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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Seasonal Allergic Rhinitis, Seasonal Allergic Conjunctivitis

Intervention / Treatment
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* Device: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)
* Device: Placebo products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 5-17 years diagnosed seasonal allergic rhinitis general good health condition other than SAR, and free of any concomitant conditions or treatment that could interfere with clinical investigation conduct, influence the interpretation of clinical investigation observations/results, or put the patient at increased risk during the clinical investigation Sum of Total Nasal Score (TNSS) ≥ 6 Sum of Total Ocular Score (TOSS) ≥ 4 Exclusion Criteria: - Confirmed diagnosis of acute or chronic rhinosinusitis, as determined by the investigator History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the screening visit) Chronic or intermittent use of intranasal, oral, intramuscular, intravenous or ophthalmic corticosteroids Ocular disorder other than allergic conjunctivitis, except hyperopia and myopia and strabismus Upper and lower airway respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within 4 weeks prior to clinical investigation start or development of a respiratory infection during the run-in period Start of specific immunotherapy within 1 month preceding enrolment in the clinical investigation or change in dose of immunotherapy throughout the trial Chronic moderate to severe asthma according to GINA criteria which is treated with inhaled corticosteroids (ICS) and additional anti-asthmatic treatment. Patients with mild co-seasonal asthma must not change their dose regimen of ICS within 4 weeks prior to the enrolment into the clinical investigation nor during the clinical investigation Other respiratory diseases (e.g. Chronic obstructive pulmonary disease (COPD), cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, emphysema, etc.) on investigators discretion

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ectoin products<br> | Device: ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)<br>* Comparison of ANS01 and AAT01 with placebo<br>* Other names: ect4allergy;|
| Placebo Comparator: Placebo products<br> | Device: Placebo products<br>* Nasal Spray and Eye drops without Ectoin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Symptom scores: Runny nose, itchy nose, nasal congestion, Sneezing, itchy ear, itchy eyes, red eyes, watery eyes | 2 weeks |