NOSK NASAL FILTER HEALTH TECHNOLOGY ASSESSMENT SECTION MEDICAL DEVELOPMENT DIVISION MINISTRY OF HEALTH MALAYSIA 014/2013

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1 NOSK NASAL FILTER HEALTH TECHNOLOGY ASSESSMENT SECTION MEDICAL DEVELOPMENT DIVISION MINISTRY OF HEALTH MALAYSIA 1 014/2013

2 DISCLAIMER Technology review is a brief report, prepared on an urgent basis, which draws on restricted reviews from analysis of pertinent literature, on expert opinion and / or regulatory status where appropriate. It has not been subjected to an external review process. While effort has been made to do so, this document may not fully reflect all scientific research available. Additionally, other relevant scientific findings may have been reported since completion of this review. Please contact: htamalaysia@moh.gov.my, if you would like further information. Health Technology Assessment Section (MaHTAS), Medical Development Division Ministry of Health Malaysia Level 4, Block E1, Precinct 1 Government Office Complex Putrajaya Tel: Fax: Available at the following website: i

3 Prepared by: Dr Khadijah binti Abdul Rahim Senior Assistant Director Health Technology Assessment Section (MaHTAS) Ministry of Health Malaysia Reviewed by: Datin Dr Rugayah Bakri Deputy Director Health Technology Assessment Section (MaHTAS) Ministry of Health Malaysia DISCLOSURE The author of this report has no competing interest in this subject and the preparation of this report is totally funded by the Ministry of Health, Malaysia. ii

4 EXECUTIVE SUMMARY Introduction Eating behaviours and respiratory problems are among the many causes of global health problems that we face today. With regards to respiratory problems, we are exposed every day to the air that has potentially been polluted with chemicals, dirt including dust particles and allergens, and germs of many kinds. Nasal filter is a new device, about the size of a contact lens that is worn in the nose and claimed to work like a miniature air filter. It is said that it may help filter out pollen and other allergens and keep them out of the sinuses. While the Rhinix nasal filter is still under study and not yet out for sale, several other brands of nasal filters have emerged in the market. In Malaysia, the Nosk nasal filter was brought in by the Lisse company since February In view of the rampant occurrence of respiratory problems among pilgrims, the potential of using Nosk as a mean of protection is being considered. Thus, this technology review was requested by the Malaysian Institute of Research on Health Behaviour (Institut Penyelidikan Tingkahlaku Kesihatan). Objective/ aim The objective of this systematic review is to assess the efficacy/ effectiveness, safety, and cost-effectiveness of the Nosk nasal filter for prevention of respiratory problems (such as respiratory disease/ respiratory infection) specifically among pilgrims. Results and conclusions There was no retrievable evidence on the efficacy/ effectiveness of the Nosk nasal filter for prevention of respiratory problems among pilgrims. Nevertheless, there was limited good level but of fair quality evidence available to suggest the effectiveness of nasal filters of other brands in reducing symptoms and improving quality of life of patients with allergic rhinitis. However, the evidence was insufficient in numbers and the sample size in each study was small. Apart from allergic rhinitis, there was no retrievable evidence on the effectiveness of the nasal filters for prevention of other respiratory diseases. The Nosk nasal filter is claimed to have United States Food and Drug Administration (US FDA) approval and approval from Korea Institute of Health and Technology. There was limited evidence to suggest that nasal filters is safe and is associated with only mild adverse events. There was also no study found on the cost-effectiveness of nasal filters. Methods Literatures were searched through electronic databases specifically Ovid, PubMed, Embase, Medline and Cochrane. Information was also retrieved from USFDA and Google Scholar. Cross-referencing of the articles retrieved was also carried out accordingly. Relevant articles were critically appraised and evidence graded using the US Canadian Preventive Services Task Force. iii

5 NOSK NASAL FILTER 1. INTRODUCTION Eating behaviours and respiratory problems are among the many causes of global health problems that we face today. In terms of eating habit, various types of dietary modifications and recommendations are available depending on the health problems faced. With regard to respiratory problems, we are exposed every day to the air that has potentially been polluted with chemicals, dirt including dust particles and allergens, and germs of many kinds. 1 Nasal filter is a new device, about the size of a contact lens that is worn in the nose and claimed to work like a miniature air filter. It is said that it can help filter out pollen and other allergens and keep them out of the sinuses. 2 Nasal filters are said to be a practical and comfortable alternative for face mask. 1 While the Rhinix nasal filter is still under study and not out for sale yet, several other brands of nasal filters have emerged in the market. The Nosk nasal filter is designed and manufactured in South Korea in It is made available in the Europe and US since In Malaysia, Nosk was brought in by the Lisse company since February In view of the rampant occurrence of respiratory problems among pilgrims performing hajj and umrah, the potential of using Nosk as a mean of protection is being considered. Thus, the technology review on the Nosk nasal filter was requested by the Malaysian Institute of Research on Health Behaviour (Institut Penyelidikan Tingkahlaku Kesihatan). 2. OBJECTIVE / AIM The objective of this systematic review is to assess the efficacy/ effectiveness, safety, and cost-effectiveness of the Nosk nasal filter for prevention of respiratory problems (such as respiratory disease/ respiratory infection) specifically among pilgrims. 3. TECHNICAL FEATURES What is Nosk? Nosk is a personal air filtration system that consists of twin soft nasal filters held together by a thin translucent plastic strip. It is made of sterile medical-grade materials; the twin filter membranes are crafted from a three-layered Spunbond-Meltblown-Spunbond (SMS) microfibers while the 1

6 plastic strip that holds Nosk in place is made of soft and pliable non-toxic Polyolefin Elastomer (POE) and is virtually invisible. Nosk is drug free and its use is claimed to reduce the inhalation of pollutants and allergens by 80%. After being worn up to eight to twelve consecutive hours, the Nosk nasal filter needs to be washed and rinsed off gently with clean water. It is reusable up to maximum five to eight times of washing How Nosk works The mechanism by which the Nosk nasal filter functions is via filtration. The triple layered SMS microfibers that made up the Nosk s twin membranes filter out minute particles which include microscopic dust particles, pollen and chemicals during breathing. It is claimed that laboratory tests done in Korea has proven that the Nosk air filtration system is able to provide 100% filtration of particles sized 1 micrometer and above and 80% or more filtration of particles sized 0.2 micrometer and above. 2

7 3.2. How to use Nosk To start using Nosk, the device is inserted into the nasal cavities. The user then needs to inhale to set the filter in place. Upon exhalation, the filter will contract to allow air to flow out. To remove the device, it is gently slid out of the nasal cavities. 4. METHODS 4.1. Searching Electronic databases were searched through the Ovid interface: Ovid MEDLINE In-process and other Non-indexed citations and Ovid MEDLINE 1946 to present, EBM Reviews - Cochrane Central Register of Controlled Trials July 2014, EBM Reviews - Cochrane Database of Systematic Reviews to July 2014, EBM Reviews - Health Technology Assessment - 3 rd Quarter 2014, EBM Reviews - Database of Abstracts of Reviews of Effects - 3 rd Quarter 2014, EBM Reviews NHS Economic Evaluation Database 3 rd Quarter 2014, Embase 1988 to 2014 week 32. Searches were also run in PubMed. Google was used to search for additional web-based materials and information. Additional articles were identified from reviewing the references of retrieved articles. Appendix 1 showed the detailed search strategies Selection A reviewer screened the titles and abstracts against the inclusion and exclusion criteria and then evaluated the selected full text articles for final article selection. 3

8 The inclusion and exclusion criteria were: Inclusion criteria Problems i. Pilgrims ii. Patients with breathing problems/ respiratory infections/ respiratory diseases Interventions Nosk nasal filter Nasal filter Comparators Face mask No nasal filter Outcomes i. Reduced breathing problems/ respiratory infections/ respiratory diseases ii. Safety iii. Effectiveness iv. Cost-effectiveness Study design Health Technology Assessment (HTA), Systematic Review, Randomised Controlled Trial (RCT), Non Randomised Controlled Trial, Cohort studies, Case Control studies, Cross sectional studies, case series, case reports English full text articles Exclusion criteria Study design Studies conducted in animals and narrative reviews Non English full text articles Relevant articles were critically appraised using Critical Appraisal Skills Programme (CASP) and graded according to US/ Canadian Preventive Services Task Force (Appendix 2).. 5. RESULTS AND DISCUSSION A total of twenty titles were identified through the Ovid interface and PubMed. Three articles related to nasal filters were included in this review: two randomised controlled trial and one non-randomised clinical trial. Although no evidence on the Nosk nasal filters was available, articles reviewed were clinical research done on similar technology. 4

9 5.1. EFFECTIVENESS Kenney P et al. conducted a randomised controlled trial which studied the use of Rhinix nasal filters for the treatment of allergic rhinitis (AR). The Rhinix nasal filter consists of a membrane that removes particles by means of interception and impaction. The material, by which the membrane was made of, was not stated. The study involved 24 adults from which three were excluded due to the unintended consequence of having the devices to come into continuous contact with the mucosal membrane; one subject was excluded because of a septal deviation that went unnoticed during screening, whereas the other two were excluded because their nasal cavities proved too small for the sizes of nasal filters available, resulting in only 21 subjects eligible for analysis. All subjects received both placebo and actual treatment blinded in randomised order in a cross-over manner. In the placebo filters, the membrane was omitted from the filter frame. All subjects had history of grass pollen-induced AR confirmed based on positive specific IgE levels and a positive skin prick test response to the Phleum pratense pollen. Subjects were exposed to grass pollen in an environmental exposure unit (EEU) for 210 minutes and rated their symptoms at baseline (time=0), every 30 minutes in the EEU until 180 minutes, shortly after exiting the EEU (approximately at 220 minutes) and three hours later (at 390 minutes). The EEU was a 4.15m x2.9m x 2.7m stainless steel room evenly dispersed with the P pratense pollen. Study subjects, care providers, EEU technicians and study investigators were blinded to the allocations. Apart from that, the same operator handled the insertion and removal of the devices for all subjects. Assessment were made using a total nasal symptom score (TNSS) consisting of nasal congestion, nasal discharge, nasal itching and sneezing. The primary outcome measure was the difference between the active and placebo groups in the maximum TNSS. The study found that the difference in daily TNSS was significantly reduced for Rhinix when compared with placebo (P=0.049) with mean and median reductions of 21% and 24%, respectively; the individual symptom of sneezing was reduced by 45% (P=0.011). Besides the symptoms in the TNSS, several other related symptoms were also evaluated. Throat irritation was proven to decrease significantly with Rhinix versus placebo at 220 minutes (P=0.037), with a mean reduction of 75%. Overall, analyses at each time point between Rhinix and placebo became significant or tended to become significant towards the end of the exposure period. The authors concluded that statistically significant and clinically relevant reductions were achieved with Rhinix nasal filters in daily TNSS as well as in a subset of individual symptoms for patients with seasonal AR. Therefore, Rhinix appears useful in the treatment of seasonal AR, although in-season studies on efficacy and usability (particularly concerning convenience, comfort and treatment costs) in larger populations are needed to verify 3, level I this. 5

10 Similarly, O Meara TJ et al. carried out a randomised controlled trial involving 46 subjects, looking at the effect of using prototype nasal filters in reducing rhinitis symptoms during natural exposure of subjects to ragweed and grass pollen. The study was conducted in a park with ragweed, Bermuda and Bahia grass where the study subjects wore nasal filters for two hours. Twenty two of the subjects received active nasal filters whilst another 24 received placebo ones. The nasal filter prototype (active nasal filter) was made up of soft medical grade silicone and had an inner polypropylene core coated with an adhesive, whereas the placebo filters were of identical external appearance but did not have an inner core. For blinding, supervisors were blinded to the randomisation allocation, neither participants nor supervisors had previous experience of the nasal filters, the way the filters worked was not explained to the participants or supervisors, within each group all subjects received the same type of filter, there was no contact between groups, and the external appearance of the active and placebo filters, once inserted, was identical. All subjects had history of autumn exacerbation of rhinitis and positive skin prick test to ragweed, Bermuda and/ or Bahia grass. Major and total symptom scores were recorded at 0, 30, 60, 90 and 120 minutes. The primary outcome variables were changes in Major Symptom Complex (MSC) and Total Symptom Complex (TSC) from baseline, using all time points. Secondary outcome variables were changes from baseline in the individual components of MSC and TSC. The components in MSC were number of nose blows, number of sneezes, runny nose, sniffles, itchy nose and watery eyes, whereas TSC consisted of MSC symptoms plus itchy eyes, itchy ears, itchy throat, blocked nose, cough, peak nasal inspiratory flow and postnasal drip. The results of the study showed that over the two hours challenge period, MSC decreased in the active group and increased in the placebo group, resulting in highly significant differences between the groups (P=0.0076). Similar differences were seen in TSC scores (P=0.0023). As for the individual components of the scores, symptoms that showed strongest significant effect were sniffles (P=0.004), rhinorrhea (P=0.0035) and itchy nose (P=0.0034). Other symptoms that showed significant reductions were number of sneezes, itchy throat, itchy eyes and watery eyes. For number of nose blows, nasal blockage and peak nasal inspiratory flow, there was a trend towards improvement in the 4, level I active groups but the differences were not significant. In a non- randomised clinical trial by D Amato G et al., 15 patients with allergic rhinoconjunctivitis volunteered to be involved, of which only 13 completed the study as the other two were unable to wear the nasal filters comfortably. The trial was a preliminary study looking at improvement of quality of life in allergic rhinoconjunctivitis patients using the Sanispira nasal filters. No blinding was mentioned in this study. The concept of filtering by Sanispira was by attracting the particles present in the air and trapping them irreversibly via the viscous coating of its biocompatible 6

11 material which composed the nasal part of the device. Each patient was assessed by the rhinoconjunctivitis quality of life questionnaire (RQLQ) at three different time points: at baseline, after seven days of Sanispira use, and after 18 days of Sanispira use. The RQLQ was composed of specific questions designed to measure the functional problems, namely physical, emotional, social and occupational, that are most troublesome to adults. Results of the study showed improvement though not significant in total RQLQ scores at one week of Sanispira use, and significant improvement after 18 days of use with P= The principal significant improvement were in the nasal symptoms domain between baseline and 18 days in particular stuffy nose (P=0.047), runny nose (P=0.012) and sneezing (P=0.0021) whereas in the domain of practical problems, the need to repeatedly blow the nose showed improvement with P= Aside from the RQLQ, subjects were also assessed by the symptoms form which looked at other related symptoms, and the drugs form that evaluated the use of antiallergic drugs in the last week. For the related symptoms, there was significant improvement (P=0.049) in ocular symptoms (foreign body sensation, or redness, or itching). As for the usage of antiallergic drugs, though there was no significant improvement, the result showed a trend to diminish the consumption of drugs, with three of the thirteen (23%) patients completely eliminated the use of drugs at the end of the study. The authors concluded that their results were in line and follow statistically with those of D Amato and O Meara, and patients had a great 5, level II-I improvement in their nasal symptoms thus in their quality of life. Apart from the effectiveness of using nasal filters in allergic rhinitis patients, no other evidence was retrievable on the effect of nasal filters in other medical conditions SAFETY The Nosk nasal filter is claimed to be approved by United States Food and Drug Administration (US FDA) and has a CE mark. In the study by Kenney P et al., they reported that three subjects experienced mild treatmentrelated adverse events of unspecified nasal irritation. No other treatmentrelated adverse events were reported. According to the study, most subjects quickly stopped noticing that they were wearing the device, and no difference in increased breathing resistance could be detected between actual treatment and placebo. Nineteen out of 21 (90.5%) subjects in the study were interested in using the device and all subjects felt completely safe with the Rhinix nasal filters. 3 Similarly, in the clinical trial by O Meara TJ et al., 93% of subjects said they would be prepared to use the filters again. 4 7

12 5.3. COST / COST-EFFECTIVENESS There was no evidence retrievable on the cost-effectiveness of this technology. However, from the information on the price of Nosk obtained from the Lisse company, the Nosk nasal filters are sold in boxes of five pads of nasal filters per box where each pad consists of two nasal filters. One pad (two pieces) of nasal filters costs RM20 whereas one box (five pads i.e. ten nasal filters) costs RM LIMITATIONS This technology review has several limitations. The selection of studies was done by one reviewer. Although there was no restriction in language during the search but only English full text articles were included in this report. Any abstracts without full text articles were also excluded. The clinical trials included in this review were of small sample size. 8

13 6. CONCLUSION There was no retrievable evidence on the efficacy/ effectiveness of the Nosk nasal filter for prevention of respiratory problems among pilgrims. Nevertheless, there was limited good level but of fair quality evidence available to suggest the effectiveness of nasal filters of other brands in reducing symptoms and improving quality of life of patients with allergic rhinitis. However, the evidence was insufficient in numbers and the sample size in each study was small. Apart from allergic rhinitis, there was no retrievable evidence on the effectiveness of the nasal filters for prevention of other respiratory diseases. The Nosk nasal filter is claimed to have FDA approval and approval from Korea Institute of Health and Technology. There was limited evidence to suggest that nasal filters is safe and is associated with only mild adverse events. There was also no study found on the cost-effectiveness of nasal filters. In general, more studies involving larger populations and over longer periods of time are required to establish the feasibility of using nasal filters. Specifically, clinical research on the Nosk nasal filter is warranted to provide quality evidence to support the recommendation of its use among pilgrims. 9

14 7. REFERENCES 1. Nosk product detailed information. Lisse Enterprise Gordon S. Could Nasal Filter Device Help Ease Allergies? Available at Accessed on 07/07/ Kenney P, Hilberg O, Pedersen H et al. Nasal filters for the treatment of allergic rhinitis: A randomized, double-blind, placebo-controlled crossover clinical trial. J Allergy Clin Immunol.2014;133(5): O Meara TJ, Sercombe JK, Morgan G et al. The reduction of rhinitis symptoms by nasal filters during natural exposure to ragweed and grass pollen. Allergy.2005;60: D Amato G, Rumi G, Cantera E et al. Improvement of quality of life in allergic rhinoconjunctivitis patients using nasal filters, a preliminary study. Eur Ann Allergy Clin Immunol.2013;45(5):

15 8. APPENDIX 8.1. Appendix 1: LITERATURE SEARCH STRATEGY Ovid MEDLINE In-process & other Non-Indexed citations and OvidMEDLINE 1946 to present 1. pilgrim*.tw. (759) 2 RESPIRATION DISORDERS/ (5983) 3 (respiration adj1 disorder*).tw. (76) 4 RESPIRATORY TRACT DISEASES/ (18834) 5 (respiratory tract adj1 disease*).tw. (2309) 6 (tract disease* adj respiratory).tw. (5) 7 RESPIRATORY TRACT INFECTIONS/ (31621) 8 (infection* adj1 (upper respiratory tract or upper respiratory or respiratory tract or respiratory)).tw. (15663) 9 respiratory infection upper.tw. (2) 10 breathing problem*.tw. (332) 11 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 (66633) 12 NOSE/ (18377) 13 nose*.tw. (30656) 14 (external adj1 nose*).tw. (237) or 13 or 14 (44015) 16 FILTRATION/ (20189) 17 filtration*.tw. (92215) 18 filter.tw. (53851) or 17 or 18 (152215) and 19 (200) 21 nasal filter.tw. (14) or 21 (203) 23 1 and 22 (0) and 22 (6) 11

16 OTHER DATABASES EBM Reviews - Cochrane Central Register of Controlled Trials EBM Reviews - Cochrane Database of Systematic Reviews EBM Reviews - Health Technology Assessment EBM Reviews - Database of Abstracts of Reviews of Effects EBM Reviews NHS Economic Evaluation Database EMBASE Same MeSH, keywords, limits used as per MEDLINE search PubMed (((((((((((((((((((((((((respiration disorders[mesh Terms]) OR respiratory tract diseases[mesh Terms]) OR respiratory tract infections[mesh Terms]) OR respiration[mesh Terms]) OR respiration disorder*[title/abstract]) OR disorder* respiration[title/abstract]) OR disease* respiratory tract[title/abstract]) OR respiratory tract disease*[title/abstract]) OR tract disease* respiratory[title/abstract]) OR upper respiratory tract infection*[title/abstract]) OR infection* upper respiratory tract[title/abstract]) OR infection* upper respiratory[title/abstract]) OR upper respiratory infection*[title/abstract]) OR respiratory tract infection*[title/abstract]) OR infection* respiratory tract[title/abstract]) OR infection* respiratory[title/abstract]) OR respiratory infection*[title/abstract]) OR respiratory infection* upper[title/abstract]) OR breathing problem*[title/abstract])) AND ((nasal filter*[title/abstract]) OR ((((((nose[mesh Terms]) OR nose*[title/abstract]) OR external nose*[title/abstract]) OR nose* external[title/abstract])) AND (((filtration[mesh Terms]) OR filtration*[title/abstract]) OR filter*[title/abstract]))) 12

17 8.2. Appendix 2 DESIGNATION OF LEVELS OF EVIDENCE I Evidence obtained from at least one properly designed randomized controlled trial. II-I Evidence obtained from well-designed controlled trials without randomization. II-2 II-3 III Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or research group. Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence. Opinions or respected authorities, based on clinical experience; descriptive studies and case reports; or reports of expert committees. SOURCE: US/ CANADIAN PREVENTIVE SERVICES TASK FORCE (Harris 2001) 13

18 Evidence Table: Effectiveness Question: How effective is wearing nasal filter compared with no nasal filter? Appendix 3 Bibliographic citation 1. Kenney P, Hilberg O, Pedersen H et al. Nasal filters for the treatment of allergic rhinitis: A randomized, double-blind, placebocontrolled crossover clinical trial. J Allergy Clin Immunol.2014;13 3(5): Study type and Methodology Randomised controlled trial LE I Num. of pts and Pt characteristics - 24 patients: 11 female,13 male - Age 18-65y, mean - Positive history of SAR for a minimum of 2y before study entry documented by a positive skin prick test to P pretense within 12mo of study entry - Specific IgE for timothy grass pollen Reliable method of birth ctrl for fertile women Intervention Length of f/u Outcome measures General comments - Rhinix nasal filter vs Primary outcome Small sample placebo Maximum TNSS, P=0.14 size - Device insertion done by Daily TNSS, P=0.049 same operator for all Out-of-season participants using Exploratory analyses: setting standardized method - Conducted at an EEU dispersed with Phleum pretense pollen 390 minutes Subjects were assessed at baseline (time=0), every 30min in the EEU, shortly after exiting the EEU (at approx. 220min) and 3hrs later (at 390min) Individual nasal symptoms Itching Max, P=0.004 Daily, P=0.234 Runny nose Max, P=0.706 Daily, P=0.174 Sneezing Max, P=0.006 Daily, P=0.011 Blocked nose Max, P=0.928 Daily, P=0.702 Ocular symptoms (TOSS): Max, P=0.35 Daily, P=0.59 Throat irritation, P=0.037 at 220min Intranasal volume, P=0.85 at 220min 14

19 Bibliographic citation 2. O Meara TJ, Sercombe JK, Morgan G et al. The reduction of rhinitis symptoms by nasal filters during natural exposure to ragweed and grass pollen. Allergy.2005;60: Study type and Methodology Randomised controlled trial LE I Num. of pts and Pt characteristics - 46 subjects, all female - Age 17 to 75 yo - Positive history of autumn exacerbation of rhinitis and positive skin prick test to ragweed, Bermuda and/ or Bahia grass Intervention Length of f/u Outcome measures General comments - prototype nasal filter vs 120 minutes Primary outcome Small sample placebo Subjects were Change in MSC and TSC size - Device insertion done by assessed at from baseline participants themselves baseline MSC, P= Conducted at semirural (time=0), 30, TSC, P=0.023 park with abundant 60, 90 and flowering Bahia and 120min Secondary outcome Bermuda grasses and Changes in baseline in the ragweed individual components of - subjects wore disposable MSC and TSC masks before arriving to park to reduce the Sniffles, P=0.004 development of baseline symptoms Runny nose, P=0.035 Itchy nose, P=

20 Bibliographic citation Study Type / Methodology LE Number of patients and patient characteristics Intervention Length of follow up (if applicable) Outcome measures/ Effect size General comments 3. D Amato G, Rumi G, Cantera E et al. Improvement of quality of life in allergic rhinoconjunctiviti s patients using nasal filters, a preliminary study. Eur Ann Allergy Clin Immunol.2013;45 (5): Non-randomised controlled trial II-I - 15 patients diagnosed with allergic rhinoconjunctivitis - 8 males, 7 females - patients had positive skin prick tests or specific IgE for different allergenic pollen grains or dermatophagoids - Sanispira nasal filters - 18days - patients assessed at baseline, day, 1 week after using Sanispira nasal filter and 18days after using Sanispira nasal filter improvement between baseline and 18 days in: - total RQLQ score P= stuffy nose, P= runny nose, P= sneezing, P= need to repeatedly blow nose, P= total score of symptoms, P= ocular symptoms, P= /13 (23%) patients eliminated use of drugs completely 16