Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray in Patients With Allergic Rhinitis

Completed

• Conditions: Allergic Rhinitis
• Interventions: Other: Medica device, drug-like

• Registration Number: NCT02131038
• 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. In addition the effectiveness and safety shall be compared to a Cromoglycid acid containing nasal spray. The patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and by the patient in a dairy at defined time intervalls.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-09
• Study Completion: 2009-09
• 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: 50

Inclusion Criteria

• Female or male individuals ≥ 18 years
• Patients with proven Allergic Rhinitis which are treated with Ectoin Nasal Spray or -Cromoglycic acid nasal Spray during the observational period

Exclusion Criteria

• Contra indications according to the label

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ectoin group	Medica device, drug-like	Ectoin Allergy Nasal Spray

Primary Outcome Measures

Name	Time	Method
Change in combined nasal symptom Score	Time Frame: day 1, day 7, day 14	The change in the sum of the three different parameters nasal congestion, rhinorrhea and nasal errhine were investigated as combined score.

Secondary Outcome Measures

Name	Time	Method
Patient's and physician's judgment of efficacy	Day 7 and 14	Patient and physician were asked to grade the efficacy of the treatment on a scale from 0 to 8.
Eye itching score,	Day 1, 7, 14
Epiphora score	Day1, Day 7 and Day 14
Conjunctivitis score,	Day 1, Day 7 Day 10
Palatal itching score	Day 1, Day 7, Day 14
Nasal muscle hyperplasia score	Day 1, Day 7 and Day 14

Trial Locations

Locations (1)

HNO Praxis Elmshorn; 🇩🇪 Elmshorn, Germany