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New treatment option for Allergic Reaction
Official title Quercus Ilex and Quercus Robur Allergen Extracts Standardisation
ClinicalTrials.gov ID: NCT05532566
What this study is testing
- What it's testing
- The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- people must live in a geographical area where allergic problems caused by Quercus ilex and Quercus robur are relevant.
- Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Quercus ilex and Quercus robur.
- A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.
- The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2.
- Age: Between 18 and 64 years old.
You likely can't join if
- people should not be excluded in terms of low or high sensitivity to Quercus ilex and Quercus robur.
- people outside the age range.
- people who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma...
- people with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is...
- people who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.
- people under treatment with ß-blockers.
See the full eligibility criteria
- people must live in a geographical area where allergic problems caused by Quercus ilex and Quercus robur are relevant.
- Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Quercus ilex and Quercus robur.
- A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.
- The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2.
- Age: Between 18 and 64 years old.
- people must be able to give informed consent.
- people should not be excluded in terms of low or high sensitivity to Quercus ilex and Quercus robur.
- people outside the age range.
- people who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may...
- people with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
- people who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.
- people under treatment with ß-blockers.
- people clinically unstable (acute asthma, febrile, etc.).
- people with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).
- people with active viral infection by herpes simplex or herpes varicella zoster in the area where the prick test is performed.
- people with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.).
- States of the subject in which he/she cannot offer cooperation and severe psychiatric disorders.
- Pregnant women or women at risk of pregnancy and lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.