Evaluation of the Safety and Efficacy of Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops in the Treatment of Seasonal Allergic Rhinitis (SAR) in Children and Adolescents: a Multicenter, Double-blind, Randomised, Placebo Controlled, Parallel Group Clinical Investigation
Sponsor study identifier
interventional
72
1 country
8
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 21, 2011
Actual (reported)April 27, 2011
Actual (reported)September 2011
Actual (reported)September 2011
Actual (reported)clinically relevant changes in vital signs
2 weeks
Incidence of adverse events
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)
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
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
2 weeks
Use of rescue medication
2 weeks
TNSS, separately for a.m. and p.m. measurement over time
2 weeks
TOSS over time (V2, V3), separately for a.m. and p.m. measurement over time
2 weeks
Non-nasal score over time (V2, V3), separately for a.m. and p.m. measurement over time
2 weeks
Symptom scores separately for a.m. and p.m. measurement over time
2 weeks
Comparison of ANS01 and AAT01 with placebo
Nasal Spray and Eye drops without Ectoin
Kinderarzt Bleckmann
Baunatal-Großenritte, 34225, Germany
Dr. med. Martina Weh
Berlin, 13125, Germany
Experimentelle Pneumologie RUB
Bochum, 44789, Germany
Kinderarztpraxis Bramsche
Bramsche, 49565, Germany
Dr. med. Friedrich Kaiser
Hamburg, 22415, Germany
Dr. Marlies Bölich
Jena, 07745, Germany
Dr. Ralph Maier
Tuttlingen, 78532, Germany
Albrecht Bufe, Prof. Dr. med.
Experimentelle Pneumologie RUB
72 participants (actual enrollment reported by the registry).
First Submitted
April 21, 2011
First Posted
April 27, 2011
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
The Effects of Immunotherapy in the Nose
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
2 weeks
clinical relevant changes in physical examination parameters
2 weeks
Severity of Adverse events
2 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Dr.med. Dieter Schlegel und Lilli Hegai
Welzheim, 73642, Germany
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)Last Updated
October 13, 2011
Record last verified: 2011-10
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Source: ClinicalTrials.gov.
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