AsthmaCRD-AITNCT05448066
Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy
A study testing Component resolved diagnosis and Standard diagnosis in people with Asthma and Rhinitis, Allergic, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Asthma, Rhinitis, Allergic
- What is being tested?
- Component resolved diagnosis and Standard diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Jul 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previously performed allergen immunotherapy
- Need the use of molecular allergen diagnosis to decide treatment and diagnostic strategy
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Medicine Porto University/Centro Hospitalar de São João
Porto
Diana Silva, PhD, 964021365
Diana Silva, PhD
About this study
Official title: Molecular Allergen Based Diagnosis Impact on Clinical Efficacy of Aeroallergen Immunotherapy- a Pragmatic Randomized Clinical Trial
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
- Being tested
- Component resolved diagnosis, Standard diagnosis
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Component resolved diagnosisDiagnostic test
Physicians in this group will have access to allergen molecular component sensitization profile, using ImmunoCAP ISAC E112i and to all standard diagnostic tolls
Standard diagnosisDiagnostic test
Physicians will only have access to standard diagnostic tools namely skin prick tests and sIgE sensitization (not molecular IgE) and clinical history.
| Study group | Role | What they receive |
|---|---|---|
| Standard diagnosis | Active comparator | Patients followed in the allergy clinic with indication for allergen immunotherapy using only standard diagnosis. Receives: 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. Receives: Diagnostic Test: Component resolved diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 to 24 weeks
Secondary outcomes (9)
Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 52 weeks
Differences between groups (control vs intervention) in the mean change at 52 weeks in the scores obtained on the self-administered Portuguese validated questionnaire that assess symptoms and control of both allergic rhinitis and asthma in the previous 4 weeks. The final score ranges from 0 to 30, with scores over 24 indicating good control of asthma and allergic rhinitis, a four-point changes will be considered the minimal important difference
Measured: 0 to 52 weeks
Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 24 weeks
Differences between groups (control vs intervention) in the mean change at 24 weeks in the scores obtained on the self-administered Portuguese validated questionnaire that assess symptoms and control of both allergic rhinitis and asthma in the previous 4 weeks. The final score ranges from 0 to 30, with scores over 24 indicating good control of asthma and allergic rhinitis, a four-point changes will be considered the minimal important difference.
Measured: 0 to 24 weeks
Change in Asthma Control Test (ACT) at 52 weeks
Differences between control and intervention group of change in the self-report questionnaire regarding asthma symtoms that includes 5 items assessing each of the following for the previous 4 weeks. ACT score ranges from 5 (poor control of asthma) to 25 (complete control of asthma)
Measured: 0 to 52 weeks
Change in Asthma Control Test (ACT) at 24 weeks
Differences between control and intervention group of change in the self-report questionnaire regarding asthma symtoms that includes 5 items assessing each of the following for the previous 4 weeks. ACT score ranges from 5 (poor control of asthma) to 25 (complete control of asthma)
Measured: 0 to 24 weeks
Change in quality of life related with rhinitis and asthma at 52 weeks
Difference between groups regarding self-administered version of Rhinoconjunctivitis Quality of Life Questionnaire which is validated in Portuguese for patients over 12 years at 52 weeks. A change greater than 0.5 will be considered a critically clinically significant difference
Measured: 0 to 52 weeks
Change in quality of life related with rhinitis and asthma at 24 weeks
Differences between groups regarding the self-administered version of Rhinoconjunctivitis Quality of Life Questionnaire which is validated in Portuguese for patients over 12 years at 24 weeks. A change greater than 0.5 will be considered a critically clinically significant difference
Measured: 0 to 24 weeks
Change in ESPIA score- patient reported opinion allergen immunotherapy at 52 weeks
Differences between intervention and control groups in the self-administered questionnaire with 16 questions distributed in 4 dimensions: perception of effectiveness, activities and environment, cost-benefit balance and general satisfaction at 52 weeks
Measured: 0 to 52 weeks
Change in ESPIA score- patient reported opinion allergen immunotherapy at 24 weeks
Differences in the self-administered questionnaire with 16 questions distributed in 4 dimensions: perception of effectiveness, activities and environment, cost-benefit balance and general satisfaction at 24 weeks
Measured: 0 to 24 weeks
Change in the cost impact between groups
Direct and indirect healthcare related costs will be assessed in each of the groups before and after treatment and compared
Measured: 0 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start30 Jul 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedade Portuguesa de Alergologia e Imunologia Clinica
- Responsible party
- Sponsor
- Investigators
- Diana Silva, Principal investigator, Faculty of Medicine Porto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448066
- Sponsor's protocol ID
- 2017-21
- Acronym
- CRD-AIT
- Status last verified
- Jun 2024
- First submitted
- 21 Apr 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data
Publications
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.
PubMed 28940458Matricardi 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.
PubMed 30850070Dhami 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.
PubMed 28493631
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Allergen Based Diagnosis Impact on Clinical Efficacy of Aeroallergen Immunotherapy- a Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05448066
- Acronym / sponsor ID
- CRD-AIT / 2017-21
- Conditions
- Asthma, Rhinitis, Allergic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Sociedade Portuguesa de Alergologia e Imunologia Clinica
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard diagnosis | Active comparator | Diagnostic Test: Standard diagnosisPatients followed in the allergy clinic with indication for allergen immunotherapy using only standard diagnosis. |
| CRD diagnosis | Experimental | Diagnostic Test: Component resolved diagnosisPatients followed in the allergy clinic with indication for allergen immunotherapy decided with standard diagnostic tools and molecular based diagnosis. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Previously performed allergen immunotherapy
- Need the use of molecular allergen diagnosis to decide treatment and diagnostic strategy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Component resolved diagnosisPhysicians in this group will have access to allergen molecular component sensitization profile, using ImmunoCAP ISAC E112i and to all standard diagnostic tolls | Diagnostic test | CRD diagnosis |
| Standard diagnosisPhysicians will only have access to standard diagnostic tools namely skin prick tests and sIgE sensitization (not molecular IgE) and clinical history. | Diagnostic test | Standard diagnosis |
Primary outcome
Change of combined symptom and medication score (CSMS) at 52 weeks
Time frame: 0 to 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)
Change of combined symptom and medication score (CSMS) at 24 weeks
Time frame: 0 to 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.
Change of rhinitis symptoms using visual analogue scale at 52 weeks
Time frame: 0 to 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.
Change of rhinitis symptoms using visual analogue scale at 24 weeks
Time frame: 0 to 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.
9 secondary outcomes
Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 52 weeks
Time frame: 0 to 52 weeks
Change in Control of Allergic Rhinitis and Asthma Test (CARAT) at 24 weeks
Time frame: 0 to 24 weeks
Change in Asthma Control Test (ACT) at 52 weeks
Time frame: 0 to 52 weeks
Change in Asthma Control Test (ACT) at 24 weeks
Time frame: 0 to 24 weeks
Change in quality of life related with rhinitis and asthma at 52 weeks
Time frame: 0 to 52 weeks
Change in quality of life related with rhinitis and asthma at 24 weeks
Time frame: 0 to 24 weeks
Change in ESPIA score- patient reported opinion allergen immunotherapy at 52 weeks
Time frame: 0 to 52 weeks
Change in ESPIA score- patient reported opinion allergen immunotherapy at 24 weeks
Time frame: 0 to 24 weeks
Change in the cost impact between groups
Time frame: 0 and 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 28940458Roberts 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.
- Background: PubMed 30850070Matricardi 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.
- Background: PubMed 28493631Dhami 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.
- Individual participant dataSharing planned: No. All data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Silva principal investigator
Faculty of Medicine Porto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Component resolved diagnosis and Standard diagnosis in people with Asthma and Rhinitis, Allergic, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana M Silva, PhD (964021365, dianapereirasilva@chsj.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of combined symptom and medication score (CSMS) at 52 weeks (time frame: 0 to 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05448066, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.