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Application of Ectoin Allergy Nasal Spray in Comparison to Beclomethasone Nasal Spray

NCT ID: NCT02133053

Last Updated: 2014-05-07

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

2011-05-31

Study Completion Date

2011-07-31

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 Beclomethasone nasal spray. The patient applies Ectoin® Rhinitis Nasal Spray or Beclomethasone 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 in daily by the patient in a dairy.

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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 (Medical Device, drug-like)

Medical Device, drug-like

Intervention Type OTHER

Ectoin Allergy Nasal Spray

Beclomethasone Group

Beclomethasone nasal spray

Beclomethasone

Intervention Type DRUG

Beclomethasone nasal spray

Interventions

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Medical Device, drug-like

Ectoin Allergy Nasal Spray

Intervention Type OTHER

Beclomethasone

Beclomethasone nasal spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed allergic rhinitis during the observational period

Exclusion Criteria

* 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

Other Identifiers

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PPL-042

Identifier Type: -

Identifier Source: org_study_id

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