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

Information source: Bitop AG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Rhinoconjunctivitis

Phase: N/A

Status: Completed

Sponsored by: Bitop AG

Official(s) and/or principal investigator(s):
Uwe Sonnemann, MD, Principal Investigator, Affiliation: HNO Praxis Elmshorn


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 EctoinŽ 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.

Clinical Details

Official title: Non-interventional Study: Application of EctoinŽ Rhinitis Nasal Spray and Eye Drops in Patients With Allergic Rhinitis

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Change in primary allergic symptoms symptoms

Secondary outcome:

Palatal itching score

Efficacy and tolerability assessment by the patients


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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'


- contra indications according to the label

Locations and Contacts

HNO Praxis Elmshorn, Elmshorn, Germany
Additional Information

Starting date: June 2010
Last updated: May 5, 2014

Page last updated: August 23, 2015

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