Allergic RhinoconjunctivitisNCT02131051
Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis
An observational study of Allergic Rhinoconjunctivitis, 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 and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Sep 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- male or female patients
- aged 18-70 years
- Patients with proven allergy and acute symptoms in nose and eye which are treated with Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal Spray and Azelastine Eye Drops during the observational period
Who cannot join
- pregnancy and nursing women,
- drug addicts and persons unable to give consent to study participation,
- patients with intolerance against ingredients of any of the study treatments,
- previous eye or nose surgery,
- concomitant treatment with anti-allergic drugs, and
- diseases which might influence the output of the study according to the physicians' judgment.
- contra indications according to the label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray and Eye Drops 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 and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes Azelastine nasals spray and eye drops according to the instructions for use. The observation takes place over a period of 7 days. Response to treatment is recorded at day 7 by the physician and in daily by the patient in a dairy.
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- ectoine, allergic rhinitis, bitop
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Azelastine group | Azelastine nasal spray Azelastine eye drops | |
| Ectoin group | Ectoin Allergy Nasal Spray Ectoin Allergy Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in primary allergic symptoms symptoms
Change in the primary allergic nasal and ophthalmic symptoms:
Degree of nasal breathing impairment, Rhinorrhea, Frequency of sneezing, Nasal itching,Eye itching, Watery eyes, Conjunctivitis score (eye redness)
Measured: Day1, Day 7
Secondary outcomes (2)
Palatal itching score
Measured: day 1 and day 7
Efficacy and tolerability assessment by the patients
Patients assess the efficacy and tolerability separately based on a general an Scale from 0 to 8
Measured: day1 and day 7
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 startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies 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
- 48 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
- NCT02131051
- Sponsor's protocol ID
- REP-85
- Status last verified
- May 2014
- First submitted
- 25 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray and Eye Drops in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02131051
- Acronym / sponsor ID
- REP-85
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- ectoine, allergic rhinitis, bitop
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (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 and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes Azelastine nasals spray and eye drops according to the instructions for use. The observation takes place over a period of 7 days. Response to treatment is recorded at day 7 by the physician and in daily by the patient in a dairy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azelastine group | – | –Azelastine nasal spray Azelastine eye drops |
| Ectoin group | – | –Ectoin Allergy Nasal Spray Ectoin Allergy Eye Drops |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (3 listed)
- male or female patients
- aged 18-70 years
- Patients with proven allergy and acute symptoms in nose and eye which are treated with Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal Spray and Azelastine Eye Drops during the observational period
Key exclusion criteria (7 listed)
- pregnancy and nursing women,
- drug addicts and persons unable to give consent to study participation,
- patients with intolerance against ingredients of any of the study treatments,
- previous eye or nose surgery,
- concomitant treatment with anti-allergic drugs, and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in primary allergic symptoms symptoms
Time frame: Day1, Day 7
Change in the primary allergic nasal and ophthalmic symptoms: Degree of nasal breathing impairment, Rhinorrhea, Frequency of sneezing, Nasal itching,Eye itching, Watery eyes, Conjunctivitis score (eye redness)
2 secondary outcomes
Palatal itching score
Time frame: day 1 and day 7
Efficacy and tolerability assessment by the patients
Time frame: day1 and day 7
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 6 May 2014.
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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 Rhinoconjunctivitis, 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 3 inclusion and 7 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 6 May 2014. 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 primary allergic symptoms symptoms (time frame: Day1, Day 7). 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 6 May 2014.