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OpenTrials
Completed

NCT Number: NCT07694947

Changes in Eosinophil Cationic Protein and Sputum Eosinophils Following Allergen Immunotherapy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Allergen Immunotherapy Extract

Drug

Patients diagnosed with allergic asthma that was partially controlled under standard medical therapy indicated for allergen immunotherapy

Other names: Subcutaneous allergen immunotherapy

Primary outcomes

  1. Clinical response

    Time frame: 6 months

    The change in total asthma symptom score (TASS) following subcutaneous allergen immunotherapy (SCIT) from baseline to 6 months.

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

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.

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