual versus subcutaneous allergen immunotherapy', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-03-28

1 organization

1 product

2 indications

Indication
efficacy
Indication
Self