Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection against external agents like aeroallergens. The effects of Ectoin containing nasal spray and eye drops have already been demonstrated in several studies with adult Seasonal Allergic Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of allergic rhinitis without resulting in any significant adverse events. The aim of this clinical investigation is to demonstrate the safety, tolerability and efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR patients. It is assumed that Ectoin containing products show an excellent safety profile and very good tolerability together with a potent efficacy in the treatment of SAR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
Comparison of ANS01 and AAT01 with placebo
Nasal Spray and Eye drops without Ectoin
Kinderarzt Bleckmann
Baunatal-Großenritte, Germany
Dr. med. Martina Weh
Berlin, Germany
Experimentelle Pneumologie RUB
Bochum, Germany
Kinderarztpraxis Bramsche
Bramsche, Germany
Dr. med. Friedrich Kaiser
Hamburg, Germany
Dr. Marlies Bölich
Jena, Germany
Dr. Ralph Maier
Tuttlingen, Germany
Dr.med. Dieter Schlegel und Lilli Hegai
Welzheim, Germany
clinically relevant changes in vital signs
Time frame: 2 weeks
Incidence of adverse events
Time frame: 2 weeks
Overall assessment by the patient (Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ for children aged 5-12 years or AdolRQLQ for adolescents aged 13-17 years)
Time frame: 2 weeks
Change score in TNSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Total nasal symptom score: runny nose (anterior rhinorrhea/postnasal drainage), itchy nose, nasal congestion (stuffy nose) and sneezing on a 4 point scale (0=none to 3= severe)asssessed by the patient/caregiver
Time frame: 2 weeks
Change score in TOSS at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Total ocular symptom score: itchy eyes, red eyes, watery eyes´on a 4 point scale (0=none to 3=severe) assessed by the patient/caregiver
Time frame: 2 weeks
Change score in non-nasal score at visit V3 compared to baseline (V2) separately for a.m. and p.m. measurement
Non-nasal score: itchy ear/palate on a 4 point scale (0=none to 3=severe)assessed by the patient/caregiver
Time frame: 2 weeks
clinical relevant changes in physical examination parameters
Time frame: 2 weeks
Severity of Adverse events
Time frame: 2 weeks
Use of rescue medication
Time frame: 2 weeks
TNSS, separately for a.m. and p.m. measurement over time
Time frame: 2 weeks
TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time
Time frame: 2 weeks
Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time
Time frame: 2 weeks
Symptom scores separately for a.m. and p.m. measurement over time
Symptom scores: Runny nose, itchy nose, nasal congestion, Sneezing, itchy ear, itchy eyes, red eyes, watery eyes
Time frame: 2 weeks
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