About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previously performed allergen immunotherapy

Need the use of molecular allergen diagnosis to decide treatment and diagnostic strategy

Trial design

Design model

Parallel

Treatments tested in this trial

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
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.

Treatment groups

210 Participants

are divided into 2 treatment groups

Group A: Standard diagnosisActive comparator 1 intervention

Group B: CRD diagnosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame

0 to 52 weeks

2

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.

Time frame

0 to 24 weeks

3

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.

Time frame

0 to 52 weeks

4

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.

Time frame

0 to 24 weeks

Secondary outcomes

1

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

Time frame

0 to 52 weeks

2

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.

Time frame

0 to 24 weeks

3

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)

Time frame

0 to 52 weeks

4

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)

Time frame

0 to 24 weeks

Molecular Allergen Component Resolved Diagnosis to Decide Immunotherapy

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts