CClinicalTrials.gg
CompletedNCT02131038Updated Jan 29, 2026

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

An observational study in Allergic Rhinitis, sponsored by Bitop AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Bitop AG · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Rhinitis

Browse trials for

Keywords

  • Ectoine
  • bitop
  • Allergic Rhinitis
03

In context

Rhinitis, Allergic

1,030 studies on the registry are indexed under Rhinitis, Allergic; 89 are open to participants now.

This study's enrollment of 50 is below the median of 126 across 156 observational studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Bitop AG is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary Care Clinic

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

Exclusion Criteria:

  • Contra indications according to the label
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Ectoin group

    Ectoin Allergy Nasal Spray

    Other: Medica device, drug-like

  • Cromolyn group

    Cromolyn sodium

Interventions

  • OtherMedica device, drug-like

    Ectoin (R) Allergy Nasal Spray

06

What researchers measure

Primary outcomes

  1. Change in combined nasal symptom Score

    The change in the sum of the three different parameters nasal congestion, rhinorrhea and nasal errhine were investigated as combined score.

    Time frame: Time Frame: day 1, day 7, day 14

Secondary outcomes

  1. Patient's and physician's judgment of efficacy

    Patient and physician were asked to grade the efficacy of the treatment on a scale from 0 to 8.

    Time frame: Day 7 and 14

  2. Eye itching score,

    Time frame: Day 1, 7, 14

  3. Epiphora score

    Time frame: Day1, Day 7 and Day 14

  4. Conjunctivitis score,

    Time frame: Day 1, Day 7 Day 10

  5. Palatal itching score

    Time frame: Day 1, Day 7, Day 14

  6. Nasal muscle hyperplasia score

    Time frame: Day 1, Day 7 and Day 14

07

Study locations

1 site
  • HNO Praxis Elmshorn
    Elmshorn, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02131038
Lead sponsor
Bitop AG
Responsible party
Sponsor
First posted
May 6, 2014
Start date
May 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jan 29, 2026

Study contacts

Uwe Sonnemann, MD
principal investigator · HNO Praxis Elmshorn

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion