Changes in Eosinophil Cationic Protein and Sputum Eosinophils Following Allergen Immunotherapy

Early Changes in Eosinophil Cationic Protein and Sputum Eosinophils Following Subcutaneous Allergen Immunotherapy in Allergic Asthma: A Prospective Cohort Study

Asthma is a chronic heterogeneous inflammatory airway disease affecting millions worldwide and remains a major global health burden. Despite advances in pharmacological therapy, a substantial proportion of patients continue to experience uncontrolled symptoms due to persistent airway inflammation and disease heterogeneity.

Study Overview

• Status: Completed
• Conditions: Allergic Asthma
• Intervention / Treatment: Drug: Allergen Immunotherapy Extract

Detailed Description

A significant subset of asthma patients exhibits a type 2 inflammatory phenotype characterized by eosinophilic airway inflammation and IgE-mediated immune responses. This phenotype is driven by Th2 cytokines, including IL-4, IL-5, and IL-13, which promote eosinophil recruitment, activation, and survival within the airways. Activated eosinophils release cytotoxic granule proteins such as eosinophil cationic protein (ECP), which contributes to epithelial injury and reflects disease activity. In addition, sputum eosinophil counts are widely validated biomarkers of airway inflammation and are strongly associated with asthma severity and exacerbation risk. Allergen immunotherapy (AIT) is the only disease-modifying treatment for IgE-mediated allergic diseases and represents a cornerstone in the management of allergic asthma. It induces long-term immune tolerance through modulation of allergen-specific immune responses, including suppression of Th2-driven inflammation and enhancement of regulatory immune pathways. Both subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) have demonstrated clinical efficacy in improving asthma outcomes. Recent advances have further elucidated the immunological mechanisms underlying successful AIT, including immune deviation, induction of regulatory T cells, and increased production of blocking antibodies. In addition, personalized medicine approaches increasingly emphasize the role of biomarkers in predicting and monitoring treatment response. Standardization of outcome measures in allergen immunotherapy studies has been strongly recommended to improve comparability across clinical trials and real-world studies. Moreover, real-world evidence continues to support the effectiveness of AIT, although inter-individual variability in response remains a significant clinical challenge. Despite well-established long-term benefits of AIT, early immunologic changes following initiation of SCIT remain insufficiently characterized. Therefore, this study aimed to evaluate early changes in serum eosinophil cationic protein (ECP) and sputum eosinophils following subcutaneous allergen immunotherapy in patients with allergic asthma and to assess their relationship with clinical outcomes.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Mansurah, Egypt, 35516
    • Mohamed AbdElmoniem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age above 18 years and diagnosed of allergic asthma. Patients were clinical stabile and confirmed diagnosis supported by pulmonary function test.

Exclusion Criteria:

• pregnant
• parasitic infestations
• recent acute asthma exacerbation
• current smoking
• severe persistent asthma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Allergic asthma indicated for immunotherapy; Patients above 18 years old and diagnosed with allergic asthma that was partially controlled under standard medical therapy. Patients were selected based on clinical stability and confirmed diagnosis supported by pulmonary function testing.	Drug: Allergen Immunotherapy Extract; Patients diagnosed with allergic asthma that was partially controlled under standard medical therapy indicated for allergen immunotherapy; Other Names: Subcutaneous allergen immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	The change in total asthma symptom score (TASS) following subcutaneous allergen immunotherapy (SCIT) from baseline to 6 months.	6 months

Collaborators and Investigators

• Sponsor: Mansoura University Hospital
• Investigators: Principal Investigator: Mohamed AbdElmoniem, Lecturer of chest medicine faculty of medicine Mansoura university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: July 4, 2026
• First Submitted That Met QC Criteria: July 4, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 4, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Allergen immunotherapy; Eosinophil cationic protein; Subcutaneous immunotherapy
• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Biological Therapy; Immunologic Techniques; Immunomodulation; Immunotherapy; Immunosuppression Therapy; Desensitization, Immunologic
• Other Study ID Numbers: MS.18.11.353.R1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No