Sublingual immunotherapy with house dust mite allergen in children with allergic rhinitis: randomised double-blind placebo-controlled trial.
Recruiting
- Conditions
- allergic rhinitis related to house dust mite allergy
- Registration Number
- NL-OMON28314
- Lead Sponsor
- ARTU Biologicals Europe BV
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 256
Inclusion Criteria
1. Age: 6-18 years;
2. History of allergic rhinitis for at least one year;
Exclusion Criteria
1. Severe asthma;
2. Allergic sensitivity to pets, in case these are present in the family home;
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 (all in September-December after 2 years of SLIT/placebo, except last outcome below)<br /><br>1. Proportion of symptomfree days;<br /><br>2. Proportion of days without recue medication;<br /><br>3. Mean eye symptom score;<br /><br>4. Total symptom score;<br /><br>5. Rhintis specific quality of life questionnaire (PARQLQ);<br /><br>6. Overall assessment of perceived benefit by child and parent over whole period.