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

NCT05786638 | Completed

• 1 other identifier: MD.21.09.522.R1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Efficacy, Self

Keywords

Sublingual; subcutaneous; allergen immunotherapy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Sublingual immunotherapy

ACTIVE COMPARATOR

50 Bronchial asthma (BA) patients received Sublingual immunotherapy

Drug: Allergen Immunotherapy Extract

Subcutaneous immunotherapy

ACTIVE COMPARATOR

50 BA patients received Subcutaneous immunotherapy

Drug: Allergen Immunotherapy Extract

Interventions

Allergen Immunotherapy Extract DRUG

Sublingual subcutaneous allergen immunotherapy

Subcutaneous immunotherapy; Sublingual immunotherapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• New cases of allergic asthma indicated for immunotherapy (partially controlled by medical treatment with frequent exacerbations)
• Age \>18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mansoura university Faculty of medicine

Al Mansurah, 35511, Egypt

Location

Related Publications (5)

• 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.

  PMID: 20100188 RESULT

• 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.

  PMID: 27895895 RESULT

• 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.

  PMID: 17944807 RESULT

• 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.

  PMID: 20523122 RESULT

• 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.

  PMID: 11842305 RESULT

MeSH Terms

Interventions

Desensitization, Immunologic

Intervention Hierarchy (Ancestors)

Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Mohamed A Elmoniem

  Mansoura university Faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Sublingual versus subcutaneous allergen immunotherapy

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 27, 2023
• Study Start: October 20, 2021
• Primary Completion: October 10, 2022
• Study Completion: March 10, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)