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 who have signed and dated a consent form agreeing to take part in the trial.
• People aged 12 to 65 years old at the time of signing the consent form (both ages included).
• People who have had a confirmed history of allergy to something inhaled — specifically house dust mites (Dermatophagoides pteronyssinus and/or Dermatophagoides farinae) — causing moderate to severe hay fever-like symptoms (nose and/or eye symptoms) for at least one year, with or without mild to moderate controlled asthma.
• People who have had a positive skin prick allergy test showing a reaction of at least 5 mm to a standardised house dust mite allergen extract.
• Women who could become pregnant must have a negative blood pregnancy test and a confirmed menstrual period before joining the study.
• Women who could become pregnant must commit to using an effective contraception method during the trial and for one month after the treatment ends (confirm with trial site for the full list of accepted methods).
• People who are able and willing to follow the treatment schedule as required by the trial.
• People who own a smartphone, as it will be used to record symptoms and medication use.
• People who are either not allergic to any other clinically significant allergen, or whose additional allergies meet specific conditions — for example, those with animal dander allergy who only have occasional exposure and symptoms, or those with pollen allergy who can be scheduled so that the pollen season does not overlap with key study periods (confirm with trial site for full details; grass pollen-sensitive participants in Latin America are not included).
• People who test negative for allergies to moulds, cockroach, Blomia tropicalis, or other geographically relevant mites (based on skin prick test or specific blood test results below a set level).
• People whose nose and eye symptom scores during a baseline monitoring period reach a moderate-to-severe level on at least 10 days during that period.
• People whose blood test shows a specific immune response (IgE level) to house dust mite allergen at or above a set threshold.

Who may not be able to join:

• People who have received allergy immunotherapy for any of the tested allergens in the past 5 years, or any desensitisation treatment (such as oral immunotherapy for food allergy) in the past 2 years, or who are currently receiving immunotherapy for any allergen.
• People for whom allergen immunotherapy would be medically contraindicated according to established European allergy guidelines (confirm with trial site).
• People with asthma whose lung function test result (FEV1) is below 80% of the expected value at the time of enrolment, even after appropriate medication.
• People with uncontrolled asthma — for example, those with frequent symptoms, frequent need for reliever medication, asthma that limits daily activities, night-time waking due to asthma, two or more asthma attacks per year needing steroid tablets, or at least one hospitalisation per year due to asthma.
• People with severe asthma requiring the highest levels of treatment (Steps 4 or 5 under GINA 2022 guidelines) and who still have poor symptom control despite correct use of medication.
• People currently taking beta-blocker medications or ACE inhibitor medications.
• People currently taking immunosuppressant or biological medications.
• People who have not completed a required period of stopping certain medications before allergy testing at the first screening visit (confirm with trial site for specific medication washout periods).
• People who have had a respiratory tract infection or asthma flare-up within the 4 weeks before the first screening visit.
• People who have experienced chronic hives (urticaria), severe anaphylaxis, or hereditary angioedema within the 2 years before the first screening visit.
• People who have a medical condition that means adrenaline (epinephrine) — used in emergencies — could not safely be given to them, such as an overactive thyroid, heart disease, or high blood pressure.
• People with other serious illnesses unrelated to allergic rhinitis or asthma that could interfere with the study treatment or monitoring.
• People with severe autoimmune diseases that have not responded to treatment (such as certain thyroid conditions or lupus), active cancer, or immune system deficiencies.
• People who the trial investigator believes would not be able to follow the study requirements, or who have a serious mental health condition.
• People who are known to be allergic to any ingredient in the study treatment other than the study allergens themselves.
• People with nasal conditions — such as nasal polyps, a significantly deviated nasal septum, or non-allergic rhinitis — that could affect how the trial results are assessed.
• People who have had nasal surgery within the 6 months before the first screening visit, or who have planned nasal surgery scheduled during the trial.
• People who have a sore or lesion inside the mouth that could affect the safety assessment of the study treatment.
• People who need antihistamines or corticosteroids for reasons other than managing allergic nose or eye symptoms (except short-term use for conditions like a common cold).
• People with lung diseases other than asthma, such as emphysema, bronchiectasis, or chronic obstructive pulmonary disease (COPD).
• Women who are pregnant or breastfeeding.
• People who are immediate family members of anyone running the trial.
• People currently participating in another clinical trial, or who have participated in one within 30 days before the first screening visit.
• People with a history of serious allergic reactions to foods, insect stings, medications, or other substances.
• People who are expected to have significant changes in their living circumstances during the study (for example, moving home).
• People who plan to start using anti-mite bedding covers or similar products during the study.
• People the trial investigator considers unsuitable for the study for any other reason.

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