Sublingual immunotherapy with house dust mite allergen in children with allergic rhinitis: randomised double-blind placebo-controlled trial
- Conditions
- Rhinitis, allergy, house dust miteRespiratoryVasomotor and allergic rhinitis
- Registration Number
- ISRCTN91141483
- Lead Sponsor
- Artu Biologicals Europe B.V. (Netherlands)
- Brief Summary
2008 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/18937864 protocol 2012 Results article in https://pubmed.ncbi.nlm.nih.gov/22017365/ (added 27/10/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 251
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean rhinitis symptom score in September - December after 2 years of SLIT/placebo.
- Secondary Outcome Measures
Name Time Method <br> All in September - December after 2 years of SLIT/placebo, except last outcome below:<br> 1. Proportion of symptom free days<br> 2. Proportion of days without rescue medication<br> 3. Mean eye symptom score<br> 4. Total symptom score<br> 5. Rhinitis specific quality of life questionnaire (PARQLQ)<br> 6. Overall assessment of perceived benefit by child and parent over whole period<br>