Preventing childhood Asthma using Prophylactic house dust mite Allergen immunotherapy
Paediatric asthma
Active intervention: Acarizax (12 SQ-HDM SLIT). Control: Placebo. Dose: 30 µg. Dose frequency: Once daily. Route of administration: Sublingual. All infants will be reviewed every 6 weeks by telephone/video call, in the first year and then every 3 months. The researchers will be contactable 24 hours a day and if there are any concerns, they will arrange an in-person visit to the hospital clinic. Each year, children will also be seen in clinic to complete a questionnaire and have allergy tests. A breathing test will be done at the last visit. A sample of blood will be collected when each child is recruited at the beginning of the study and at their last visit. Randomisation method: minimisation through Sealed Envelope.
1. Parent/guardian must be able to understand and provide informed consent. 2. Aged 5 to 12 months of age at randomisation. 3. High risk of asthma (two or more of the three criteria): a. Single OR dual heredity for allergy (at least one biological mother, father or sibling affected by asthma or allergy, assessed through standardised questionnaires). b. Atopic dermatitis. c. Allergen sensitisation.
1. Evidence of sensitisation to HDM on skin prick test (SPT) ≥3 mm wheal diameter OR sIgE ≥ 0.35 kU/L 2. Prematurity (<37 weeks) 3. Faltering growth and/or need for oxygen for more than 5 days in the neonatal period or history of intubation or mechanical ventilation 4. Other significant medical conditions including but not limited to eosinophilic esophagitis, seizures, major congenital anomalies, cardiac disorders requiring medical therapy, cystic fibrosis, chronic pulmonary diseases, bronchopulmonary dysplasia, significant developmental delay, cerebral palsy, immunodeficiency (primary or secondary) 5. Use of investigational drugs since birth 6. Expecting to relocate out of country within 4 years of study initiation 7. Deemed as unable to adhere to study activities by the investigator 8. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant’s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study 9. Has any clinically significant abnormal vital sign or laboratory value that in the opinion of the investigator would preclude participation in the trial