Clinical trial NCT05448066: Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy
Official title: Molecular Allergen Based Diagnosis Impact on Clinical Efficacy of Aeroallergen Immunotherapy- a Pragmatic Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Rhinitis, Allergic
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Sociedade Portuguesa de Alergologia e Imunologia Clinica
First posted: 2022-07-07
Enrollment: 210
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized controlled trial
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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)
* Patients have indication to AIT to house dust mites and/or grass pollen, association with other allergens is not an exclusion criteria

Exclusion Criteria:

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

Primary outcomes:
measure: Change of combined symptom and medication score (CSMS) at 52 weeks
timeFrame: 0 to 52 weeks
measure: Change of combined symptom and medication score (CSMS) at 24 weeks
timeFrame: 0 to 24 weeks
measure: Change of rhinitis symptoms using visual analogue scale at 52 weeks
timeFrame: 0 to 52 weeks
measure: Change of rhinitis symptoms using visual analogue scale at 24 weeks
timeFrame: 0 to 24 weeks
Secondary outcomes:
measure: Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 52 weeks
timeFrame: 0 to 52 weeks
measure: Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 24 weeks
timeFrame: 0 to 24 weeks
measure: Change in Asthma Control Test (ACT) at 52 weeks
timeFrame: 0 to 52 weeks
measure: Change in Asthma Control Test (ACT) at 24 weeks
timeFrame: 0 to 24 weeks
measure: Change in quality of life related with rhinitis and asthma at 52 weeks
timeFrame: 0 to 52 weeks
measure: Change in quality of life related with rhinitis and asthma at 24 weeks
timeFrame: 0 to 24 weeks
measure: Change in ESPIA score- patient reported opinion allergen immunotherapy at 52 weeks
timeFrame: 0 to 52 weeks
measure: Change in ESPIA score- patient reported opinion allergen immunotherapy at 24 weeks
timeFrame: 0 to 24 weeks
measure: Change in the cost impact between groups
timeFrame: 0 and 52 weeks
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Medicine Porto University/Centro Hospitalar de São João
Study officials:
affiliation: Faculty of Medicine Porto University
name: Diana Silva
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.