Allergic Rhinitis Due to House Dust Mite
Conditions
Keywords
House Dust Mite Allergic Rhinitis, Phase I, House Dust Mite Allergen Extract
Brief 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.
Interventions
One sublingual tablet daily during 10 days
BIOLOGICAL1000 IR house dust mites allergen extract tablet
Two sublingual tablets daily during 10 days
BIOLOGICAL1500 IR house dust mites allergen extract tablet
Three sublingual tablets daily during 10 days
BIOLOGICALPlacebo tablet
One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
Sponsors
Stallergenes Greer
Syneos Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Evaluated on Treatment Emergent Adverse Events | 10 dosing treatment days | Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Serious Adverse Events | 10 dosing treatment days | Treatment emergent Serious Adverse Events |
| Adverse Events Leading to Study Withdrawal | 10 dosing treatment days | Incidence of adverse events leading to study withdrawal |
Countries
Canada
Participant flow
Recruitment details
First Patient First Visit 29 JUL 2013, Last Patient Last Visit 30 SEP 2013
Participants by arm
| Arm | Count |
|---|---|
| 500 IR 500 IR house dust mites allergen extract tablet
500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days | 9 |
| 1000 IR 1000 IR house dust mites allergen extract tablet
1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days | 9 |
| 1500 IR 1500 IR house dust mites allergen extract tablet
1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days | 9 |
| Placebo Placebo tablet
Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets | 10 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | 500 IR | 1000 IR | 1500 IR | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 15.4 years STANDARD_DEVIATION 1.33 | 14.1 years STANDARD_DEVIATION 1.45 | 15.3 years STANDARD_DEVIATION 1.12 | 14.6 years STANDARD_DEVIATION 1.78 | 14.9 years STANDARD_DEVIATION 1.49 |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 5 Participants | 7 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 4 Participants | 3 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 9 | 6 / 9 | 9 / 9 | 4 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 10 |
Outcome results
Primary
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events
Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)
Time frame: 10 dosing treatment days
Population: Safety Set: All patients who received at least one dose of treatment including those who did not complete the study were included in the Safety Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500 IR | Safety and Tolerability Evaluated on Treatment Emergent Adverse Events | 4 participants |
| 1000 IR | Safety and Tolerability Evaluated on Treatment Emergent Adverse Events | 6 participants |
| 1500 IR | Safety and Tolerability Evaluated on Treatment Emergent Adverse Events | 9 participants |
| Placebo | Safety and Tolerability Evaluated on Treatment Emergent Adverse Events | 4 participants |
Secondary
Adverse Events Leading to Study Withdrawal
Incidence of adverse events leading to study withdrawal
Time frame: 10 dosing treatment days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500 IR | Adverse Events Leading to Study Withdrawal | 0 participants |
| 1000 IR | Adverse Events Leading to Study Withdrawal | 0 participants |
| 1500 IR | Adverse Events Leading to Study Withdrawal | 0 participants |
| Placebo | Adverse Events Leading to Study Withdrawal | 0 participants |
Secondary
Treatment Emergent Serious Adverse Events
Treatment emergent Serious Adverse Events
Time frame: 10 dosing treatment days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 500 IR | Treatment Emergent Serious Adverse Events | 0 participants |
| 1000 IR | Treatment Emergent Serious Adverse Events | 0 participants |
| 1500 IR | Treatment Emergent Serious Adverse Events | 0 participants |
| Placebo | Treatment Emergent Serious Adverse Events | 0 participants |