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Efficacy, SelfSublingualNCT05786638

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

A study testing Allergen Immunotherapy Extract in people with Efficacy, Self, run by Mansoura University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Efficacy, Self
What is being tested?
Allergen Immunotherapy Extract
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
20 Oct 2021to 10 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Mansoura university Faculty of medicine

    Al Mansurah, 35511

Other trials in Egypt

About this study

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.

Read more

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

Read the 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.

Conditions
Efficacy, Self
Being tested
Allergen Immunotherapy Extract
Keywords
Sublingual, subcutaneous, allergen immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allergen Immunotherapy ExtractDrug

    Sublingual subcutaneous allergen immunotherapy

Study groups in NCT05786638
Study groupRoleWhat they receive
Sublingual immunotherapyActive comparator50 Bronchial asthma (BA) patients received Sublingual immunotherapy
Receives: Drug: Allergen Immunotherapy Extract
Subcutaneous immunotherapyActive comparator50 BA patients received Subcutaneous immunotherapy
Receives: Drug: Allergen Immunotherapy Extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Ig E

    Measure Total igE after 6 months post immunotherapy

    Measured: After 6 month

  2. Total Ig E

    Measure Total igE after 12 months post immunotherapy

    Measured: After 12 month

  3. Total Ig E

    Measure Total igE after 18 months post immunotherapy

    Measured: After18 month

  4. Sputum eosinophil

    Measure Sputum eosinophil after 6 months post immunotherapy

    Measured: After 6 month

  5. Sputum eosinophil

    Measure Sputum eosinophil after 12 months post immunotherapy

    Measured: After 12 month

  6. Sputum eosinophil

    Measure Sputum eosinophil after 18 months post immunotherapy

    Measured: After 18 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study start20 Oct 2021
  3. Primary completion10 Oct 2022
  4. Study completion10 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Sublingual versus subcutaneous allergen immunotherapy
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05786638
Sponsor's protocol ID
MD.21.09.522.R1
Acronym
Sublingual
Status last verified
Mar 2023
First submitted
13 Mar 2023
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 20100188

  • 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.

    PubMed 27895895

  • 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.

    PubMed 17944807

  • 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.

    PubMed 20523122

  • 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.

    PubMed 11842305

Questions about this trial

What is this clinical trial studying?

A study testing Allergen Immunotherapy Extract in people with Efficacy, Self, run by Mansoura University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Ig E (time frame: After 6 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05786638, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

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