Completed

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

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What is being tested

ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)

+ Placebo products

Device
Who is being recruted

Rhinitis, Allergic, Seasonal+7

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 5 to 17 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: April 2011
See protocol details

Summary

Principal SponsorBitop AG
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

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 TitleEvaluation 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
NCT01342601
Principal SponsorBitop AG
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Rhinitis, Allergic, SeasonalHypersensitivityHypersensitivity, ImmediateImmune System DiseasesNose DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesRhinitisRhinitis, Allergic

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
9 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

Kinderarzt Bleckmann

Baunatal-Großenritte, GermanyOpen Kinderarzt Bleckmann in Google Maps
Suspended

Dr. med. Martina Weh

Berlin, Germany
Suspended

Experimentelle Pneumologie RUB

Bochum, Germany
Suspended

Kinderarztpraxis Bramsche

Bramsche, Germany
Completed8 Study Centers