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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ectoin products | Active Comparator |
| |
| Placebo products | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01) | Device | Comparison of ANS01 and AAT01 with placebo |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albrecht Bufe, Prof. Dr. med. | Experimentelle Pneumologie RUB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinderarzt Bleckmann | Baunatal-GroĂźenritte | 34225 | Germany | |||
| Dr. med. Martina Weh |
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| Placebo products | Device | Nasal Spray and Eye drops without Ectoin |
|
| 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 |
| 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 |
| Dr.med. Dieter Schlegel und Lilli Hegai | Welzheim | 73642 | Germany |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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