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van CCT (UK)


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van CCT (UK)


Sublingual immunotherapy with house dust mite allergen in children with allergic rhinitis: randomised double-blind placebo-controlled trial.


- candidate number1611
- NTR NumberNTR385
- ISRCTNISRCTN91141483
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleSublingual immunotherapy with house dust mite allergen in children with allergic rhinitis: randomised double-blind placebo-controlled trial.
- Scientific TitleSublingual immunotherapy with house dust mite allergen in children with allergic rhinitis: randomised double-blind placebo-controlled trial.
- ACRONYMSTARDROP II
- hypothesisNull hypothesis: sublingual immunotherapy with house dust mite allergen is as effective as placebo on daily symptoms in children with allergic rhinitis.
- Healt Condition(s) or Problem(s) studiedRhinitis , House dust mite allergy
- Inclusion criteria1. Age: 6-18 years;
2. History of allergic rhinitis for at least one year;
3. Positive RAST for house dust mite allergy (2+);
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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 19-sep-2005
- planned closingdate31-dec-2008
- Target number of participants256
- InterventionsSublingual immunotherapy (SLIT) with house dust mite allergen during 24-26 months.
- Primary outcomeMean rhinitis symptom score in September-December after 2 years of SLIT / placebo.
- Secondary outcome(all in September-December after 2 years of SLIT/placebo, except last outcome below)
1. Proportion of symptomfree days;
2. Proportion of days without recue medication;
3. Mean eye symptom score;
4. Total symptom score;
5. Rhintis specific quality of life questionnaire (PARQLQ);
6. Overall assessment of perceived benefit by child and parent over whole period.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. H. Moed
- CONTACT for SCIENTIFIC QUERIESDr. J.C. Woude, van der
- Sponsor/Initiator Artu Biologicals Europe B.V.
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD13-sep-2005 - 6-mrt-2006


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