Peak Nasal Inspiratory Flow Rate Research Articles

Relationship Between Rhinitis, Nasal Obstruction and Hypothyroidism: A Follow Up Study with Pre-post Treatment with Levothyroxine.

Hypothyroidism is the most common form of thyroid disorder in India, while, Rhinitis and Nasal obstruction are frequent complaints treated on regular basis in ENT OPD. Studies show that there is relationship between Rhinitis and Nasal obstruction with hypothyroidism. To assess the improvement in symptoms associated with Rhinitis and nasal obstruction in patients with hypothyroidism after treating with levothyroxine. 50 patients presenting in ENT OPD with rhinitis and nasal obstruction and diagnosed with hypothyroidism were selected. Complete history was taken and clinical examination was performed, Nasal Obstruction Symptom Evaluation Score, (NOSE) and Peak nasal inspiratory flow rate (PNIF) were noted. Biochemically proven hypothyroid patients were treated with adequate dosage of Levothyroxine. The patients were followed up and the above-mentioned tests were repeated at regular intervals (1month and 3month), Changes in these readings were recorded and maintained. Significant difference was found in TSH level, NOSE questionnaire, and PNIF reading in patients with hypothyroidism after treatment with levothyroxine (P value < 0.001). This was most commonly noted to occur in young and middle-aged population of age 15years to 50years (88%). In our study - An attempt was made to correlate the symptomatology with hypothyroidism. Treatment with levothyroxine in patients with rhinitis, nasal obstruction and biochemically proven hypothyroidism was found to be effective in improvement of symptoms. It was found that there is significant association between hypothyroid status and rhinitis with nasal obstruction.

Assessment of Nasal Smear Eosinophil Counts in Allergic Rhinitis: How Useful is it?

Objectives: The aim was to find the relationship between nasal smear eosinophil (NSE) counts and allergic rhinitis (AR) along with the impact of treatment on peak nasal inspiratory flow rates and symptom scores in these patients. Material and methods: An observational, comparative study was carried out with 75 patients of AR. Nasal smears were drawn and eosinophil counts were estimated. Nasal symptoms were assessed and compared by visual analogue scale (VAS) and peak nasal inspiratory flow (PNIF) rates before and after treatment. Equal number of healthy individuals formed the control group. Results: There was a strong association between increase in eosinophil count in nasal smears and AR (p = 0.000). A NSE count of 0.2/HPF had a specificity of 98.7%, sensitivity of 53.3%, and positive predictive value of 97.6% in the diagnosis of AR. The mean VAS scores for nasal obstruction improved from 7.35 to 1.01 and the mean peak nasal inspiratory flow from 69.00 L/min to 103.73 L/min (p < 0.0001) after treatment. The mean NSE counts reduced from 4.20/HPF to 0.090/HPF proving a strong correlation between improvement of symptom scores and NSE counts (p = 0.000) in AR. The study also determined that a PNIF value of ≤ 77.50 L/min can be used as a cut off for diagnosing nasal obstruction in these patients. Conclusion: A NSE count of ≥ 0.2 /HPF is to be considered as diagnostic of AR. Nasal congestion is the commonest symptom associated with AR and addition of systemic decongestant is required for management of these patients.

Improving Nasal Airflow with a Novel Nasal Breathing Stent.

Nasal obstruction requires close attention, as it is a risk factor for obstructive sleep apnea (OSA). This study evaluated airflow rates of our newly designed nasal breathing stent (NBS) compared with those of existing nasal dilators in 10 adult men. We hypothesized that the NBS would expand the nasal passage more than the other nasal dilators by means of airflow measurements. We compared airflow measurements between the NBS and three existing appliances and no appliance. Velocity measurements were recorded by analyzing 499 videographic images when each appliance was placed next to a steam generator at 0, 5, and 10 mm from the outlet port for airflow visualization. The peak nasal inspiratory flow (PNIF) rate was measured using an inspiratory flow meter. The NBS resulted in significantly higher airflow velocity measurements at all distances from the outlet port and a higher PNIF rate than the other appliances. Thus, the NBS offers a significantly decreased resistance to air movement compared with other appliances. Future in-depth investigations are required to demonstrate the use of NBS as a nasal dilator in conjunction with continuous positive airway pressure/oral appliance treatments in patients with OSA.

Investigation of Repeatability of Peak Nasal Inspiratory Flow Rate Measurements Under Baseline Conditions and After Administration of 0.05% Oxymetazoline.

Peak nasal inspiratory flow (PNIF) measurement is an inexpensive and user-friendly method to assess nasal patency. However, the repeatability of PNIF measurements, as well as the threshold value of a change in PNIF, which can be considered significant remain unclear. This study aims to investigate the repeatability of PNIF measurements and the change in PNIF after the administration of 0.05% oxymetazoline. Repeated measurements of PNIF (Clement Clarke In-Check nasal inspiratory flow meter; Clement Clarke International, Ltd, Harlow, Essex, UK) were obtained in 333 healthy volunteers (174 women). Based on age, participants were categorized into three groups (6-7 years, 13-14 years, and 20-45 years). We obtained five measurements in each participant. PNIF was remeasured in 294 subjects 30 min after administration of 0.05% oxymetazoline. The variability in PNIF measurements was assessed using the coefficient of variation (CV = standard deviation × 100%/mean). The first four PNIF measurements significantly differed from each other. The difference in PNIF measurements ceased to be statistically significant only between the fourth and fifth measurements (p = 0.19). PNIF repeatability was acceptable; the median CV was 15.5% (0-66), which did not significantly differ between age groups. The administration of 0.05% oxymetazoline led to a statistically significant increase in the PNIF value by 14.3% (-45, 157%) (p = 0.000000). 1. No statistically significant difference was observed in PNIF values only between the fourth and fifth measurements; therefore, at least three measurements are essential to draw meaningful conclusions. 2. PNIF measurements were satisfactorily characterized by a relatively low CV (15%). 3. The administration of 0.05% oxymetazoline led to an increase in PNIF by approximately 14% over the baseline value.

Reference Value of Nasal Peak Inspiratory Flow Rate in Indian Children: A Cross-sectional Study

Introduction: Peak Nasal Inspiratory Flow (PNIF) measurement is a basic, convenient, easy to use and low cost method of determining the nasal airway patency. However, normative data for paediatric population is scarce and not available for Indian children aged 6 to 12 years. Aim: To establish reference value of PNIF in Indian children aged 6 to 12 years of age. Materials and Methods: A descriptive cross-sectional study was conducted between July 2012 and June 2013 in the Himalayan range of east Sikkim district and Sub-Himalayan Terai region of Darjeeling district of West Bengal. Total 1001 children aged 6 to 12 years were selected from 16 schools by simple random sampling. Of these 1001 children, 784 children were enrolled in the study after taking into account inclusion and exclusion criteria. Repeated PNIF measurements were taken from these 784 children. Mean PNIF value was calculated. The effect of age and height on PNIF was studied. The mean and standard deviation of Peak Inhalation Flow Rate (PIFR) are calculated and compared across groups using a one-way ANOVA test. Regression analysis was done to establish an equation of predicting PNIF level based on height for normal children. The analysis was carried out using Statistical Package for Social Sciences (SPSS) version 16 statistical software. An alpha level of 5% was chosen, which means that any p-value less than 0.05 was considered significant. Results: Mean value of PNIF age group; 6-7 years-53.36 L/min, &gt;7-8 years-56.79 L/min, &gt;8-9 years-63.91 L/min, &gt;9-10 years- 69.45 L/min, &gt;10-11years- 80.71 L/min, &gt;11-12 years-85.69 L/ min. PNIF increases with age and height. A simple formula has also been established to calculate mean PNIF at a given height. PNIF or PIFR (L/min)=-52.716+0.945×height in cm. Conclusion: PNIF measurements are possible in children aged six years and older. Age and height also affect PNIF.

Assessment of Screening for Nasal Obstruction among Sleep Dentistry Outpatients with Obstructive Sleep Apnea.

Oral appliances (OA), a common treatment modality for obstructive sleep apnea (OSA), are not suitable for patients with nasal obstruction. Rhinomanometry, the gold standard technique to assess nasal airway resistance, is not readily available in sleep dentistry clinics. We demonstrate the use of a portable lightweight peak nasal inspiratory flow (PNIF) rate meter to objectively assess nasal airflow and utilized the Nasal Obstruction Symptom Evaluation (NOSE) scale to subjectively assess nasal obstruction in 97 patients with OSA and 105 healthy controls. We examined the correlations between the following variables between the groups: demographics, body mass index, PNIF, NOSE scale scores, apnea–hypopnea index (AHI), minimum SpO2 (SpO2min), Mallampati classification, and Epworth Sleepiness Scale (ESS) scores. Patients with OSA had significantly lower PNIF values and higher NOSE scores than controls. In the patient group, PNIF was not significantly correlated with AHI, SpO2min, Mallampati classification, or NOSE or ESS scores. Lower PNIF values and higher NOSE scores suggested impaired nasal airflow in the OSA group. As daytime PNIF measurement bears no relationship to AHI, this cannot be used alone in predicting the suitability of treatment for OSA with OA but can be used as an adjunct for making clinical decisions.

Rhinitis in patients with acquired hypothyroidism.

Our aim was to evaluate the rhinological changes during hypothyroid and euthyroid periods in patients with acquired hypothyroidism. The newly diagnosed 40 adult patients with hypothyroidism who presented to the Endocrinology clinic at a tertiary hospital were enrolled in the study. Patients having blood thyroid-stimulating hormone levels greater than 4.95IU/dl were consulted to the ENT clinic. Nasal Obstruction Symptom Evaluation scores, Peak Nasal Inspiratory Flow rates and nasalmucociliary clearancetime of patients were noted before and 4months after the oral levothyroxine sodium tablet treatment. Of the patients included in the study, 34 (85%) were females and 6 (15%) were males. The mean thyroid-stimulating hormone values before the treatment was 10.01 ± 3.31IU/dl and 4.03 ± 2.45IU/dl at the end of the treatment. The difference in values was statistically significant (p < 0.001). The mean mucociliary clearancetime before treatment was 8.03 ± 3.29min and 7.35 ± 2.87min at the end of treatment. The decrease in mucociliary clearancetime was statistically significant (p = 0.001). We did not detect any significant difference between pre- and posttreatment values of nasal obstruction symptom evaluation scores and peak nasal inspiratory flow rates. The patients with hypothyroidism have prolonged mucociliary clearance time in hypothyroid period of the disease. Regarding to this data, we may recommend clinicians to follow-up these patients more closely for respiratory tract diseases and sinonasal infections.

The Effect of Korean Red Ginseng on Symptoms and Inflammation in Patients With Allergic Rhinitis

Korean red ginseng (KRG) has been traditionally used in Korea for health improvement. However, the clinical effect of KRG intake on the symptoms in patients with allergic rhinitis remains unknown. Our study was performed to identify the clinical effects of KRG on patients with allergic rhinitis and to examine the effect of KRG on allergic inflammatory reaction. We evaluated 60 patients with allergic rhinitis. All the patients were treated for 4 weeks. The patients were divided into 3 groups, according to the medication. Twenty patients were treated with KRG, 20 patients with the placebo, and 20 patients with the antihistamine. The patients recorded their symptoms in a daily symptom diary card. The patients checked the peak nasal inspiratory flow rate 2 times a day. Total serum immunoglobulin E (IgE) and serum-specific IgE were measured by ImmunoCap method before and after 4-week medication. The Th2 cytokines interleukin-4 (IL-4), IL-5, and IL-10 were checked in the serum before and after the 4-week treatment. The eosinophil counts in the nasal smears were checked. Korean red ginseng group has shown the significant improvement in rhinorrhea, nasal itching, and eye itching. Both the antihistamine and KRG groups showed a significant decrease in total IgE level at the end of treatment. The serum IL-4 level and eosinophil counts in the nasal smears were significantly decreased both in the antihistamine and in the KRG groups. In conclusion, KRG might be a useful treatment modality for patients with allergic rhinitis.

Effect of misoprostol on patients with aspirin-exacerbated respiratory disease undergoing aspirin challenge and desensitization

BackgroundProstaglandin E2 (PGE2) is an anti-inflammatory compound that inhibits 5-lipoxygenase activity. Diminished PGE2 regulation in aspirin-exacerbated respiratory disease (AERD) leads to respiratory reactions on cyclooxygenase 1 inhibition. In vitro studies have found that exogenous PGE2 stabilizes inflammatory mediator release. ObjectiveTo examine whether misoprostol (oral prostaglandin E1 analogue) use during aspirin challenge and desensitization might decrease the severity of aspirin-induced symptoms and make desensitization safer for patients with AERD. MethodsForty-five patients undergoing aspirin challenge and/or desensitization were randomized to misoprostol (n = 30) or placebo (n = 15) and compared with a group of historical controls (n = 31). Misoprostol (200 μg) was administered at 30 minutes, 90 minutes, and 4 hours after the first dose of nasal ketorolac. Measured end points included change in forced expiratory volume in 1 second (FEV1), peak nasal inspiratory flow rate (PNIF), number of treatments received for induced reactions, and adverse gastrointestinal effects. ResultsA difference in FEV1 and PNIF reduction was detected between misoprostol and placebo (P = .03) and misoprostol and historical controls (P = .01), respectively, during nasal ketorolac challenge. No difference was detected among aspirin reactors. Among all reactors, no difference in magnitude was found for FEV1 (P = .13) or PNIF (P = .07) reduction across all 3 groups. Total treatment requirement was similar (P = .14). Patients receiving misoprostol were more likely to report adverse gastrointestinal effects (P = .02). ConclusionThe addition of misoprostol to current aspirin challenge and/or desensitization protocols reveals no protective effect in reducing the intensity of nonsteroidal anti-inflammatory drug–induced symptoms and is not recommended based on the findings in this study.

Efficacy and safety of once daily triamcinolone acetonide aqueous nasal spray in adults with non-allergic and allergic rhinitis

BackgroundThe efficacy of corticosteroid has not been thoroughly studied in the treatment of non-allergic rhinitis. This study was designed to compare the efficacy of nasal corticosteroid in patients with allergic rhinitis (AR), and non-allergic rhinitis (NAR). MethodsThe efficacy of triamcinolone acetonide nasal spray (TANS) on total nasal symptom scores (TNSS), and nasal peak inspiratory flow rate (nPIFR) was studied in a six-week parallel-group trial of NAR (n: 25), and AR (n: 16) patients. Health-related quality of life (HRQoL) and Epworth Sleepiness Scale (ESS) were also analysed. ResultsThe TNSSs, and symptom scores of conjunctivitis, snoring, and postnasal drainage were significantly improved in both groups, after two and six weeks of treatment. In contrast to AR, patients with NAR had statistically significant improvement in nasal obstruction, and postnasal drainage beginning from two weeks of the treatment. nPIFR slightly increased in both groups. Scores of generic (SF-36), rhinitis specific (MiniRQLQ) and ESS questionnaires generally improved better in AR than NAR. TANS was well-tolerated in AR and NAR groups with minor adverse events including headache, nasal burning, and bitter mouth taste. ConclusionsOur study disproved the idea of ineffectiveness of corticosteroid treatment in NAR, and showed that triamcinolone acetate may be an alternative drug in the treatment of NAR.

Normal peak nasal inspiratory flow rate values in healthy children aged 6 to 11 years in the Netherlands

Background: The measurement of peak nasal inspiratory flow (PNIF) is a simple, quick, easy to perform and cheap tool for determining the extent of nasal airway patency. However, normative data are rare and not available for Dutch children aged 6 to 11 years. Methods: Repeated PNIF measurements were obtained from 212 Dutch children of primary school age. Of these 212 children, 166 fulfilled the inclusion criteria of our study. The influence of age, gender, ethnicity, weight and height on PNIF was studied. Results: Age is the only parameter of influence on PNIF. All other parameters do not influence PNIF. Normative data are presented. Conclusion: PNIF measurements are possible in children aged six years and older. Age does influence PNIF, but gender, weight, height and ethnicity do not.

Normal peak nasal inspiratory flow rate values in healthy children aged 6 to 11 years in the Netherlands

Background: The measurement of peak nasal inspiratory flow (PNIF) is a simple, quick, easy to perform and cheap tool for determining the extent of nasal airway patency. However, normative data are rare and not available for Dutch children aged 6 to 11 years. Methods: Repeated PNIF measurements were obtained from 212 Dutch children of primary school age. Of these 212 children, 166 fulfilled the inclusion criteria of our study. The influence of age, gender, ethnicity, weight and height on PNIF was studied. Results: Age is the only parameter of influence on PNIF. All other parameters do not influence PNIF. Normative data are presented. Conclusion: PNIF measurements are possible in children aged six years and older. Age does influence PNIF, but gender, weight, height and ethnicity do not.

Normal peak nasal inspiratory flow rate values in healthy children aged 6 to 11 years in the Netherlands

The measurement of peak nasal inspiratory flow (PNIF) is a simple, quick, easy to perform and cheap tool for determining the extent of nasal airway patency. However, normative data are rare and not available for Dutch children aged 6 to 11 years. Repeated PNIF measurements were obtained from 212 Dutch children of primary school age. Of these 212 children, 166 fulfilled the inclusion criteria of our study. The influence of age, gender, ethnicity, weight and height on PNIF was studied. Age is the only parameter of influence on PNIF. All other parameters do not influence PNIF. Normative data are presented. PNIF measurements are possible in children aged six years and older. Age does influence PNIF, but gender, weight, height and ethnicity do not.

243 Peak Inspiratory Flow Rate is More Sensitive Than Acoustic Rhinometry or Rhinomanometry in Detecting Nasal Obstruction Using the Allergen Challenge Chamber

BackgroundWe prepared an allergen challenge chamber (ACC) which facilitates quantitative pollen challenge at any time, and, so, the acquisition of objective data. The aim of this study was to evaluate peak nasal inspiratory flow rate (PIFR) as an endpoint during allergen challenge and compare this with rhinomanometry (Rhino) and acoustic rhinometry (AR).MethodsThe study was conducted in November, which is not in pollen season. Subjects were exposed to Japanese cedar pollen at a concentration of 50,000 counts/m3in ACC for 120 minutes each day for 2 days. Subject recorded nasal symptoms before challenge and every 15 minutes after challenge initiation. Nasal symptoms (sneezing frequency, nasal blowing frequency, nasal obstruction) were recorded before challenge and every 15 minutes after challenge initiation. For the evaluation of nasal obstruction, we used visual analog scales (VASs); subjects marked a site on a 10-cm line corresponding to the symptom severity on which absence of symptoms was designated as 0 and worst imaginable symptom as 10. PIFR was measured using an In-check flow meter and nasal resistance was measured using Rhino. The cross-sectional area in the nasal cavity was also measured using AR before and after challenge as an indicator of nasal obstruction.ResultsWhen the volunteers with cedar pollinosis were exposed to cedar pollen in ACC, pollinosis symptoms were induced significantly. Changes in the 3 symptoms (sneezing frequency, nose-blowing frequency, nasal obstruction) were investigated before and after challenges on 2 consecutive days. No significant symptoms were induced on the first day of challenge in the non-pollen season. However, each of the 3 symptoms became more severe with second day of challenge, and a significant increase was seen in cumulative values by the second day. In terms of the allergen challenge test, we found a significant correlation between nasal obstruction symptom (VAS) and PIFR, but not AR and Rhino.ConclusionsPIFR after allergen challenge is more sensitive than AR or Rhino in detecting nasal obstruction using the allergen challenge chamber.

Olopatadine 0.6% Nasal Spray Protects from Vasomotor Challenge in Patients with Severe Vasomotor Rhinitis

Vasomotor rhinitis (VMR) is a hypersensitivity syndrome with heightened reactivity to environmental triggers. Twenty-two patients with severe VMR were treated nasally with either normal saline or 0.6% olopatadine and challenged nasally with a hyperosmolar mannitol solution. Treatment with 0.6% olopatadine resulted in an improvement in instantaneous nasal symptom scores at 5 and 30 minutes (p < 0.01) compared with baseline and at 30 minutes after hyperosmolar challenge compared with saline-pretreated individuals (p < 0.01). There was also an improvement in nasal peak inspiratory flow rate at 30 minutes after hyperosmolar challenge compared with saline-pretreated individuals (p < 0.01). In this patient population 0.6% olopatadine appears to be efficacious in symptom reduction in VMR and protects from hyperosmolar challenge.

Nasal inspiratory flow: at rest and sniffing

This study quantifies the time-varying flow rate during inspiration at rest and in sniffing, both predecongestion and postdecongestion. It aims to provide a better understanding of nasal airflow mechanics, for application to the physiological modeling of nasal respiration and to therapeutic drug delivery. The temporal profiles of nasal inspiration were measured at high fidelity in 14 healthy individuals using simultaneous bilateral hot-wire anemometry. Peak nasal inspiratory flow (PNIF) rate, acoustic rhinometry (AR), and the sinonasal outcome test (SNOT) provided complementary clinical measurements. The impact of decongestion was also investigated. In the initial phase of inspiration, a rapid rise in flow rate was observed. Flow first exceeded 150 mL/second in either passage within a median time of approximately 120 ms for inspiration at rest and approximately 60 ms in sniffing (∼20 ms in the fastest sniffs). The mean sustained flow rate attained and the overall period of each measured inspiratory profile were analyzed. AR showed a significant change in nasal volume with decongestion, although these change were not manifest in the temporal profiles of inspiratory flow (barring a weak effect associated with the most vigorous sniffs). Novel methods were applied to investigate the temporal profiles of nasal inspiration. Characteristic features of the profile were identified and found to be significantly different between inspiration at rest and sniffing. Decongestion was found to have little effect on the temporal profiles for the flow regimes studied.

The physiological impact of high altitude on nasal and lower airway parameters

The aim of this study was to investigate the impact of high altitude on nasal and lower airway parameters in a healthy population. This was a prospective study of 61 individuals who climbed to the summit of Mount Kackar, at 3,937 m. Peak nasal inspiratory flow rates were recorded in all participants at sea level and at the summit. In 32 participants who ascended to the summit, sea-level and summit peak expiratory flow rates and olfactory function were evaluated. A rise in altitude significantly decreased peak nasal inspiratory flow by a mean of 27.43%. Mean peak expiratory flow values measured at the summit were 8.94% lower than basal values. Between-value differences were statistically significant (p < 0.001, p < 0.05). At high altitude, there was a significant decrease in olfactory function, as determined by a significant reduction in smell detection (p < 0.05) and smell identification (p < 0.05). The effect of high altitude on nasal function was found to parallel that of the effect on lower airway function, together accounting for an adverse effect on airway flow rates. The nasal mucosa responded to high altitude with an increase in airway resistance and a consequent impaired sense of smell.

Use of intranasal ketorolac and modified oral aspirin challenge for desensitization of aspirin-exacerbated respiratory disease

Intranasal ketorolac challenges can induce respiratory reactions in patients with aspirin-exacerbated respiratory disease (AERD). To determine whether intranasal ketorolac challenges might be used for aspirin desensitization. One hundred patients with suspected AERD who were referred to Scripps Clinic from May 1, 2007 to December 31, 2009 were challenged with 4 increasing doses of ketorolac intranasally at 30-minute intervals. Symptoms, objective changes in the results of their nasal examination, peak nasal inspiratory flow rates, and forced expiratory volume in 1 second (FEV(1)) values were recorded. After nasal ketorolac dosing, patients were given oral aspirin as part of the challenge and desensitization. A control group consisted of 100 patients who had previously undergone our standard oral aspirin challenges and desensitization. Both groups were consecutively enrolled and had similar clinical characteristics. Compared with the standard oral aspirin challenge and desensitization, intranasal ketorolac and modified aspirin challenge significantly attenuated the mean percentage decrease in FEV(1) values (8.5% vs 13.4%; P = .01) and decreased the percentage of extrapulmonary reactions (23% vs 45%; P = .002), particularly laryngospasm (7% vs19%; P = .02) and gastrointestinal reactions (12% vs 33%; P = .001). This new protocol was significantly shorter, lasting an average of 1.9 vs 2.6 days (P = <.001). In fact, 83% of the patients completed the new protocol in less than 48 hours compared with only 20% in the oral challenge control group (P < .001). Intranasal ketorolac challenge and desensitization followed by rapid oral aspirin challenges is effective, safe, and less time-consuming than our standard oral aspirin desensitization protocol.

Comparison of Azelastine versus Triamcinolone Nasal Spray in Allergic and Nonallergic Rhinitis

Intranasal antihistamine has not been thoroughly studied in the treatment of rhinitis of different etiologies. This study was designed to show the comparative efficacy of nasal antihistamine and nasal corticosteroid in patients with allergic rhinitis (AR) and nonallergic rhinitis (NAR). A comparison of the efficacy of azelastine nasal spray (AZENS) versus triamcinolone acetonide nasal spray (TANS) on total nasal symptom scores (TNSS), nasal peak inspiratory flow rate (nPIFR), and nasal cytology was studied in a 2-week randomized parallel-group trial. The Epworth Sleepiness Scale (ESS) and health-related quality of life (HRQoL) were also analyzed. The study group consisted of 132 patients (100 women and 32 men) with a mean age of 33.14 +/- 12.52 years. Sixty-nine patients had AR and 63 had NAR. Although TNSS including sneezing, itching, rhinorrhea, congestion-but not anosmia-significantly improved in both groups, intranasal azelastine reduced ocular symptoms greatly compared with intranasal triamcinolone (p = 0.05). Patients with NAR seemed to respond more to TANS, whereas AZENS was more useful in AR. The nPIFR improved in AR and NAR, with no significant difference between the treatment groups. Neither intranasal azelastine nor intranasal triamcinolone changed cytology in nasal lavage. Both medications were well tolerated, but AZENS led to more adverse events than TANS (56.9 and 19%, respectively; p = 0.001), mainly because of bitter taste. Scores on each domain of generic HRQoL (36-Item Short-Form Health Survey) and mini-rhinitis QoL questionnaires, as well as ESS score, significantly improved in both groups, irrespective of rhinitis etiology. In this first comparative demonstration, AZENS appears to be as effective as triamcinolone in symptom scores, nPIFR, ESS, and HRQoL, equally in AR and NAR.

Efficacy and safety of fixed-dose loratadine/montelukast in seasonal allergic rhinitis: Effects on nasal congestion

A need exists for safe, effective therapy for the relief of the symptoms of allergic rhinitis (AR) that also consistently relieves nasal congestion, the most common and bothersome symptom. This study was performed to assess efficacy and safety of a once-daily tablet containing 10 mg of loratadine, an antihistamine, and 10 mg of montelukast, a leukotriene antagonist (SCH 445761) versus placebo and pseudoephedrine (PSE; 240 mg once-daily formulation; active comparator). In a multicenter, parallel-group, double-blind, double-dummy, randomized study, 1095 subjects with documented history of seasonal AR and positive skin-prick test to a prevailing aeroallergen were treated for 15 days with fixed-dose combination loratadine/montelukast (L/M), PSE, or placebo. After randomization, subjects rated severity of nasal congestion and measured peak nasal inspiratory flow (PNIF) rate in the morning and evening. The change in quality of life from baseline was also assessed. L/M and PSE were significantly more effective than placebo in alleviating nighttime and daytime nasal congestion and improving PNIF rate, an objective measure of nasal obstruction. There were no significant differences between L/M and PSE for any efficacy analysis including improvement in the quality of life. Subjects treated with L/M experienced a similar incidence of total adverse events versus placebo and a lower incidence of total adverse events (including dizziness, insomnia, jitteriness, nausea, and dry mouth) versus PSE. Nasal decongestant activity of L/M was significantly higher than that of placebo and similar to that of PSE in symptomatic AR subjects. L/M showed a safety profile similar to placebo and was better tolerated than PSE. Thus, L/M offers a safe and efficacious alternative to PSE for the treatment of nasal congestion associated with AR.