Allergic RhinitisNCT02131038
Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray in Patients With Allergic Rhinitis
An observational study of Allergic Rhinitis, run by Bitop AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Medica device, drug-like
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- 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
Who cannot join
- Contra indications according to the label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Medica device, drug-like
- Keywords
- Ectoine, bitop, Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medica device, drug-likeOther
Ectoin (R) Allergy Nasal Spray
| Study group | Role | What they receive |
|---|---|---|
| Ectoin group | Ectoin Allergy Nasal Spray Receives: Other: Medica device, drug-like | |
| Cromolyn group | Cromolyn sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: day 1, day 7, day 14
Secondary outcomes (6)
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.
Measured: Day 7 and 14
Eye itching score,
Measured: Day 1, 7, 14
Epiphora score
Measured: Day1, Day 7 and Day 14
Conjunctivitis score,
Measured: Day 1, Day 7 Day 10
Palatal itching score
Measured: Day 1, Day 7, Day 14
Nasal muscle hyperplasia score
Measured: Day 1, Day 7 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwe Sonnemann, MD, Principal investigator, HNO Praxis Elmshorn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131038
- Sponsor's protocol ID
- Rep-25
- Status last verified
- Jan 2026
- First submitted
- 25 Apr 2014
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional, Open Label Trial of Ectoine Containing Nasal Spray in Comparison With Cromoglycic Acid Containing Nasal Spray in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02131038
- Acronym / sponsor ID
- Rep-25
- Conditions
- Allergic Rhinitis
- Keywords
- Ectoine, bitop, Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoin group | – | Other: Medica device, drug-likeEctoin Allergy Nasal Spray |
| Cromolyn group | – | –Cromolyn sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Contra indications according to the label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medica device, drug-likeEctoin (R) Allergy Nasal Spray | Other | Ectoin group |
Primary outcome
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.
6 secondary outcomes
Patient's and physician's judgment of efficacy
Time frame: Day 7 and 14
Eye itching score,
Time frame: Day 1, 7, 14
Epiphora score
Time frame: Day1, Day 7 and Day 14
Conjunctivitis score,
Time frame: Day 1, Day 7 Day 10
Palatal itching score
Time frame: Day 1, Day 7, Day 14
Nasal muscle hyperplasia score
Time frame: Day 1, Day 7 and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Sonnemann, MD principal investigator
HNO Praxis Elmshorn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Bitop AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in combined nasal symptom Score (time frame: Time Frame: day 1, day 7, day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.