Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma (Sublingual)
Primary Purpose
Efficacy, Self
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Allergen Immunotherapy Extract
Sponsored by
About this trial
This is an interventional treatment trial for Efficacy, Self focused on measuring Sublingual, subcutaneous, allergen immunotherapy
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
Sites / Locations
- Mansoura university Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sublingual immunotherapy
Subcutaneous immunotherapy
Arm Description
50 Bronchial asthma (BA) patients received Sublingual immunotherapy
50 BA patients received Subcutaneous immunotherapy
Outcomes
Primary Outcome Measures
Total Ig E
Measure Total igE after 6 months post immunotherapy
Total Ig E
Measure Total igE after 12 months post immunotherapy
Total Ig E
Measure Total igE after 18 months post immunotherapy
Sputum eosinophil
Measure Sputum eosinophil after 6 months post immunotherapy
Sputum eosinophil
Measure Sputum eosinophil after 12 months post immunotherapy
Sputum eosinophil
Measure Sputum eosinophil after 18 months post immunotherapy
Secondary Outcome Measures
Full Information
NCT ID
NCT05786638
First Posted
March 13, 2023
Last Updated
March 26, 2023
Sponsor
Mansoura University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05786638
Brief Title
Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma
Acronym
Sublingual
Official Title
Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
March 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Self
Keywords
Sublingual, subcutaneous, allergen immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sublingual versus subcutaneous allergen immunotherapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sublingual immunotherapy
Arm Type
Active Comparator
Arm Description
50 Bronchial asthma (BA) patients received Sublingual immunotherapy
Arm Title
Subcutaneous immunotherapy
Arm Type
Active Comparator
Arm Description
50 BA patients received Subcutaneous immunotherapy
Intervention Type
Drug
Intervention Name(s)
Allergen Immunotherapy Extract
Intervention Description
Sublingual subcutaneous allergen immunotherapy
Primary Outcome Measure Information:
Title
Total Ig E
Description
Measure Total igE after 6 months post immunotherapy
Time Frame
After 6 month
Title
Total Ig E
Description
Measure Total igE after 12 months post immunotherapy
Time Frame
After 12 month
Title
Total Ig E
Description
Measure Total igE after 18 months post immunotherapy
Time Frame
After18 month
Title
Sputum eosinophil
Description
Measure Sputum eosinophil after 6 months post immunotherapy
Time Frame
After 6 month
Title
Sputum eosinophil
Description
Measure Sputum eosinophil after 12 months post immunotherapy
Time Frame
After 12 month
Title
Sputum eosinophil
Description
Measure Sputum eosinophil after 18 months post immunotherapy
Time Frame
After 18 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Elmoniem
Organizational Affiliation
Mansoura university Faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university Faculty of medicine
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20100188
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 controlled trial. Clin Exp Allergy. 2010 Jun;40(6):922-32. doi: 10.1111/j.1365-2222.2009.03448.x. Epub 2010 Jan 20.
Results Reference
result
PubMed Identifier
27895895
Citation
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.
Results Reference
result
PubMed Identifier
17944807
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.
Results Reference
result
PubMed Identifier
20523122
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.
Results Reference
result
PubMed Identifier
11842305
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. doi: 10.1067/mai.2002.121460.
Results Reference
result
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Efficacy of Sublingual Versus Subcutaneous Allergen Immunotherapy in Patients With Bronchial Asthma
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