Rhinitis, allergy, house dust mite Respiratory Vasomotor and allergic rhinitis
Conditions
Interventions
Sublingual immunotherapy (SLIT) with house dust mite allergen for 24 - 26 months.
Control: placebo.
Sponsors
Artu Biologicals Europe B.V. (Netherlands)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 6 - 18 years 2. History of allergic rhinitis for at least one year 3. Positive RAST for house dust mite allergy (Y2+) 4. No use of nasal steroids in month before start of baseline measurements 5. Symptom score of at least 4/12 (four nasal symptoms with scores ranging 0 - 3) 6. Informed consent
Exclusion criteria
Exclusion criteria: 1. Severe asthma 2. Allergic sensitivity to pets, in case these are present in the family home 3. Planned surgery of nasal cavity in the course of the study 4. Having received immunotherapy in past three years 5. Contraindications to sublingual immunotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean rhinitis symptom score in September - December after 2 years of SLIT/placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| All in September - December after 2 years of SLIT/placebo, except last outcome below: 1. Proportion of symptom free days 2. Proportion of days without rescue medication 3. Mean eye symptom score 4. Total symptom score 5. Rhinitis specific quality of life questionnaire (PARQLQ) 6. Overall assessment of perceived benefit by child and parent over whole period | — |
Countries
Netherlands
Outcome results
None listed