Seasonal Allergic RhinitisNCT02108574
Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever
A study testing Rhinix Nasal Filter in people with Seasonal Allergic Rhinitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis (hay fever) in a park setting. 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 Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Dec 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
- History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study entry. Documented by a positive skin test (wheal > 3mm) within 12 months of study enrolment.
- Written informed consent
- Must be able to complete the study
- Reliable anticonception for fertile women
- FEV1 higher than 70 % of predicted value
- Positive grass IgE blood sample higher or equal to 0,7 kU/L
Who cannot join
- Improper fit of the Rhinix™ device
- Nasal septal deviation
- Retrospective TNSS for last summer < 3
- Positive pregnancy test for fertile women
- Inadequate washout periods in regards to park study appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2 weeks), intranasal or systemic decongestants (3 days), intranasal or systemic antihistamines (3 days), Loratadine (10 days)).
- Rhinitis medicamentosa
Show all 12Show fewer
- Use of long acting anti-histamines.
- Documented evidence of acute or cronic sinusitis, as determined by the individual investigator.
- FEV1 lower than 70 % of predicted value
- Subjects with nasal conditions likely to affect the outcome of the study in the opinion of the investigator, i.e. anterior nasal septum deviation, nasal septal perforations, nasal polyps, chronic nasal obstruction or other nasal diseases.
- Receipt of immunotherapy with grass pollen within the previous 10 years (at least two rounds of treatment).
- Women who are breastfeeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Aarhus C, 8000
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Single-centre Crossover Park Study Assessing Rhinix™ Nasal Filters
This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis (hay fever) in a park setting.
Read the detailed description
The study will include 100 participants with grass allergy and will look at the efficacy and usability of RHINIX™ nasal filters on hay fever in a randomized, double-blind, placebo-controlled, crossover design.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Placebo Filter, Rhinix Nasal Filter
- 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.
Placebo FilterDevice
Rhinix Nasal FilterDevice
| Study group | Role | What they receive |
|---|---|---|
| Placebo Filter | Placebo comparator | Placebo device Receives: Device: Placebo Filter |
| Rhinix Nasal Filter | Active comparator | Actual Rhinix Nasal Filter Receives: Device: Rhinix Nasal Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo
Baseline recording at 09.00 Run-in recordings from 09.30-11.00 Daily Total Nasal Symptom Score evaluated from 11.00-17.00 with the last recording at 17.00, recordings at 30 minute increments.
Total Nasal Symptom Score is the sum of 4 symptoms (runny nose, blocked nose, itchy nose and sneezing) which are each evaluated on a scale of 0=none, 1=mild, 2=moderate, 3=severe symptoms
Measured: 11.00-17.00 with recordings at 30. minute increments.
Secondary outcomes (3)
To assess the change in Daily Throat Irritation between Rhinix™ and placebo
Baseline recording at 09.00 Run-in recording at. 10.00 Daily Throat Irritation evaluated from 11.00-17.00 with the last recording at 17.00, recordings at hourly increments.
Daily Throat Irritation is the sum of 6 symptom ratings on a Visual Analogue Scale.
Measured: 11.00-17.00 with hourly increments
To assess the correlation between maximum TNSS and difference in Daily TNSS
Daily TNSS is described in the Primary Efficacy Endpoint. Maximum TNSS is the single highest TNSS between 11.00 and 17.00
The correlation will be graphically shown using a Bland-Altman plot.
Measured: 11.00-17.00 at 30 minute increments
Change in Daily TNSS for subgroup
Subgroup analysis of change in daily TNSS between RHINIX and placebo for the subjects with at least one rating of TNSS ≥ 6 on at least one of the two study days.
See primary outcome measure for more details.
Measured: 11.00-17.00 at 30 minute increments
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 startApr 2014
- Primary completionDec 2014
- Study completionDec 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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Rhinix ApS
- Responsible party
- Sponsor
- Investigators
- Torben Sigsgaard, Professor, Principal investigator, Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108574
- Sponsor's protocol ID
- 1401
- Status last verified
- Dec 2014
- First submitted
- 18 Mar 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kenney P, Hilberg O, Laursen AC, Peel RG, Sigsgaard T. Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo-controlled crossover park study. J Allergy Clin Immunol. 2015 Dec;136(6):1566-1572.e5. doi: 10.1016/j.jaci.2015.05.015. Epub 2015 Jun 30.
PubMed 26141263
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Single-centre Crossover Park Study Assessing Rhinix™ Nasal Filters
- ClinicalTrials.gov ID
- NCT02108574
- Acronym / sponsor ID
- 1401
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Rhinix ApS
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 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 evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis (hay fever) in a park setting.
Detailed description
The study will include 100 participants with grass allergy and will look at the efficacy and usability of RHINIX™ nasal filters on hay fever in a randomized, double-blind, placebo-controlled, crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Filter | Placebo comparator | Device: Placebo FilterPlacebo device |
| Rhinix Nasal Filter | Active comparator | Device: Rhinix Nasal FilterActual Rhinix Nasal Filter |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study entry. Documented by a positive skin test (wheal > 3mm) within 12 months of study enrolment.
- Written informed consent
- Must be able to complete the study
- Reliable anticonception for fertile women
- FEV1 higher than 70 % of predicted value
Key exclusion criteria (12 listed)
- Improper fit of the Rhinix™ device
- Nasal septal deviation
- Retrospective TNSS for last summer < 3
- Positive pregnancy test for fertile women
- Inadequate washout periods in regards to park study appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2 weeks), intranasal or systemic decongestants (3 days), intranasal or systemic antihistamines (3 days), Loratadine (10 days)).
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 |
|---|---|---|
| Placebo Filter | Device | Placebo Filter |
| Rhinix Nasal Filter | Device | Rhinix Nasal Filter |
Primary outcome
To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo
Time frame: 11.00-17.00 with recordings at 30. minute increments.
Baseline recording at 09.00 Run-in recordings from 09.30-11.00 Daily Total Nasal Symptom Score evaluated from 11.00-17.00 with the last recording at 17.00, recordings at 30 minute increments. Total Nasal Symptom Score is the sum of 4 symptoms (runny nose, blocked nose, itchy nose and sneezing) which are each evaluated on a scale of 0=none, 1=mild, 2=moderate, 3=severe symptoms
3 secondary outcomes
To assess the change in Daily Throat Irritation between Rhinix™ and placebo
Time frame: 11.00-17.00 with hourly increments
To assess the correlation between maximum TNSS and difference in Daily TNSS
Time frame: 11.00-17.00 at 30 minute increments
Change in Daily TNSS for subgroup
Time frame: 11.00-17.00 at 30 minute increments
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 23 Dec 2014.
- Derived from this study: PubMed 26141263Kenney P, Hilberg O, Laursen AC, Peel RG, Sigsgaard T. Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo-controlled crossover park study. J Allergy Clin Immunol. 2015 Dec;136(6):1566-1572.e5. doi: 10.1016/j.jaci.2015.05.015. Epub 2015 Jun 30.
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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, Professor 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 Filter 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 6 inclusion and 12 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 23 Dec 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. Some participants in this study may receive a placebo. 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?
To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo (time frame: 11.00-17.00 with recordings at 30. minute increments.). 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 NCT02108574, 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 23 Dec 2014.