Allergic RhinitisNCT02133053
Application of Ectoin Allergy Nasal Spray in Comparison to Beclomethasone Nasal Spray
An observational study of Allergic Rhinitis, run by Bitop AG.
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 Beclomethasone nasal spray. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Medical Device, drug-like and Beclomethasone
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jul 2011
- 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
- Diagnosed allergic rhinitis during the observational period
Who cannot join
- Contra indications according to the label
About this study
Official title: Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray
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 Beclomethasone nasal spray. The patient applies Ectoin® Rhinitis Nasal Spray or Beclomethasone 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 in daily by the patient in a dairy.
- Conditions
- Allergic Rhinitis
- Being tested
- Medical Device, drug-like, Beclomethasone
- Keywords
- Allergic Rhinitis, Ectoine, bitop, Ectoin
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device, drug-likeOther
Ectoin Allergy Nasal Spray
BeclomethasoneDrug
Beclomethasone nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Ectoin Group | Ectoin Allergy Nasal Spray (Medical Device, drug-like) Receives: Other: Medical Device, drug-like | |
| Beclomethasone Group | Beclomethasone nasal spray Receives: Drug: Beclomethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Nasal Symptom Score
Measured: Time Frame: day 1, day 7, day 14
Secondary outcomes (3)
Change in palatal itching score
Measured: Day 1, 7 and 14
Efficacy and tolerability assessment by the patients and by the investigator
Measured: day 7 and 14
Change in quality of life assessed by Rhinitis Quality of Life Questionnaire
Measured: Day1 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 posted7 May 2014 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionJul 2011
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
- NCT02133053
- Sponsor's protocol ID
- PPL-042
- Status last verified
- May 2014
- First submitted
- 2 May 2014
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray
- ClinicalTrials.gov ID
- NCT02133053
- Acronym / sponsor ID
- PPL-042
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Ectoine, bitop, Ectoin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 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 Beclomethasone nasal spray. The patient applies Ectoin® Rhinitis Nasal Spray or Beclomethasone 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 in daily by the patient in a dairy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoin Group | – | Other: Medical Device, drug-likeEctoin Allergy Nasal Spray (Medical Device, drug-like) |
| Beclomethasone Group | – | Drug: BeclomethasoneBeclomethasone nasal spray |
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 (1 listed)
- Diagnosed allergic rhinitis 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 |
|---|---|---|
| Medical Device, drug-likeEctoin Allergy Nasal Spray | Other | Ectoin Group |
| BeclomethasoneBeclomethasone nasal spray | Drug | Beclomethasone Group |
Primary outcome
Change in Total Nasal Symptom Score
Time frame: Time Frame: day 1, day 7, day 14
3 secondary outcomes
Change in palatal itching score
Time frame: Day 1, 7 and 14
Efficacy and tolerability assessment by the patients and by the investigator
Time frame: day 7 and 14
Change in quality of life assessed by Rhinitis Quality of Life Questionnaire
Time frame: Day1 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 7 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
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Bitop AG.
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 1 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 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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 Total 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 7 May 2014.