Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray in Patients With Allergic Rhinitis

NCT ID: NCT02131038

Last Updated: 2026-01-29

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

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. In addition the effectiveness and safety shall be compared to a Cromoglycid acid containing nasal spray. The patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and by the patient in a dairy at defined time intervalls.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ectoin group

Ectoin Allergy Nasal Spray

Medica device, drug-like

Intervention Type OTHER

Ectoin (R) Allergy Nasal Spray

Cromolyn group

Cromolyn sodium

No interventions assigned to this group

Interventions

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Medica device, drug-like

Ectoin (R) Allergy Nasal Spray

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female or male individuals ≥ 18 years
* Patients with proven Allergic Rhinitis which are treated with Ectoin Nasal Spray or -Cromoglycic acid nasal Spray during the observational period

Exclusion Criteria

* Contra indications according to the label
Minimum Eligible Age

18 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-25

Identifier Type: -

Identifier Source: org_study_id

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