Phase 3 Asthma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 12 and 65 years, of any gender, who give written agreement to take part.
• People with a history of moderate to severe hay fever (nose and/or eye symptoms) that comes and goes or is ongoing, caused by grass pollen and cypress-type tree pollen — with or without moderate asthma related to these pollens.
• People whose allergy skin prick test shows a reaction larger than 5 mm to a mixed grass pollen extract or to cypress-type pollen, with the reaction size at least as large as the reaction to histamine (a standard test comparison substance).
• People whose blood test shows a specific allergy antibody level (specific IgE) above 3.5 KU/L for grass pollen (preferably timothy grass) and cypress-type pollen.
• People who own a smartphone, for recording symptoms and medication use during the trial.
• People who are able to follow the dosing schedule required by the trial.
• Women of childbearing age who have a negative urine pregnancy test at the time of joining.
• Women of childbearing potential who commit to using an accepted contraception method during the trial, such as an intrauterine device (fitted at least 3 months before joining), surgical sterilisation, barrier methods, or oral contraceptives.
• People whose skin prick test is negative for other pollens that flower at the same time, and whose IgE for those pollens (if tested) is below 3.5 KU/L with no significant symptoms.
• People whose skin prick test is negative for other common airborne allergens such as dust mites, animal dander, and moulds, and whose IgE for those allergens (if tested) is below 3.5 KU/L with no significant symptoms.

Who may not be able to join:

• People with a positive skin prick test to other airborne allergens, except in cases of occasional exposure to animal dander with only minor symptoms, or sensitivity to pollens that do not overlap in season with cypress or grass.
• People who have received allergy immunotherapy (desensitisation treatment) for any of the relevant allergens within the past 5 years, or who are currently receiving any immunotherapy.
• People for whom allergy immunotherapy is considered absolutely medically inadvisable, based on the criteria of the relevant Spanish and European allergy immunotherapy committees.
• People with severe or poorly controlled asthma, where a breathing test (FEV1) shows lung function below 70% of the expected level despite appropriate medication — or people with severe hay fever symptoms where stopping antihistamine tablets or other systemic antihistamines is medically not advisable.
• People who have previously had a severe reaction during a diagnostic skin prick test.
• People currently taking beta-blocker medications.
• People who are medically unstable at the time of joining, for example those experiencing an asthma flare-up, respiratory infection, fever, or acute hives.
• People with active long-term hives, severe skin writing (dermographism), severe atopic eczema, sunburn, active psoriasis in areas where skin tests would be done, or a history of hereditary angioedema.
• People with a condition where the emergency medication adrenaline (epinephrine) cannot safely be given, such as an overactive thyroid, high blood pressure, or heart disease.
• People with other serious illnesses unrelated to hay fever or asthma that could interfere with treatment or follow-up, such as uncontrolled diabetes, epilepsy, kidney disease, or significant physical abnormalities.
• People with autoimmune diseases (such as thyroid disease or lupus), cancer, or a diagnosed immune deficiency condition.
• People with severe psychiatric conditions or whose health prevents them from cooperating with the trial.
• People with a known allergy to any ingredient in the trial treatment product, other than the allergen being tested.
• People with lung diseases other than asthma, such as emphysema or bronchiectasis.
• People who are close family members of the researchers running the trial.
• Women who are pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.