Paediatric asthma Respiratory
Conditions
Interventions
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/
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Age
5 Months to 12 Months
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At final year 3 visit: A. *Recurrent wheeze (2 or more wheezing episodes) in the last 12 months of treatment AND B. **Positive SPT and/or sIgE to one or more common allergens during the last 12 months * A wheezing episode is defined as parental or documented report of an episode of wheezing or whistling in the chest that lasts at least 24 hours. Wheezing events separated by at least 5 consecutive days without wheezing shall be counted as separate episodes. **The common allergens include HDM in duplicate (Dermatophagoides pteronyssinus and Dermatophagoides farinae), grass mix, tree mix, cat, dog, cow’s milk, egg, peanut), as assessed both by; 1) SPT =3 mm wheal diameter, OR 2) sIgE =0.35 kU/litre. | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 years post randomisation, in the last 12 months, 1-2 years post randomisation, over 3 years of the study: 1. Allergic Sensitisation and Allergic Disease 1.1 Proportion of participants with ARW assessed at 3 years post-randomisation. Atopy defined as per the primary endpoint and wheeze defined as per the primary endpoint but excluding wheeze episodes occurring only in March to August (inclusive). 1.2 Proportion of participants at 3 years post-randomisation with allergic sensitisation to HDM, as assessed by 1) SPT = 3mm and/or 2) sIgE =0.35 kU/litre and recurrent wheeze during the last 12 months. 2. Allergic Sensitisation 2.1 Cumulative proportion of participants with sensitisation to one or more common allergens over the 3 years of study. The common allergens include HDM (D. pteronyssinus and D. farina), cockroach, grass pollen, tree pollen, ragweed pollen, cat, dog, cow’s milk, egg, peanut), as assessed both by 1) SPT =3 mm and/or 2) sIgE =0.35 kU/litre. 2.2 Cumulative proportion of participants with allergic sensitisation to HDM over the 3 years of study, as assessed by 1) SPT = 3mm and/or 2) sIgE =0.35 kU/litre. 3. Allergic Disease 3.1 Proportion of participants with ARW at 1- and 2-years post-randomisation: (a) Recurrent wheeze: defined as two or more separate wheezing episodes in the last 12 months treatment period. A wheezing episode is defined as parental or documented report of an episode of wheezing or whistling in the chest that lasts at least 24 hours. Wheezing events separated by at least 5 consecutive days without wheezing shall be counted as separate episodes. (b) Atopy: Sensitisation to one or more common allergens in the last 12 months treatment period. The common allergens include HDM (D. pteronyssinus and D. farina), cockroach, grass pollen, tree pollen, ragweed pollen, cat, dog, cow’s milk, egg, peanut), as assessed by SPT =3 mm. 3.2 Proportion of participants with allergic rhinitis in the 12 months before the final study visit | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactRhianne Beveney
Outcome results
None listed