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

Last updated: May 5, 2014
Sponsor: Bitop AG
Overall Status: Completed

Phase

N/A

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT02131051
REP-85
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male or female patients

  • aged 18-70 years

  • Patients with proven allergy and acute symptoms in nose and eye which are treated withEctoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal Spray andAzelastine Eye Drops during the observational period

Exclusion

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

Total Participants: 48
Study Start date:
June 01, 2010
Estimated Completion Date:
September 30, 2010

Connect with a study center

  • HNO Praxis Elmshorn

    Elmshorn,
    Germany

    Site Not Available

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