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

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray and Eye Drops in Patients With Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131051
• Other study ID #: REP-85
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: May 5, 2014
• Start date: June 2010
• Est. completion date: September 2010

Study information

• Verified date: May 2014
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis, Allergic
• Rhinitis

Locations

Country	Name	City	State
Germany	HNO Praxis Elmshorn	Elmshorn

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in primary allergic symptoms symptoms	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)	Day1, Day 7	No
Secondary	Palatal itching score		day 1 and day 7	No
Secondary	Efficacy and tolerability assessment by the patients	Patients assess the efficacy and tolerability separately based on a general an Scale from 0 to 8	day1 and day 7	Yes