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Respur.frThe reduction of rhinitis symptoms by nasal ﬁlters during naturalexposure to ragweed and grass pollen Background: Prototype nasal ﬁlters were developed to collect inhaled pollen.
This study evaluated the eﬃcacy of the ﬁlters for prevention of rhinitis symp- toms during acute outdoor pollen exposure.
Methods: A randomized double-blind design was used. Subjects (n ¼ 46) with a 1Woolcock Institute of Medical Research, Royal history of autumn exacerbation of rhinitis and positive skin test to ragweed, Prince Alfred Hospital, University of Sydney, New Bermuda and/or Bahia grass wore either active or placebo nasal ﬁlters for 2 h in autumn in a park containing these species. Major and Total Symptoms scores Department of Rural Health, University of Sydney were recorded at 0, 30, 60, 90 and 120 min.
and Northern Rivers Area Health Service, LismoreNew South Wales, Australia Results: Subjects wearing active nasal ﬁlters had signiﬁcantly reduced scores, atall time-points compared with placebo group (all P < 0.05). Of 14 individualsymptoms measured, seven were signiﬁcantly reduced (number of sneezes, runnynose, itchy nose, sniﬄes, itchy throat; itchy eyes and watery eyes) and anotherthree showed a trend towards lower severity. The nasal ﬁlters also enabled the Key words: allergen avoidance; nose filter; prevention.
resolution of existing symptoms. Maximal diﬀerence in symptoms was seenimmediately after subjects had spent 20 min sitting beside a large patch of Conclusion: This is the ﬁrst clinical trial of a nasal ﬁlter. The results suggest it has potential for enhancing rhinitis management during acute allergen Avoidance of allergens is advocated as the ﬁrst step in management of allergic rhinitis, and as an adjunct to medications (1, 2). It is recognized, however, thatavoidance of pollens and fungal spores is diﬃcult to The nasal ﬁlter is shown in Fig. 1. The airﬂow resistance and cap- achieve because of their ubiquitous nature (1). Facemasks ture eﬃciencies for ragweed (Ambrosia artemisiifolia), Bermuda provide personal protection; however, they are only used grass (Cynadon dactylon) and Bahia grass (Paspalum notatum) by 1% of people (3). While the mainstay of rhinitis pollen (Greer Laboratories Inc., Lenoir, NC) were measured at ﬂowrates of 4.6, 10.3, 21.7 and 32.5 l/min as previously described (4).
management is pharmacotherapy, 74% of people reportthat medications do not adequately control their symp-toms, and 65% report avoiding some medications The study utilized a double-blind placebo-controlled design. The We have previously described nasal ﬁlters, worn inside study was approved by the Human Ethics Committee of Northern the nose that collect inhaled particles using the principle Rivers Area Health Service, and subjects gave written informed of impaction (4). They are easy to breathe through, and consent. Eligible subjects were over 16 years old, had a history of have a high capture eﬃciency for particles above 8 lm in rhinitis exacerbation in the autumn and were skin prick test-positive diameter (4), which includes all pollens (5). Given the to mixed ragweed, Bermuda grass and/or Bahia grass (Table 1).
prevalence of allergic rhinitis, the level of dissatisfaction Exclusion criteria were: complete nasal obstruction, recent sinusitis,history of severe asthma exacerbations, or use of nasal steroids/ with current medications and lack of acceptance of an antihistamines/systemic decongestants within the last month. The eﬀective method to prevent exposure outdoors, we tested study location was a semirural park with abundant ﬂowering Bahia a prototype nasal ﬁlter to determine if it would reduce and Bermuda grasses and ragweed. Prior to arriving at the park symptoms of allergic rhinitis during high natural expo- subjects wore disposable dust-masks to reduce the development of baseline symptoms. Subjects were randomly allocated to one of Self-assessed rhinitis symptoms and peak nasal inspiratory ﬂowwere recorded at baseline and at 30 min intervals during thechallenge. Self-recorded symptoms were combined into twocomposite variables: Major Symptom Complex (MSC) and TotalSymptom Complex (TSC) severity scores (6–8). To ensure that atleast moderate levels of ragweed pollen exposure were experi-enced by all participants, each group sat beside a large patch ofragweed for 20 min, during the period 30–60 min after ﬁlterinsertion.
Ambient pollen levels were measured using a Burkard 7-day volu-metric spore trap, running at 10 l/min, located 3.5 m above theground at the challenge site. Individual pollen exposures weremeasured by the number of pollen grains collected on the adhesivecore of the active nasal ﬁlters. Samples were stained with Calberla’s Figure 1. The nasal ﬁlter prototype is made up of a soft medical solution (9) and ragweed and grass pollen were counted under a grade silicone and has an inner polypropylene core is coated with an adhesive. The placebo ﬁlters were of identical externalappearance, but did not have an inner core (inner core has been removed from only one nostril in this picture). To accommodatediﬀerent sized noses, two sizes of nasal ﬁlter were used.
In a questionnaire administered 1 week after the challenge, sub-jects were asked to score their global satisfaction with the nasalﬁlters.
Table 1. Baseline subject characteristics The primary outcome variables were change in MSC and TSC scores from baseline, using all time-points. Secondary outcome variables were changes from baseline in the individual components of MSC and TSC. Overall diﬀerences between groups were exam- Duration of allergic rhinitis, years (range) ined by repeated measures anova, and t-tests were used to analyse diﬀerences between treatment groups at each time-point. Diﬀer- ences between groups in the frequency of sensitization were exam- ined by chi-squared test. Statistical signiﬁcance was deﬁned as In the test rig, pollen capture for Bahia, Bermuda and MSC, Major Symptom Complex, range 0–1360 (number of nose blows, number of ragweed averaged 98% for active and 3.5% for placebo sneezes, runny nose, sniffles, itchy nose and watery eyes); TSC, Total Symptom ﬁlters, across the range of ﬂow rates. Airﬂow resistance, Complex, range 0–2448 (MSC symptoms plus itchy eyes, itchy ears, itchy throat, cough and postnasal drip); SPT-positive ¼ skin prick test weal ‡4 mm2.
* ¼ P < 0.05 between active and placebo groups.
2O/L/s for active and 1.6 cmH2O/L/s for placebo Pollen exposure on the challenge day was measured at 102 grains/2 h from the spore trap, and 68 pollen grains/ eight groups, and each group received either active (n ¼ 22) or person/2 h from the active ﬁlters (geometric mean placebo (n ¼ 24) nasal ﬁlters (Fig. 1). To eliminate visual unblind-ing: neither participants nor group supervisors (medical students) had previous experience of the nasal ﬁlters; the way the ﬁltersworked was not explained to the participants or supervisors; supervisors were blinded to the randomization allocation; withineach group all subjects received the same type of ﬁlter; there was no Baseline MSC scores, prior to ﬁlter insertion, were 339.8 contact between groups; and the external appearance of the active and 187.3 for the active (n ¼ 22) and placebo (n ¼ 24) and placebo ﬁlters, once inserted, was identical.
After baseline assessments, subjects removed the dust-masks ﬁlter groups, respectively (P ¼ 0.02). Over the 2-h chal- and placed the nasal ﬁlters into their nostrils. Subjects were asked lenge period MSC decreased in the active group and to breathe through the nose for 2 h, while engaging in only mild increased in the placebo group compared with baseline activity (sitting, walking, eating) in a central location in the park.
(Fig. 2), resulting in highly signiﬁcant diﬀerences between Nasal ﬁlters for ragweed and grass pollen Time (min)
Figure 2. Mean absolute change in MSC scores between active and placebo nasal ﬁlter groups. Overall diﬀerence between act-ive and placebo P ¼ 0.0076, repeated measures anova. Error bars are 95% conﬁdence intervals (CIs) for each mean.
#P < 0.001, *P < 0.05 (t-test). MSC ¼ Major Symptom Complex (number of nose blows, number of sneezes, runny nose, sniﬄes, itchy nose and watery eyes).
–70 –60 –50 –40 –30 –20 –10
Figure 3. Percentage change from baseline in each symptom the groups (overall, P ¼ 0.0076). At 30, 60, 90 and score for active and placebo ﬁlter groups at 60 min. *P < 0.05 120 min the net diﬀerence in MSC for active compared at 60 min (t-test). Individual symptoms that were signiﬁcantly with placebo ﬁlters were )25, )68, )39 and )50% points reduced by the ﬁlters during the 2 h study were: number of respectively. The maximum diﬀerence was seen at 60 min, sneezes, runny nose, itchy nose, sniﬄes, itchy throat, itchy eyes immediately after the 20 min period of sitting beside a large patch of ragweed. Similar diﬀerences between activeand placebo ﬁlters were seen in TSC scores (data notshown, overall P ¼ 0.023).
For seven of the 14 individual symptoms, there was a signiﬁcant reduction in severity and for a further three This is the ﬁrst reported clinical trial of nasal ﬁlters for symptoms there was a consistent trend towards lower the prevention of symptoms of allergic rhinitis. The nasal severity in the active ﬁlter group than the placebo group.
ﬁlters collect inhaled particles by impaction (4), resulting The strongest eﬀect was seen for the symptoms of sniﬄes in high capture eﬃciency for particles above 8 lm and (overall, P ¼ 0.004), rhinorrhea (overall, P ¼ 0.035) and negligible air-ﬂow resistance (4, 10). Most pollen grains itchy nose (overall, P ¼ 0.034), especially at 60 min are above 15 lm in diameter and ragweed, Bermuda and (Fig. 3) where highly signiﬁcant diﬀerences were found.
Bahia pollens which are 18, 28 and 34 lm, respectively During the 2-h challenge period, signiﬁcant reductions (5) were captured with high eﬃciency in the nasal ﬁlter were also observed in number of sneezes, itchy throat, itchy eyes and watery eyes (P < 0.05, t-test). For number In the clinical trial of natural outdoor pollen exposure, of nose blows, nasal blockage and peak nasal inspiratory the net diﬀerence in MSC scores were the result of ﬂow, there was a trend to improvement in the active decreases in symptoms in the active ﬁlter group ()18 to group but the diﬀerences were not signiﬁcant. The active )33%) and increases in symptoms in the placebo ﬁlter ﬁlters did not appear to inﬂuence postnasal drip or cough, group (+7 to +35%), with a maximum net diﬀerence in while a signiﬁcant (P < 0.05) increase in itchy ears was MSC of 68% at 60 min. While this study did not compare the eﬃcacy of the ﬁlters to rhinitis medications, a surveyof the literature indicates that both the magnitude andonset of symptom reduction with active ﬁlters compares very favourably with that from medications (6–8, 11). The Ninety-three percent of subjects said they would be rapid reduction of pre-existing symptoms in the active prepared to wear the ﬁlters again, with most people ﬁlter group may expand the utility of the ﬁlters. In studies prepared to use them in private situations such as around of rhinitis medications, which have used similar acute the house (88%) or in the garden (81%) compared with challenge experiments, there has been a well-recognized visiting friends (46%) or playing golf (33%).
placebo eﬀect (6–8), which was not observed for the placebo ﬁlter group, although the low baseline symptoms (12). Conventional allergen avoidance strategies such as may account for this. Of note is the beneﬁcial eﬀect of the mattress encasing, when practiced with high allergen load nasal ﬁlters on ocular symptoms (Fig. 3), which is in a normal domestic setting, often appear to fail to consistent with the converse observations of ocular reduce allergens to a level where signiﬁcant improvement symptoms occurring following direct nasal challenge (1).
in symptoms occur [see meta-analysis (13)]. Additional Although the active nasal ﬁlter group had signiﬁcantly studies are required to examine the feasibility of using the higher baseline symptoms than the placebo group, this nasal ﬁlters for longer periods, as would be needed for did not explain the signiﬁcant reduction in symptoms in the active group. A post hoc analysis of data forindividuals with similar mid-range baseline symptoms inboth groups (n ¼ 10/group) showed a signiﬁcant reduc- tion in MSC and TSC for the active ﬁlter group ()35%),while symptoms in the placebo group increased by Authors thank Prof. John Beard, Northern Rivers University, approximately 28% (P < 0.05). The active and placebo Department of Rural Health, University of Sydney and Mr Mark groups also diﬀered in the prevalence of sensitization to Barlettt, Northern Rivers Area Health Service, for their assistance Bermuda grass (Table 1); however, this was not related in setting up this project. Drs Janet Rimmer, Connie Katelaris andNorbert Berend reviewed the trial protocol. Authors appreciate the to baseline MSC scores (P ¼ 0.89, t-test).
support provided by the NSW Department of State and Regional The nasal ﬁlters may also have an application for the Development and Inhalix Pty Ltd. The authors also thank Kath prevention of exposure to perennial allergens, especially O’Driscoll for assistance with recruiting and running the trial and those from house dust mites where the majority of Dr Diana Bass for help with location of a suitable site. Thank you allergen is carried on particles above 10 lm in diameter to all the subjects who volunteered for this study.
port: allergic rhinitis and its impact on airway resistance loads in older adults.
and safety of cetirizine, loratadine, and placebo for seasonal allergic rhinitis.
7. Day J, Briscoe M, Wilditz M. Cetirizine, Selner J. Allergic rhinitis: the patient’s seasonal allergic rhinitis: effects after 13. Gotzsche P, Hammarquist C, Burr M.
management of asthma: meta-analysis.
MK. Recognition of pollen and otherparticulate aeroantigens by immunoblotmicroscopy. J Allergy Clin Immunol1988;82:608–616.
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