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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02131038

Enrollment

Registered

2014-05-06

Start date

2009-05-01

Completion date

2009-09-01

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Ectoine, bitop, Allergic Rhinitis

Brief summary

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.

Interventions

OTHERMedica device, drug-like

Ectoin (R) Allergy Nasal Spray

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in combined nasal symptom Score	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.

Secondary

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

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORUwe Sonnemann, MD

HNO Praxis Elmshorn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026