Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis

Completed

• Conditions: Allergic Rhinoconjunctivitis

• Registration Number: NCT02131051
• Lead Sponsor: Bitop AG

Brief Summary

This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes Azelastine nasals spray and eye drops according to the instructions for use. The observation takes place over a period of 7 days. Response to treatment is recorded at day 7 by the physician and in daily by the patient in a dairy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2014-04-25
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-05
• Last Update Submitted: 2014-05-05
• Study First Posted: 2014-05-06
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• male or female patients
• aged 18-70 years
• Patients with proven allergy and acute symptoms in nose and eye which are treated with Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal Spray and Azelastine Eye Drops during the observational period

Exclusion Criteria

• pregnancy and nursing women,
• drug addicts and persons unable to give consent to study participation,
• patients with intolerance against ingredients of any of the study treatments,
• previous eye or nose surgery,
• concomitant treatment with anti-allergic drugs, and
• diseases which might influence the output of the study according to the physicians' judgment.
• contra indications according to the label

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in primary allergic symptoms symptoms	Day1, Day 7	Change in the primary allergic nasal and ophthalmic symptoms: Degree of nasal breathing impairment, Rhinorrhea, Frequency of sneezing, Nasal itching,Eye itching, Watery eyes, Conjunctivitis score (eye redness)

Secondary Outcome Measures

Name	Time	Method
Palatal itching score	day 1 and day 7
Efficacy and tolerability assessment by the patients	day1 and day 7	Patients assess the efficacy and tolerability separately based on a general an Scale from 0 to 8

Trial Locations

Locations (1)

HNO Praxis Elmshorn; 🇩🇪 Elmshorn, Germany