Rhinitis, Allergic, SeasonalNCT01699165
Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)
A study testing Nasal filter in people with Rhinitis, Allergic, Seasonal, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to assess the effect of reducing exposure to allergens in patients with hay fever by means of a nasal filter. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Nasal filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Feb 2013
- 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 within 12 months of study enrollment.
- Written informed consent
- Reliable anticonception for fertile women
- Must be able to complete the study
- Forced Expiratory Volume at one second (FEV1) higher than 70 % of predicted value
- Positive grass immunoglobulin-E (IgE) blood sample equal to or higher than 3,50 kU/L
Who cannot join
- Positive pregnancy test for fertile women
- Asthma unless mild and only occurring in relation to the grass pollen season as assessed by the investigator
- Inadequate washout periods in regards to Environmental Exposure Unit (EEU) 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
- Use of long acting anti-histamines
- Documented evidence of acute or chronic sinusitis as determined by individual investigator
Show all 12Show fewer
- FEV1 lower than 70 % of predicted value
- Subjects with perennial allergic rhinitis (PAR) to e.g. house dust mites, cats, dogs moulds unless symptom free
- Allergic rhinitis requiring medication caused by allergens other than grass unless symptom free
- 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 septum perforations, nasal polyps, chronic nasal obstruction or other nasal diseases
- Receipt of immunotherapy with grass pollen within the previous 10 years
- 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, 8200
About this study
Official title: Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study
The purpose of this study is to assess the effect of reducing exposure to allergens in patients with hay fever by means of a nasal filter.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Nasal filter, Placebo nasal filter
- Keywords
- rhinitis, allergic, seasonal, double blind, doubleblind, randomized, randomised, placebo, crossover, clinical, nasal, filter, controlled, trial, hayfever, hay, fever, efficacy, safety, prevention
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal filterDevice
Active nasal filter
Placebo nasal filterDevice
Placebo nasal filter
| Study group | Role | What they receive |
|---|---|---|
| Placebo Nasal filter | Sham comparator | Placebo treatment Receives: Device: Placebo nasal filter |
| Nasal Filter | Active comparator | Active treatment Receives: Device: Nasal filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score
To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Nasal Symptom Score (TNSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.
Measured: Day 1 and day 15
Secondary outcomes (1)
Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry
To assess the effects of active nasal filters on intranasal volume in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter. The assessment will be based on the difference between minimum and maximum volume as determined by acoustic rhinometry measurements pre- and post-exposure on each study day. The statistical analysis will be a parametric paired t-test.
Measured: Day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Spirare 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
- NCT01699165
- Sponsor's protocol ID
- 1202-2
- Other IDs
- CIV-12-06-007121, 1-10-72-371-12.
- Status last verified
- Apr 2013
- First submitted
- 16 Aug 2012
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT01699165
- Acronym / sponsor ID
- 1202-2
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- rhinitis, allergic, seasonal, double blind, doubleblind, randomized, randomised, placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Spirare ApS
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Oct 2012 (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.
The purpose of this study is to assess the effect of reducing exposure to allergens in patients with hay fever by means of a nasal filter.
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 Nasal filter | Sham comparator | Device: Placebo nasal filterPlacebo treatment |
| Nasal Filter | Active comparator | Device: Nasal filterActive treatment |
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 within 12 months of study enrollment.
- Written informed consent
- Reliable anticonception for fertile women
- Must be able to complete the study
- Forced Expiratory Volume at one second (FEV1) higher than 70 % of predicted value
Key exclusion criteria (12 listed)
- Positive pregnancy test for fertile women
- Asthma unless mild and only occurring in relation to the grass pollen season as assessed by the investigator
- Inadequate washout periods in regards to Environmental Exposure Unit (EEU) 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
- Use of long acting anti-histamines
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 |
|---|---|---|
| Nasal filterActive nasal filter | Device | Nasal Filter |
| Placebo nasal filterPlacebo nasal filter | Device | Placebo Nasal filter |
Primary outcome
Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score
Time frame: Day 1 and day 15
To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Nasal Symptom Score (TNSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.
1 secondary outcome
Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry
Time frame: Day 1 and day 15
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 19 Apr 2013.
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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 Nasal filter in people with Rhinitis, Allergic, Seasonal, 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 19 Apr 2013. 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?
Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score (time frame: Day 1 and day 15). 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 19 Apr 2013.