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 have given written consent to participate.
• People with a confirmed history of allergic rhinitis (hay fever-type nasal symptoms, either occasional or ongoing, at a moderate-to-severe level) and/or eye symptoms caused by an allergy to house dust mites (Dermatophagoides pteronyssinus and/or Dermatophagoides farinae), with or without mild-to-moderate controlled asthma.
• People whose asthma diagnosis was made at least 12 months before signing the consent form.
• People who have had a positive skin prick test result (a wheal larger than 5 mm) to house dust mites, with the test result being valid within 12 months before signing the consent form.
• People with a blood test result showing a specific allergic antibody (IgE) level greater than 3.5 KU/mL to house dust mite allergens.
• People who are primarily allergic only to the study mites, or who may also have other airborne allergies under specific conditions — for example, allergies to certain other mites (with IgE no higher than 3.5 KU/L), animal fur/dander with only occasional exposure and symptoms, or pollen (with IgE no higher than 17.5 KU/L and no symptom flare-ups during pollen season).
• People with a negative skin test result for mould/fungi allergies.
• Women who could become pregnant must have a negative urine pregnancy test before the first dose of the trial treatment.
• Women who could become pregnant and are sexually active must agree to use an appropriate method of contraception for the duration of the trial.
• People who are able to follow the dosing schedule as required.
• People who own a smartphone, as this is needed for recording symptoms during the trial.

Who may not be able to join:

• People who have received allergy immunotherapy (for animal dander, fungi, or mites) within the past 5 years.
• People for whom allergy immunotherapy is considered absolutely contraindicated according to established allergy society guidelines (confirm with trial site).
• People with severe or uncontrolled asthma, or whose lung function (measured by a breathing test called FEV1) is below 70% of the expected level despite appropriate medication.
• People with severe nasal or eye allergy symptoms for whom antihistamine tablets or other oral treatments are not medically appropriate.
• People who have previously had a serious reaction during an allergy skin prick test.
• People currently taking a type of heart or blood pressure medication called beta-blockers.
• People who are medically unstable at the time of joining, such as those experiencing an asthma flare-up, a respiratory infection, fever, or acute hives.
• People with ongoing chronic 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 (a condition causing sudden swelling).
• People with other serious medical conditions unrelated to their allergy symptoms that could interfere with the trial, such as uncontrolled epilepsy, uncontrolled diabetes, kidney disease, or significant physical malformations.
• People with autoimmune diseases (such as thyroid disease or lupus), cancer, or diagnosed immune system deficiencies.
• People whose condition prevents them from cooperating with the trial, or who have a serious mental illness.
• People with a known allergy to any ingredient in the trial treatment other than the mite allergen itself.
• People with lung diseases other than asthma, such as emphysema or bronchiectasis.
• Close relatives of the investigators running the trial.
• Women who are pregnant or currently breastfeeding.

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