A multicenter, randomised, controlled, double-blind study to evaluate efficacy and safety of a perennial sublingual specific immunotherapy with a solution of grass pollen allergen extract in children with clinically relevant grass pollen sensitivity in comparison to a symptomatic standard treatment with add on placebo
- Conditions
- IgE-mediated allergic disease manifested as symptoms of allergic rhinitis/rhinoconjunctivitis with or without allergic bronchial asthma (GINA I and II), triggered by grass pollen allergens.MedDRA version: 9.1Level: LLTClassification code 10036019Term: Pollen allergy
- Registration Number
- EUCTR2006-005911-82-PL
- Lead Sponsor
- Allergopharma Joachim Ganzer KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 230
•Male and female outpatients
•Age 4 – < 12 years
•IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without asthma
bronchiale (GINA stage I or II), attributable to grass pollen allergens, documented
by
?positive skin prick test weal for grass pollen at least as large as
histaminedihydrochloride (1 %) control reaction or > 5 mm in diameter and
?positive RAST/CAP > 2 to grass pollens and
?proven clinical relevance of grass pollen allergy by positive conjunctival
provocation testing with grass pollen allergens
•For female patients with childbearing potential: Negative pregnancy test and
effective contraception
•For patients with Asthma bronchiale at entry: specialist confirmed diagnosis and
asthma classification as GINA grade I or II
•Written informed consent
At the Beginning of the treatment phase:
•Patients must have demonstrated a symptom score of at least 4 every day during
the week following the peak pollen count in the baseline season
•Rhinitis / Rhinoconjunctivitis symptoms documented in the patient´s diary during
the baseline season
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 or other current specific immunotherapy with grass pollen allergens in any
formulation
•Symptoms related to or strong skin test positivity to other seasonal or perennial
allergens (skin prick test weal > 5 mm and/or as large as histaminedihydrochloride
(1%) control reaction, if clinical relevance cannot be excluded), which are effective
in the same period as the relevant grass pollens (June – August)
•Previous course of hyposensitisation against grass pollen or other allergens that
are not known
•Specific immunotherapy with any other allergens during the course of the study
•Patients that have undergone an unsuccessful course of specific immunotherapy
with any allergen
•Clinically relevant rhinoconjunctival or respiratory symptoms related to other
reasons
•Peak Flow < 80% of predicted normal (ECCS)
•Severe bronchial asthma (GINA grade III and IV)
•Allergy treatment according to severity of symptoms with other than the following
medication during the grass pollen season: Levocabastine nasal spray/eye drops,
Loratadine tablets, Cetirizine juice / tablets, Salbutamol and short course
treatments on prescription with nasal corticosteroids or oral corticosteroids.
•Febrile infections or inflammation of the respiratory tract at the time of inclusion
•Severe acute or chronic diseases, severe inflammatory diseases (liver, kidneys,
metabolic diseases)
•Autoimmune diseases, immune-defects including immuno-suppression, immune-
complex-induced immunopathies
•Previous or ongoing use of anti-IGE antibodies, tranquilizers or psychoactive
medicine
•Severe psychiatric and psychological disorders including impairment of cooperation
(e.g. alcohol or drug abuse)
•Treatment with ß-blockers
•Recurrent seizures
•Pregnancy and lactation period
•Concurrent participation in any other clinical trial or participation in any other clinical
trial during the previous 30 days
•Low compliance or inability to understand instructions/study documents
•Patients being in any relationship of dependence with the sponsor and/or with the
investigator
•Patients, who are institutionalised due to a official or judicial order
•Mentally disabled minors
•Contra-indications for application of adrenaline (e.g. severe acute or chronic
symptomatic coronary heart disease, severe arterial hypertension)
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