Allergic asthma to house dust mites MedDRA version: 14.1 Level: LLT Classification code 10003558 Term: Asthma extrinsic System Organ Class: 100000004855
Conditions
Interventions
Product Name: Staloral 300 acari
Product Code: Sublingual solution of HDM Allergen Extracts
Pharmaceutical Form: Oral drops
Pharmaceutical form of the placebo: Oral drops
Route of administration of th
Sponsors
ALLEGRIA onlus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Parents’/guardian’s written informed consent, and child’s assent given before any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care; - Age 5 - 3 mm) and/or by ImmunoCAP (specific IgE > 3.5 kU/L) - Clinically stable asthma, with either FEV1>80% predicted or ACT / C-ACT value > 20; - Records’ availability for asthma treatments since one year prior to study entry. Are the trial subjects under 18? yes Number of subjects for this age range: 170 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Actual uncontrolled or severe asthma (FEV1 < 70 %); - History of poor compliance; - History of malignancy (active malignancy, or off therapy since less than one year); - History of autoimmune diseases, immune complex diseases or immune deficiency diseases; - History of infectious diseases (including opportunistic infections) within four weeks prior to study entry; - Cystic fibrosis; - Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis - Any other relevant medical condition representing a contraindication to SIT according to guidelines; - Previous courses of SIT; - History of hypersensitivity to any of the excipients of the study therapy; - Chronic therapy with systemic CS or immunosuppressive drugs and agents; - Ongoing treatment with beta-blockers (including ocular topics); - Use of any investigational drug, device or biologic within 12 months prior to study entry or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At month 24;Main Objective: It is to evaluate the long-term effectiveness either of SLIT or placebo in pediatric allergic asthma, i.e. the sparing effect of asthma-controller medications (either inhaled or oral CS, long-acting bronchodilators, and leukotriene modifiers) and asthma-relievers (rapid-acting bronchodilators) over 24 months.;Secondary Objective: They will be the evaluation of: - Asthma symptoms and signs control (by the patient’s and proxy assessment of the Asthma Control Test-ACT and Childhood-ACT, and by the Allergy Symptom Assessment – i.e. the patient’s & proxy daily diary; - Asthma exacerbation episodes (i.e., implying the use of oral CS); - Changes in asthma medication prescription; - Long-term tolerability and safety profile of SLIT (frequency of adverse events- AEs and serious AEs); - Rhinoconjunctivitis symptoms and signs (using the physician assessed clinical score) and their control through the sparing of rhinoconjunctivitis medications; - SLIT effects on child’s and his/her family’s QoL; - Changes in skin test reactivity patterns at Month 24; - SLIT adherence over 24 months; - The budget impact in the NHS perspective of pediatric allergic asthma resulting from the use of SLIT; -To model cost-effectiveness of SLIT for the treatment of pediatric allergic asthma up to 24 months;Primary end point(s): Effectiveness of either SLIT or placebo added on to asthma SoC therapies for the allergic asthma control improvement will be evaluated by means of the percentage of children with allergic asthma who will have a reduction from baseline of at least 50% in inhaled CS (iCS) doses or a withdrawal of asthma-controller medications (i.e. responders) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At screening visit (one month prior to baseline), at baseline visit, and at month-3,-6,-12,-18 and -24 visits, and at post treatment visitb one month after the IMP interruption.;Secondary end point(s): Other study outcomes and related endpoints will be the longitudinal assessments during 24-month treatment of the following: - The Asthma Control Test (ACT); - Number of asthma exacerbation episodes or asthma attacks by means of the measurement of oral CS use, according to Global Initiative Guidelines in Asthma (GINA); - Changes in asthma SoC treatments; - Frequency of AEs and SAEs; - The Rhinoconjunctivitis Score (Total 5 Symptom Score - T5SS); - Changes in rhinoconjunctivitis medications; - The Allergy Symptom Assessment, i.e. the patient’s & proxy diary; - Child’s and his/her family’s quality of life (QoL), e.g. the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and the Pediatric Asthma Caregivers QoL Questionnaire (PACQLQ); - Changes in skin test reactivity patterns at Month 24 (onset of neosensitizations); - SLIT accountability and adherence over 24 months (defined as > 70% of the study medication taken per treatment course); - The cost of illness (COI) evaluation. | — |
Countries
Italy
Contacts
Public ContactClinical Pharmacology&Trials
IRCCS Istituto G. Gaslini
Outcome results
None listed