- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07694947
Changes in Eosinophil Cationic Protein and Sputum Eosinophils Following Allergen Immunotherapy
4. juli 2026 opdateret af: Mohamed Abd Elmoniem Mohamed, Mansoura University Hospital
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Al Mansurah, Egypten, 35516
- Mohamed AbdElmoniem
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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Patients diagnosed with allergic asthma that was partially controlled under standard medical therapy indicated for allergen immunotherapy
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical response
Tidsramme: 6 months
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The change in total asthma symptom score (TASS) following subcutaneous allergen immunotherapy (SCIT) from baseline to 6 months.
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Mohamed AbdElmoniem, Lecturer of chest medicine faculty of medicine Mansoura university
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2023
Primær færdiggørelse (Faktiske)
1. juli 2023
Studieafslutning (Faktiske)
1. januar 2024
Datoer for studieregistrering
Først indsendt
4. juli 2026
Først indsendt, der opfyldte QC-kriterier
4. juli 2026
Først opslået (Faktiske)
10. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MS.18.11.353.R1
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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