Seasonal Allergic RhinitisNCT02108379
Compliance and Usability Study Evaluating RHINIX™ Nasal Filters
A study testing Rhinix Nasal Filters in people with Seasonal Allergic Rhinitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in Denmark. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Rhinix Nasal Filters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,073 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Jul 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motivated to try a different treatment approach to seasonal allergic rhinitis (documented by answering the call-out by Astma-Allergi Danmark)
- Indicates having seasonal allergic rhinitis to grass via online questionnaire
- Informed consent (by email acceptance after having received information on the trial)
- Assess to internet and email
Who cannot join
- Improper fit of the Rhinix™ device
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Aarhus, 8000
About this study
Official title: An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters
This study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in Denmark.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Rhinix Nasal Filters
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhinix Nasal FiltersDevice
| Study group | Role | What they receive |
|---|---|---|
| Rhinix Nasal Filters | Experimental | All included will receive rhinix nasal filters Receives: Device: Rhinix Nasal Filters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Week 1 likelihood of continued use of RHINIX after study end.
In week 1: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.
Measured: 1 assessment at the end of the 1st week of use.
Week 2 likelihood of continued use of RHINIX after study end.
In week 2: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.
Measured: 1 assessment at the end of the 2nd week of use.
Secondary outcomes (4)
Week 1 Satisfaction with RHINIX
In week 1: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.
Measured: 1 assessment at the end of the 1st week
Week 2 satisfaction with RHINIX
In week 2: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.
Measured: One assessment at the end of the 2nd week
Week 1: RHINIX Control
In week 1: The proportion of subjects who state that RHINIX has helped "to a very high degree" or "to a high degree" in controlling their hay fever symptoms given that they have used the product
Measured: One assessment at the end of the 1st week of use
Week 2: RHINIX Control
In week 2: The proportion of subjects who state that RHINIX has helped "to a very high degree" or "to a high degree" in controlling their hay fever symptoms given that they have used the product
Measured: One assessment at the end of the 2nd week of use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Rhinix ApS, Astma-Allergi Danmark
- Responsible party
- Sponsor
- Investigators
- Torben Sigsgaard, Prof MD, Principal investigator, Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108379
- Sponsor's protocol ID
- 00002
- Status last verified
- Mar 2014
- First submitted
- 18 Mar 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kenney P, Hilberg O, Sigsgaard T. Clinical Application of Nasal Filters: An Observational Study on the Usability of Nasal Filters in Managing Seasonal Allergic Rhinitis. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):445-452.e4. doi: 10.1016/j.jaip.2016.01.003. Epub 2016 Feb 18.
PubMed 26897304
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters
- ClinicalTrials.gov ID
- NCT02108379
- Acronym / sponsor ID
- 00002
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,073 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Rhinix ApS, Astma-Allergi Danmark
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Apr 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 study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in Denmark.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rhinix Nasal Filters | Experimental | Device: Rhinix Nasal FiltersAll included will receive rhinix nasal filters |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Motivated to try a different treatment approach to seasonal allergic rhinitis (documented by answering the call-out by Astma-Allergi Danmark)
- Indicates having seasonal allergic rhinitis to grass via online questionnaire
- Informed consent (by email acceptance after having received information on the trial)
- Assess to internet and email
Key exclusion criteria (1 listed)
- Improper fit of the Rhinix™ device
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 |
|---|---|---|
| Rhinix Nasal Filters | Device | Rhinix Nasal Filters |
Primary outcome
Week 1 likelihood of continued use of RHINIX after study end.
Time frame: 1 assessment at the end of the 1st week of use.
In week 1: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.
Week 2 likelihood of continued use of RHINIX after study end.
Time frame: 1 assessment at the end of the 2nd week of use.
In week 2: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.
4 secondary outcomes
Week 1 Satisfaction with RHINIX
Time frame: 1 assessment at the end of the 1st week
Week 2 satisfaction with RHINIX
Time frame: One assessment at the end of the 2nd week
Week 1: RHINIX Control
Time frame: One assessment at the end of the 1st week of use
Week 2: RHINIX Control
Time frame: One assessment at the end of the 2nd week of use.
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 11 Nov 2014.
- Derived from this study: PubMed 26897304Kenney P, Hilberg O, Sigsgaard T. Clinical Application of Nasal Filters: An Observational Study on the Usability of Nasal Filters in Managing Seasonal Allergic Rhinitis. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):445-452.e4. doi: 10.1016/j.jaip.2016.01.003. Epub 2016 Feb 18.
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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.
Torben Sigsgaard, Prof MD principal investigator
Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinix Nasal Filters in people with Seasonal Allergic Rhinitis, run by University of Aarhus at 1 site in Denmark.
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 4 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 11 Nov 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 Denmark. 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?
Week 1 likelihood of continued use of RHINIX after study end. (time frame: 1 assessment at the end of the 1st week of use.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02108379, which also lists 1 linked publication.
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 11 Nov 2014.