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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28314
Enrollment
256
Registered
2005-09-13
Start date
2005-09-19
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhinitis related to house dust mite allergy

Interventions

Sublingual immunotherapy (SLIT) with house dust mite allergen during 24-26 months.

Sponsors

ARTU Biologicals Europe BV
Lead Sponsor

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 (¡Ý2+); 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

MeasureTime frame
Mean rhinitis symptom score in September-December after 2 years of SLIT / placebo.

Secondary

MeasureTime frame
(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.

Contacts

Public ContactH. Moed

Erasmus Medical Center, Department of General Practice, P.O. Box 1738

h.moed@erasmusmc.nl+31 (0)10 4088194

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)