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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2023-03-10

Brief Summary

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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

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Detailed Description

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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

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Efficacy, Self

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sublingual versus subcutaneous allergen immunotherapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sublingual immunotherapy

50 Bronchial asthma (BA) patients received Sublingual immunotherapy

Group Type ACTIVE_COMPARATOR

Allergen Immunotherapy Extract

Intervention Type DRUG

Sublingual subcutaneous allergen immunotherapy

Subcutaneous immunotherapy

50 BA patients received Subcutaneous immunotherapy

Group Type ACTIVE_COMPARATOR

Allergen Immunotherapy Extract

Intervention Type DRUG

Sublingual subcutaneous allergen immunotherapy

Interventions

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Allergen Immunotherapy Extract

Sublingual subcutaneous allergen immunotherapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No