Phase 1
N=37
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents
Allergic Rhinitis Due to House Dust Mite
Bottom Line
View on ClinicalTrials.gov: NCT01919554 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Safety and Tolerability Evaluated on Treatment Emergent Adverse Events — 4; 6; 9; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 500 IR house dust mites allergen extract tablet (Biological); 1000 IR house dust mites allergen extract tablet (Biological); 1500 IR house dust mites allergen extract tablet (Biological); Placebo tablet (Biological)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Stallergenes Greer
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability Evaluated on Treatment Emergent Adverse Events |
4; 6; 9; 4 | — |
| SECONDARY Treatment Emergent Serious Adverse Events |
0; 0; 0; 0 | — |
| SECONDARY Adverse Events Leading to Study Withdrawal |
0; 0; 0; 0 | — |
Summary
The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.
Eligibility Criteria
Inclusion Criteria
- Written informed consent from patient and parent(s)/legal representative.
- Male or female patient from 12 to 17 years.
- Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
- Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
- Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
- Spirometry with best FEV1 > 80% of predicted FEV1.
Exclusion Criteria
- Patient with a nasal or oral disease that could interfere with the safety assessments
- Patient has undergone recent nasal surgery
- Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5.
- Patient with partially controlled or uncontrolled asthma
- Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
- Female patient pregnant or breast-feeding/lactating.
- Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method.
- Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
- Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen.
- patient with a history of anaphylaxis
- patient having participated in any clinical study within the 12 weeks before visit 1
Data sourced from ClinicalTrials.gov (NCT01919554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.