Phase 3 Asthma Trial, Recruiting

Written by an AI model from the 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 who have signed the informed consent form for the trial.
• People aged between 12 and 65 years (any sex).
• People with a confirmed history of nasal or eye allergy symptoms (such as hay fever or allergic eye inflammation, ranging from moderate to severe) caused by grass pollen and olive pollen, with or without mild-to-moderate asthma that is currently under control — the asthma diagnosis must have been made at least 12 months before joining.
• People who have had a positive skin prick test (a common allergy skin test) to grass pollen extracts or olive pollen extract, showing a raised bump of 5mm or more.
• People whose blood allergy test (specific IgE) shows a level greater than 3.5 KU/L for grass pollen (preferably timothy grass) or olive pollen, or related allergy components.
• Women who could become pregnant must have a negative urine pregnancy test at the time of joining.
• Women who could become pregnant, and men taking part, must agree to use an accepted form of contraception — such as an intrauterine device placed at least 3 months before joining, surgical sterilisation, barrier methods, or oral contraceptives.
• People who are able to follow the treatment schedule as required.
• People who own a smartphone, which will be used to record symptoms and medication use.
• People whose skin prick test to other seasonal pollens (that overlap with the trial period) is negative — and if a blood allergy test is available, the result should be below 3.5 KU/L with no noticeable symptoms from those pollens.
• People whose skin prick test to other common airborne allergens (such as dust mites, animal dander, and moulds) is negative — and if a blood allergy test is available, the result should be below 3.5 KU/L with no noticeable symptoms from those allergens.

Who may not be able to join:

• People who are allergic to multiple airborne allergens beyond grass and olive pollen (exceptions may apply for animal dander with only occasional exposure and mild symptoms — confirm with trial site).
• People who are sensitive to other airborne allergens beyond grass and olive pollen, including non-seasonal pollens (confirm with trial site).
• People who have received allergy immunotherapy (desensitisation treatment) for any airborne allergen within the past 5 years.
• People for whom immunotherapy is considered absolutely contraindicated according to the guidelines of the relevant Spanish and European allergy and immunology committees (confirm with trial site).
• People with severe or uncontrolled persistent asthma, or whose lung function (a breathing measurement called FEV1) is below 70% of the expected level even with appropriate medication — or people whose nasal or eye allergy symptoms are so severe that stopping antihistamine treatment would be medically unsafe.
• People who have previously had a serious reaction during a skin prick test.
• People currently taking beta-blocker medications.
• People who are medically unstable at the time of joining — for example, those currently experiencing an asthma flare-up, a breathing infection, a fever, or a sudden episode of hives.
• People with ongoing chronic hives, severe skin writing (dermographism), severe atopic dermatitis (eczema), sunburn, active psoriasis in areas where skin tests would be done, or a history of hereditary angioedema (a condition causing sudden swelling).
• People who have a condition that means adrenaline (epinephrine) cannot safely be given to them — such as an overactive thyroid, uncontrolled high blood pressure, or heart disease.
• People with another serious medical condition unrelated to their nasal or breathing allergy that could interfere with the trial — such as uncontrolled diabetes, epilepsy, kidney disease, or certain other significant health conditions.
• People with autoimmune diseases (such as thyroid disease or lupus), cancer, or a diagnosed immune system deficiency.
• People with severe psychiatric disorders that would prevent them from cooperating with the trial.
• People with a known allergy to any ingredient in the trial medication (other than the allergen being studied).
• People with lung diseases other than asthma — such as emphysema or bronchiectasis.
• People who are close relatives of the researchers running the trial.
• People who are pregnant or currently breastfeeding.

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