Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy

NCT05448066 | Recruiting

• 1 other identifier: 2017-21
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Allergen immunotherapy (AIT) is used for the control of allergic diseases that are not completely responsive to avoidance strategies and/or pharmacotherapy. It is also considered the main treatment with the potential to modify allergic disease evolution. It's efficacy and safety in allergic rhinitis and asthma is supported by large systematic reviews and is recommended as a cornerstone treatment option in allergic disease. Molecular based allergy diagnosis has greatly evolved and the knowledge of molecular allergen sensitization pattern has been used to better define the allergen extract composition of AIT. However, uncertainty remains if this strategy is related to an increase of efficacy. Regulation of allergen extracts for allergen immunotherapy are currently underway in Europe, but there is still lack of standardization of relevant allergens and important differences are seen between allergenic contents. Therefore, we aim to evaluate, in a real-life setting, the impact of using molecular-based diagnosis versus standard diagnostic tools in the efficacy of aeroallergen immunotherapy, using a pragmatic randomized controlled trial design and also to address the impact of the discrepancy between individual aeroallergen sensitization profiles and the major allergen molecular content of aeroallergen immunotherapy.

Conditions

Asthma; Rhinitis, Allergic

Outcome Measures

Primary Outcomes (4)

• Change of combined symptom and medication score (CSMS) at 52 weeks

  Differences, in the mean change at 52 weeks, of CSMS between groups that were treated with AIT in the component resolved diagnosis versus standard diagnosis groups. CSMS is the sum of the daily symptom score (dSS, score 0 to 3) plus daily medication score (dMS; score 0 to 6)

  0 to 52 weeks

• Change of combined symptom and medication score (CSMS) at 24 weeks

  Difference, in the mean change at 24 weeks, of CSMS between groups were treated with AIT in the component resolved diagnosis versus standard diagnosis groups.

  0 to 24 weeks

• Change of rhinitis symptoms using visual analogue scale at 52 weeks

  Difference between groups(control vs intervention) in the mean change at 52 weeks, in the psychometric response scale. This scale is used to assess rhinoconjunctivitis discomfort and its impacts on symptom severity and need of treatment.

  0 to 52 weeks

• Change of rhinitis symptoms using visual analogue scale at 24 weeks

  Difference between groups(control vs intervention) in the mean change at 52 weeks, in the psychometric response scale. This scale is used to assess rhinoconjunctivitis discomfort and its impacts on symptom severity and need of treatment.

  0 to 24 weeks

Secondary Outcomes (9)

• Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 52 weeks

  0 to 52 weeks

• Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 24 weeks

  0 to 24 weeks

• Change in Asthma Control Test (ACT) at 52 weeks

  0 to 52 weeks

• Change in Asthma Control Test (ACT) at 24 weeks

  0 to 24 weeks

• Change in quality of life related with rhinitis and asthma at 52 weeks

  0 to 52 weeks

Study Arms (2)

Standard diagnosis

ACTIVE COMPARATOR

Patients followed in the allergy clinic with indication for allergen immunotherapy using only standard diagnosis.

Diagnostic Test: Standard diagnosis

CRD diagnosis

EXPERIMENTAL

Patients followed in the allergy clinic with indication for allergen immunotherapy decided with standard diagnostic tools and molecular based diagnosis.

Diagnostic Test: Component resolved diagnosis

Interventions

Component resolved diagnosis DIAGNOSTIC_TEST

Physicians in this group will have access to allergen molecular component sensitization profile, using ImmunoCAP ISAC E112i and to all standard diagnostic tolls

CRD diagnosis

Standard diagnosis DIAGNOSTIC_TEST

Physicians will only have access to standard diagnostic tools namely skin prick tests and sIgE sensitization (not molecular IgE) and clinical history.

Standard diagnosis

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with medical indication for aeroallergen immunotherapy(AIT) for allergic rhinoconjunctivitis or asthma, accordingly to the AIT guidelines;
• Over 5 years of age;
• Evidence of IgE-sensitization (positive skin prick tests and / or serum specific-IgE)

You may not qualify if:

• Previously performed allergen immunotherapy
• Need the use of molecular allergen diagnosis to decide treatment and diagnostic strategy

Sponsors & Collaborators

• Universidade do Porto: lead
• Sociedade Portuguesa de Alergologia e Imunologia Clinica: collaborator

Study Sites (1)

Faculty of Medicine Porto University/Centro Hospitalar de São João

Porto, Portugal

RECRUITING

Related Publications (3)

• Roberts G, Pfaar O, Akdis CA, Ansotegui IJ, Durham SR, Gerth van Wijk R, Halken S, Larenas-Linnemann D, Pawankar R, Pitsios C, Sheikh A, Worm M, Arasi S, Calderon MA, Cingi C, Dhami S, Fauquert JL, Hamelmann E, Hellings P, Jacobsen L, Knol EF, Lin SY, Maggina P, Mosges R, Oude Elberink JNG, Pajno GB, Pastorello EA, Penagos M, Rotiroti G, Schmidt-Weber CB, Timmermans F, Tsilochristou O, Varga EM, Wilkinson JN, Williams A, Zhang L, Agache I, Angier E, Fernandez-Rivas M, Jutel M, Lau S, van Ree R, Ryan D, Sturm GJ, Muraro A. EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis. Allergy. 2018 Apr;73(4):765-798. doi: 10.1111/all.13317. Epub 2017 Oct 30.

  PMID: 28940458 BACKGROUND

• Matricardi PM, Dramburg S, Potapova E, Skevaki C, Renz H. Molecular diagnosis for allergen immunotherapy. J Allergy Clin Immunol. 2019 Mar;143(3):831-843. doi: 10.1016/j.jaci.2018.12.1021.

  PMID: 30850070 BACKGROUND

• Dhami S, Nurmatov U, Arasi S, Khan T, Asaria M, Zaman H, Agarwal A, Netuveli G, Roberts G, Pfaar O, Muraro A, Ansotegui IJ, Calderon M, Cingi C, Durham S, van Wijk RG, Halken S, Hamelmann E, Hellings P, Jacobsen L, Knol E, Larenas-Linnemann D, Lin S, Maggina P, Mosges R, Oude Elberink H, Pajno G, Panwankar R, Pastorello E, Penagos M, Pitsios C, Rotiroti G, Timmermans F, Tsilochristou O, Varga EM, Schmidt-Weber C, Wilkinson J, Williams A, Worm M, Zhang L, Sheikh A. Allergen immunotherapy for allergic rhinoconjunctivitis: A systematic review and meta-analysis. Allergy. 2017 Nov;72(11):1597-1631. doi: 10.1111/all.13201. Epub 2017 Jul 14.

  PMID: 28493631 BACKGROUND

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Study Officials

• Diana Silva

  Faculty of Medicine Porto University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana M Silva, PhD

CONTACT

964021365; dianapereirasilva@chsj.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic randomized controlled trial

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: July 7, 2022
• Study Start: July 30, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 6, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)