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

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

Study Overview

• Status: Completed
• Conditions: Efficacy, Self
• Intervention / Treatment: Drug: Allergen Immunotherapy Extract

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35511
    • Mansoura University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sublingual immunotherapy; 50 Bronchial asthma (BA) patients received Sublingual immunotherapy	Drug: Allergen Immunotherapy Extract; Sublingual subcutaneous allergen immunotherapy; Other Names: allergen immunotherapy vaccines
Active Comparator: Subcutaneous immunotherapy; 50 BA patients received Subcutaneous immunotherapy	Drug: Allergen Immunotherapy Extract; Sublingual subcutaneous allergen immunotherapy; Other Names: allergen immunotherapy vaccines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Ig E	Measure Total igE after 6 months post immunotherapy	After 6 month
Total Ig E	Measure Total igE after 12 months post immunotherapy	After 12 month
Total Ig E	Measure Total igE after 18 months post immunotherapy	After18 month
Sputum eosinophil	Measure Sputum eosinophil after 6 months post immunotherapy	After 6 month
Sputum eosinophil	Measure Sputum eosinophil after 12 months post immunotherapy	After 12 month
Sputum eosinophil	Measure Sputum eosinophil after 18 months post immunotherapy	After 18 month

Collaborators and Investigators

• Sponsor: Mansoura University Hospital
• Investigators: Principal Investigator: Mohamed A Elmoniem, Mansoura University Faculty of Medicine

Publications and helpful links

General Publications

• 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 controlled trial. Clin Exp Allergy. 2010 Jun;40(6):922-32. doi: 10.1111/j.1365-2222.2009.03448.x. Epub 2010 Jan 20.
• 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, Fox AT, van Wijk RG, Gomez RM, Haathela T, Halken S, Hellings PW, Jacobsen L, Just J, Tanno LK, Kleine-Tebbe J, Klimek L, Knol EF, Kuna P, Larenas-Linnemann DE, Linneberg A, Matricardi M, Malling HJ, Moesges R, Mullol J, Muraro A, Papadopoulos N, Passalacqua G, Pastorello E, Pfaar O, Price D, Del Rio PR, Rueff R, Samolinski B, Scadding GK, Senti G, Shamji MH, Sheikh A, Sisul JC, Sole D, Sturm GJ, Tabar A, Van Ree R, Ventura MT, Vidal C, Varga EM, Worm M, Zuberbier T, Bousquet J. Allergy immunotherapy across the life cycle to promote active and healthy ageing: from research to policies: An AIRWAYS Integrated Care Pathways (ICPs) programme item (Action Plan B3 of the European Innovation Partnership on active and healthy ageing) and the Global Alliance against Chronic Respiratory Diseases (GARD), a World Health Organization GARD research demonstration project. Clin Transl Allergy. 2016 Nov 23;6:41. doi: 10.1186/s13601-016-0131-x. eCollection 2016.
• 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.
• 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.
• 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. doi: 10.1067/mai.2002.121460.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: subcutaneous; allergen immunotherapy; Sublingual
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Immunologic Factors
• Other Study ID Numbers: MD.21.09.522.R1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No