NCT01342601

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Bitop AG · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Seasonal Allergic Rhinitis
• Seasonal Allergic Conjunctivitis

Interventions

Type	Name	Description
DEVICE	ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)	Comparison of ANS01 and AAT01 with placebo
DEVICE	Placebo products	Nasal Spray and Eye drops without Ectoin

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-04-27
• Last updated: 2011-10-13

Locations

8 sites across 1 country: Germany