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

NCT ID: NCT02131051

Last Updated: 2014-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinoconjunctivitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Azelastine group

Azelastine nasal spray Azelastine eye drops

No interventions assigned to this group

Ectoin group

Ectoin Allergy Nasal Spray Ectoin Allergy Eye Drops

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitop AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uwe Sonnemann, MD

Role: PRINCIPAL_INVESTIGATOR

HNO Praxis Elmshorn

Locations

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HNO Praxis Elmshorn

Elmshorn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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REP-85

Identifier Type: -

Identifier Source: org_study_id

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