Efficacy and Safety of Sublingual Immunotherapy with Ultra-Rush Titration in Children with Allergic Rhinoconjunctivitis to Tree Pollen, a Multicentre DBPC Trial - SLIT Efficacy Childre
- Conditions
- Allergic rhinitis against birch pollen
- Registration Number
- EUCTR2004-002350-63-DE
- Lead Sponsor
- Stallergenes GmbH & Co.KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
Female or male patients aged 6 - 14 with allergic rhinitis and/or allergic rhinoconjunctivitis
Clinical sensitisation to tree pollen (birch and possible alder and/or hazel) Sensitisation to further aeroallergens and to mites, cat and dog and further seasonal allergic rhinitis and seasonal mild or moderate allergic asthma are considered as not relevant
Positive clinical history of tree pollen (birch and possible alder and/or hazel), proven by:
- the majority of clinical symptoms appearing duringthe appropriate season for birch pollen (and possible alder and/or hazel pollen season);
- positive skin prick test (wheal diameter > 3 mm) and presence of specific IgE (positive CAP RAST class II and above);
- planned antiallergic or antiasthmatic treatment with the following drugs: local Levocabastine (nose, eye) oral Cetirizine, nasal Fluticasone;
Total symptom score on the RRTSS during the previous pollen season of greater than or equal to 8
Compliant patient (respectively the parents or the legal guardians of the patient) being able to complete a diary card for self evaluation of the symptoms and antisymptomatic medication
Signed and dated Patient’s informed consent for patients aged 12 and older as well as an signed and dated informed consent by the parents or legal guardians
Safety laboratory results within the normal range or considered as not clinically significant.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Previous immunotherapy with hazel pollen, alder pollen and/or birch pollen extracts within the last 3 years
Perennial allergic rhinitis
Perennial allergic asthma
Simultaneous participation in other clinical trials
Other reasons contra-indicating an inclusion into the trial according to the Investigator’s estimation (poor compliance)
Active tuberculosis
Auto - immune disorders
Severe chronic-inflammatory diseases
Malignancy
Irreversible secondary disorders at the target organ (emphysema, bronchoectasis)
Patients treated with b-blockers
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method