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

May 6, 2014 updated by: Bitop AG

Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

Inclusion Criteria:

  • Diagnosed allergic rhinitis during the observational period

Exclusion Criteria:

  • Contra indications according to the label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ectoin Group
Ectoin Allergy Nasal Spray (Medical Device, drug-like)
Other: Medical Device, drug-like
Ectoin Allergy Nasal Spray
Beclomethasone Group
Beclomethasone nasal spray
Drug: Beclomethasone
Beclomethasone nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Total Nasal Symptom Score
Time Frame: Time Frame: day 1, day 7, day 14
Time Frame: day 1, day 7, day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in palatal itching score
Time Frame: Day 1, 7 and 14
Day 1, 7 and 14
Efficacy and tolerability assessment by the patients and by the investigator
Time Frame: day 7 and 14
day 7 and 14
Change in quality of life assessed by Rhinitis Quality of Life Questionnaire
Time Frame: Day1 and Day 14
Day1 and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitop AG

Investigators

  • Principal Investigator: Uwe Sonnemann, MD, HNO Praxis Elmshorn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPL-042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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