Skip to main content
OpenTrials
Completed

NCT Number: NCT05786638

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Efficacy, Self

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university Faculty of medicine

Al Mansurah, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allergen Immunotherapy Extract

Drug

Sublingual subcutaneous allergen immunotherapy

Primary outcomes

  1. Total Ig E

    Time frame: After 6 month

    Measure Total igE after 6 months post immunotherapy

  2. Total Ig E

    Time frame: After 12 month

    Measure Total igE after 12 months post immunotherapy

  3. Total Ig E

    Time frame: After18 month

    Measure Total igE after 18 months post immunotherapy

  4. Sputum eosinophil

    Time frame: After 6 month

    Measure Sputum eosinophil after 6 months post immunotherapy

  5. Sputum eosinophil

    Time frame: After 12 month

    Measure Sputum eosinophil after 12 months post immunotherapy

  6. Sputum eosinophil

    Time frame: After 18 month

    Measure Sputum eosinophil after 18 months post immunotherapy

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Acronym: Sublingual

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 27, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.