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

Efficacy, Self Clinical Trial

— Sublingual  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05786638
• Other study ID #: MD.21.09.522.R1
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2023
• Source: Mansoura University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 10, 2023
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Efficacy, Self

Intervention

Drug:
• Allergen Immunotherapy Extract
Sublingual subcutaneous allergen immunotherapy

Locations

Country	Name	City	State
Egypt	Mansoura university Faculty of medicine	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Calderon MA, Demoly P, Casale T, Akdis CA, Bachert C, Bewick M, Bilo BM, Bohle B, Bonini S, Bush A, Caimmi DP, Canonica GW, Cardona V, Chiriac AM, Cox L, Custovic A, De Blay F, Devillier P, Didier A, Di Lorenzo G, Du Toit G, Durham SR, Eng P, Fiocchi A, F — View Citation

Eifan AO, Akkoc T, Yildiz A, Keles S, Ozdemir C, Bahceciler NN, Barlan IB. Clinical efficacy and immunological mechanisms of sublingual and subcutaneous immunotherapy in asthmatic/rhinitis children sensitized to house dust mite: an open randomized control — View Citation

Fan TC, Chang HT, Chen IW, Wang HY, Chang MD. A heparan sulfate-facilitated and raft-dependent macropinocytosis of eosinophil cationic protein. Traffic. 2007 Dec;8(12):1778-1795. doi: 10.1111/j.1600-0854.2007.00650.x. Epub 2007 Oct 15. — View Citation

Kundig TM, Bachmann MF. Allergen-specific immunotherapy: regulatory T cells or allergen-specific IgG? Hum Vaccin. 2010 Aug;6(8):673-5. doi: 10.4161/hv.6.8.12007. No abstract available. — View Citation

Trautmann A, Schmid-Grendelmeier P, Kruger K, Crameri R, Akdis M, Akkaya A, Brocker EB, Blaser K, Akdis CA. T cells and eosinophils cooperate in the induction of bronchial epithelial cell apoptosis in asthma. J Allergy Clin Immunol. 2002 Feb;109(2):329-37 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Ig E	Measure Total igE after 6 months post immunotherapy	After 6 month
Primary	Total Ig E	Measure Total igE after 12 months post immunotherapy	After 12 month
Primary	Total Ig E	Measure Total igE after 18 months post immunotherapy	After18 month
Primary	Sputum eosinophil	Measure Sputum eosinophil after 6 months post immunotherapy	After 6 month
Primary	Sputum eosinophil	Measure Sputum eosinophil after 12 months post immunotherapy	After 12 month
Primary	Sputum eosinophil	Measure Sputum eosinophil after 18 months post immunotherapy	After 18 month