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

January 27, 2026 updated by: Bitop AG

Non Interventional, Open Label Trial of Ectoine Containing Nasal Spray in Comparison With Cromoglycic Acid Containing Nasal Spray in Patients With Allergic Rhinitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Elmshorn, Germany
        • HNO Praxis Elmshorn

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

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

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
Other: Medica device, drug-like
Ectoin (R) Allergy Nasal Spray
Cromolyn group
Cromolyn sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in combined nasal symptom Score
Time Frame: Time Frame: day 1, day 7, day 14
The change in the sum of the three different parameters nasal congestion, rhinorrhea and nasal errhine were investigated as combined score.
Time Frame: day 1, day 7, day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's and physician's judgment of efficacy
Time Frame: Day 7 and 14
Patient and physician were asked to grade the efficacy of the treatment on a scale from 0 to 8.
Day 7 and 14
Eye itching score,
Time Frame: Day 1, 7, 14
Day 1, 7, 14
Epiphora score
Time Frame: Day1, Day 7 and Day 14
Day1, Day 7 and Day 14
Conjunctivitis score,
Time Frame: Day 1, Day 7 Day 10
Day 1, Day 7 Day 10
Palatal itching score
Time Frame: Day 1, Day 7, Day 14
Day 1, Day 7, Day 14
Nasal muscle hyperplasia score
Time Frame: Day 1, Day 7 and Day 14
Day 1, Day 7 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, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimated)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rep-25

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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