Using molecular allergen diagnosis to guide immunotherapy for allergies
Molecular Allergen Based Diagnosis Impact on Clinical Efficacy of Aeroallergen Immunotherapy- a Pragmatic Randomized Clinical Trial
This study tests if using a new type of allergy test can help people with allergic rhinitis and asthma get better results from their allergy treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Universidade do Porto Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Porto) |
| Trial ID | NCT05448066 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of molecular allergen component resolved diagnosis in guiding allergen immunotherapy (AIT) for patients with allergic rhinitis and asthma. It aims to determine if this advanced diagnostic approach can enhance the efficacy of AIT compared to standard diagnostic methods. Participants will include individuals over five years old who are sensitized to specific allergens and have a medical indication for AIT. The study will be conducted in a real-life setting to assess the practical implications of this diagnostic strategy.
Who should consider this trial
Good fit: Ideal candidates include individuals over five years old with a medical indication for AIT due to allergic rhinitis or asthma and evidence of IgE sensitization.
Not a fit: Patients who have previously undergone allergen immunotherapy or do not require molecular allergen diagnosis for treatment decisions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients suffering from allergic diseases.
How similar studies have performed: While the use of molecular allergen diagnosis is an evolving field, there is ongoing research, but this specific approach's efficacy in AIT remains to be fully established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Porto
- Faculty of Medicine Porto University/Centro Hospitalar de São João — Porto, Portugal (Recruiting)
Study contacts
- Principal investigator: Diana Silva — Faculty of Medicine Porto University
- Study coordinator: Diana M Silva, PhD
- Email: dianapereirasilva@chsj.min-saude.pt
- Phone: 964021365
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.