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

Bitop

Status: Completed

Conditions: Allergic Rhinoconjunctivitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02131051

REP-85

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 2 patient groups

Azelastine group

Description:

Azelastine nasal spray Azelastine eye drops

Ectoin group

Description:

Ectoin Allergy Nasal Spray Ectoin Allergy Eye Drops