Nasal Congestion Scores Research Articles

A new therapy (MP29‐02*) effectively treats patients with seasonal allergic rhinitis who suffer most from the bothersome nasal symptom of congestion

• In the ITT population and over the entire 14-day treatment period, MP29-02* most effectively relieved patients’ overall nasal symptoms, reducing the rTNSS from baseline by -5.31 compared to -3.84 for FP (Diff: -1.47; 95% CI: -2.44, -0.50; p=0.0031), -3.25 for AZE (Diff -2.06; 95% CI: -2.98, -1.14; p<0.0001) and -2.20 for PLA (Diff -3.11; 95% CI: -4.03, -2.19; p<0.0001). The relative difference was 47% to FP and 66% to AZE (Figure 2). • MP29-02* relieved patients’ nasal symptoms rapidly, from the first day of assessment to Day 14, with treatment difference and significance maintained at Day 14 vs AZE and FP. • MP29-02* induced the greatest reduction in rTNSS in patients complaining of nasal congestion (-5.64), compared to -3.93 for FP (Diff -1.71; 95% CI -3.00, -0.43; p=0.0093), -3.28 for AZE (Diff -2.36; 95% CI -3.51, -1.21; p<0.0001) and -2.63 for PLA (Diff -3.01; 95% CI -4.14, -1.88; p<0.0001), corresponding to a relative treatment difference of 57% to FP and 79% to AZE (Figure 3). • These nasal congestion-predominant patients treated with MP29-02* also experienced a significantly greater reduction in their nasal congestion score; -1.41 vs -0.90 for FP (Diff: -0.51; 95% CI -0.83, -0.19; p=0.0018), -0.83 for AZE (Diff: -0.58; 95% CI -0.88, -0.29; p=0.0001) and -0.69 for PLA (Diff -0.72; 95% CI -1.02, -0.42; p<0.0001), with a relative treatment difference of 71% to FP and 81% to AZE (Figure 3). • Neither AZE nor FP significantly differed from PLA in terms of nasal congestion reduction in these patients.

Mayo Clinic Internist Offers Pearls for Eldercare

Mayo Clinic Internist Offers Pearls for Eldercare

Increased neutrophilia in nasal polyps reduces the response to oral corticosteroid therapy

Nasal polyps (NPs) are characterized by eosinophilic inflammation, which is generally considered sensitive to corticosteroid treatment. We evaluated levels of neutrophilia in NPs and investigated whether increased neutrophilia in polyp tissue affected the response to corticosteroid treatment. We studied 3 independent cross-sectional groups of patients with NPs. Levels of infiltration by different types of inflammatory cells were determined by using immunohistochemical analyses and compared with those seen in control nasal tissues from subjects without NPs. Levels of inflammatory mediators were measured by using real-time PCR, ELISA, and FlowCytomix analyses. Patients with NPs received oral corticosteroid therapy (30 mg of prednisone once daily for 7 days); clinical parameters of efficacy were associated with NP phenotypes. Among patients with NPs, 76.5% had an eosinophilic phenotype, 46.0% had a neutrophilic phenotype, and 35.8% had a mixed phenotype (indicated by double staining). Overall, patients' symptoms improved after corticosteroid treatment; numbers of eosinophils and levels of their mediators (IL-4 and IL-5), but not numbers of neutrophils or levels of their mediators (IL-8 and interferon-inducible protein 10), were reduced (P< .05). After corticosteroid treatment, patients with the nonneutrophilic phenotype (neutrophil negative) had significantly greater reductions in bilateral polyp size scores, nasal congestion scores, total nasal symptom scores, and nasal resistance than patients with the neutrophilic phenotype (neutrophil positive, P< .05). There are different phenotypes of NPs based on the type of immune cell infiltrate and cytokines produced (eosinophilic or neutrophilic). Patients with the neutrophilic phenotype have less response to treatment with corticosteroids based on symptom scores.

The atopic march: from skin to the airways.

Many patients with atopic eczema (AE) would "march" to develop allergic rhinitis (AR) and asthma. Physicians, patients and their families often do not appreciate the significance of these diseases as co-morbidities of atopy.The aim of this study was to evaluate the prevalence and severity of airway atopies in patients with AE. AR and asthma severity were assessed in consecutive AE patients seen at a pediatric dermatology clinic by ARS (allergic rhinitis score) and ACT (asthma control test). Eczema severity (SCORAD and Nottingham Eczema Severity Score: NESS) were recorded.110 patients with AE and 42 patients without AE were recruited. Allergic rhinitis and asthma were significantly more prevalent in patients with AE [odds ratio for AR was 2.9 (CI: 1.3 - 6.5) and for asthma 4.3 (CI: 1.3 - 16.10)]. 23 (45%) of the AE patients with AR reported that they were currently on oral antihistamine whereas none of the non-AE group reported such usage. Both groups reported relatively higher sneezing and nasal congestion scores and low "eye watering" score. Comparing mild with moderate-to-severe AE, there was essentially no difference between the prevalence of allergic rhinitis and asthma, or severity of symptoms by ARS and ACT, but females reported more severe symptoms of sneezing and itching nose.We conclude that allergic disorders of airway are very common among AE patients independent of the eczema severity. Most of the patients have mild-to-moderate AR and asthma. There is a lot of room for parent/patient education, and childhood eczema may prompt early awareness of these airway co-morbidities of atopy.

Clinical, Double-blind, Placebo-controlled Study Investigating the Combination of Acetylsalicylic Acid and Pseudoephedrine for the Symptomatic Treatment of Nasal Congestion Associated with Common Cold

It was the aim of this clinical study to demonstrate the efficacy of 1000 mg acetylsalicylic acid (ASA, CAS 50-78-2) in combination with 60 mg pseudoephedrine (PSE, CAS 90-82-4), compared with placebo, in the symptomatic treatment of nasal congestion associated with the common cold. A further aim was to demonstrate the efficacy of 500 mg ASA + 30 mg PSE and of 1000 mg paracetamol (CAS 103-90-2) + 60 mg PSE (active control) in the symptomatic treatment of nasal congestion. The study was designed as a randomized, two-center, double-blind, double-dummy, placebo-controlled, parallel-group, single-dose efficacy and safety trial over 6 h and was carried out in the USA. In total, at two centers, 643 patients who had a history and diagnosis of acute upper respiratory tract infection (URTI), were included; they showed symptoms such as nasal congestion, scratchy/sore throat, headache, generalized muscle ache, earache, runny nose, fever, sneezing etc. The investigational drugs ASA and PSE were both provided as granules in sachets and the granules were dissolved in water before administration; the combined preparation of paracetamol + PSE was administered as commercially available tablets encapsulated for blinding. For all preparations, matching placebos were provided. The primary efficacy variable was the area under the curve for differences from baseline on a nasal congestion scale in the first 2 h after treatment. To be eligible for the study, otherwise healthy volunteers were to present with nasal stuffiness of recent onset that reached a score of at least 6 on the 11-point scale for nasal congestion (0 = not stuffy, 10 = very stuffy). The primary analysis of the primary efficacy variable was calculated by analysis of variance including treatment group, severity (moderate/severe) and center as main strata. The analysis was performed using the intent-to-treat population. All active treatments proved to be statistically significantly superior to placebo with regard to the primary efficacy variable. Significant superiority of active treatment compared with placebo could also be demonstrated for an interval of up to 6 h after intake of the drug and for the relief of nasal congestion. The lower dose did not reveal significant different results compared with placebo for relief of nasal congestion in patients with a severe nasal congestion score at baseline. As well in patients with moderate nasal congestion score (NCS) at start of the study the difference from baseline in the NCS compared with placebo was not statistically significant. Thus a trend towards better efficacy in the higher dose could be assumed. No difference was found between 1000 mg ASA + 60 mg PSE and the active control. There were no differences between the two centers. The treatment proved to be safe and well tolerated, without relevant differences between the four treatment groups. Main adverse events were found to be related to the upper respiratory tract infection or were of gastrointestinal nature. In conclusion, the combination of ASA with PSE can be considered as an effective and safe remedial for the symptomatic treatment of the nasal congestion during URTI.

Onset of action of loratadine/montelukast in seasonal allergic rhinitis patients exposed to grass pollen

Given the impact of allergic rhinitis (AR) on quality of life, it is important that AR medications have rapid onset of symptom relief. The objective of this study was to determine the onset of action of loratadine (CAS 79794-75-5)/montelukast (CAS 151767-02-1) 10 mg/10 mg (L/M) versus placebo in seasonal AR (SAR) subjects. In this single-center, double-blind, crossover study, subjects with SAR and confirmed sensitivity to grass pollen received single doses of L/M or placebo following exposure to grass pollen in the Vienna Challenge Chamber. Subjects recorded symptoms at 15-min intervals during the first 2 h post dose and at 30-min intervals during the next 2 h. After a 14-day washout, the subjects crossed over to the other treatment. The primary endpoint was onset of action of L/M, defined as the first time point at which the mean change from baseline in total symptom score became and remained significantly different with L/M versus placebo. Secondary endpoints included nasal congestion score and rhinomanometry findings. Onset of action with L/M for total symptom score was 1 h, 45 min (P < 0.01 vs placebo). Significant improvements in subject-assessed nasal congestion scores (P < 0.01) and rhinomanometry (P = 0.036) were noted with L/M as compared with placebo. Overall, L/M was well tolerated. In conclusion, L/M demonstrated rapid onset for broad symptom relief, including nasal congestion, in subjects with SAR.

Suspension Sutures in Management of Nasal Valve Collapse

Objective: Assess the efficacy of ala suspension sutures in the management of nasal valve collapse causing nasal obstruction. Method: Retrospective study of patients with ala suspension sutures inserted for nasal valve collapse in Doncaster Royal Infirmary from January 2009 to December 2010. Subjective nasal congestion was measured using visual analogue scale (VAS 0-10), and objective measurement using Peak inspiratory flow rate (PIFR) before and after the operation was performed. Results: Twenty-six patients with ala suspension sutures inserted were identified. Five patients who had concurrent procedures carried out on septum and turbinates were excluded. Twenty-one patients were included in our study. Ninety percent of patients were satisfied with the surgery, supported by significant improvement in the VAS (0 - 10) for nasal congestion and PIFR scores. The average VAS score improvement was 4.6 points, and PIFR increased by 23.3L/min. Of the 21 patients, 4 required revision procedures to achieve satisfactory outcome. Two out of these 4 developed neuralgia, which was controlled with Amitriptyline. Conclusion: The result of our study shows a significant improvement in patient symptoms following insertion of ala suspension suture for nasal valve collapse causing nasal obstruction. This is a short and well tolerated procedure with minimal side effects.

Turbinate Size and Sleep‐Related Breathing Disorders: Is There a Correlation?

Objective: The tail of the turbinates is a site of nasal obstruction that may be associated with sleep related breathing disorder (SBD). We describe a technique, the trans-oral nasopharyngoscopy (TON), to evaluate turbinate size and determine if an association exists between turbinate size and the various parameters measured in SBD. Method: Thirty-six patients with SBD completed an Epworth Sleepiness Scale (ESS) and a Quebec Sleep Questionnaire (QSQ). They underwent a nasal examination, allergy skin tests, full night polysomnography, and TON. Turbinate size was divided into two groups: I) turbinate obstructing 1/2. Results: Sixteen patients were grade I and 20 patients were grade II. Turbinate size at the choana did not show any statistical significant association with nasal congestion, allergies, ESS and QSQ scores. Among the PSG parameters analyzed, no association was found with the apnea-hypopnea index (AHI), but the size of the turbinate showed a positive correlation with respiratory event related arousals (RERA; P = .03). Total sleep time spent snoring showed a weak association with turbinate size. Conclusion: TON is a simple technique allowing the evaluation of the size of the turbinates. Turbinate size was associated with RERA and total sleep time spent snoring, but not with AHI.

Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis

Nasal congestion is a frequent, bothersome symptom of seasonal allergic rhinitis (SAR). Mometasone furoate nasal spray (MFNS) has established efficacy in treating nasal allergy symptoms, but no study has been conducted with the primary purpose of evaluating MFNS for relief of congestion. This study assessed MFNS for congestion and other nasal symptoms in SAR. Two double-blind, placebo-controlled studies randomized symptomatic SAR patients to 15 days of MFNS, 200 micrograms, or placebo q.d. each morning. Participants scored individual components of total nasal symptom score (TNSS; congestion, rhinorrhea, sneezing, and itching) on a 4-point scale in the morning (A.M.) and evening (P.M.). Symptoms were scored for the time of assessment (NOW) and for the previous 12 hours (PRIOR). The pooled population comprised 684 patients randomized to MFNS (n = 344) or placebo (n = 340). Change from baseline in A.M./P.M. PRIOR nasal congestion score averaged over days 1-15, the primary end point, was significantly (p < 0.001) greater with MFNS than with placebo (0.68-point [25.2%] reduction versus 0.45-point [16.0%] reduction, respectively). Reduction in A.M./P.M. PRIOR TNSS averaged over days 1-15, a key secondary end point, was also superior with MFNS (2.83 points [28.5%] versus 1.79 points [17.6%]; p < 0.001). Predose A.M. NOW congestion, other nasal symptoms, and TNSS improved significantly more with MFNS, indicating 24-hour efficacy. Adverse events were infrequent and localized; the most common (epistaxis and pharyngolaryngeal pain) occurred in 1.0% of MFNS patients. MFNS q.d. provides sustained relief for nasal congestion and other SAR symptoms.

Efficacy and safety of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis

This study evaluated the efficacy and safety of mometasone furoate nasal spray (MFNS) in patients with chronic sinusitis. In this double-blind, placebocontrolled, multicenter, parallel-group study, 60 patients with persistent sinusitis symptoms were randomized to receive either MFNS 200 μg twice daily or placebo, for 16 weeks (112 days). Eventually, 53 patients terminated the study in regular course. Total Symptom Scores (TSS) in patients receiving MFNS changed by a mean of -7.27 (95% CI -9.71, -4.84), versus -5.35 (95% CI -6.73, -3.96) in the placebo group (P=0.51). MFNS reduced nasal congestion and discharge scores, and improved patients' olfactory function. There were few side effects. Considerably more patients in the MFNS group were satisfied with the treatment than those who had received placebo (P<0.05). Also, more patients would take the medication again in the event of symptoms, compared with those who had taken placebo (P<0.05). Furthermore, the MFNS patients would recommend it to others. The positive patient assessment and few side effects are reflected in the efficacy evaluation performed by the physicians. The endoscopic results under MFNS were always numerically more favorable than those under placebo, and the overall difference reached statistical significance (P<0.01). MFNS offers an effective and safe treatment for chronic rhinosinusitis.

Endonasal phototherapy significantly alleviates symptoms of allergic rhinitis, but has a limited impact on the nasal mucosal immune cells

The literature documents the fact that UV irradiation of cutaneous Langerhans cells (LC) in vivo prevents the development of contact allergy and produces long-lasting immunosuppression. However, not much is known about the effect of UV irradiation on the LC of the nasal mucosa and their connection with clinical scores. Local antigen presentation may be necessary for both primary and recall T cell responses to birch pollen in patients with hay fever. Endonasal phototherapy combination of UVB (5%), UVA (25%) and visible light (70%) utilises the immunosuppressive effects of UV irradiation. The aim of this study was to correlate clinical symptom scores with possible changes in the LC of the nasal mucosa induced by UV radiation. The clinical effectiveness of this form of treatment is discussed. Nasal biopsies were obtained from ten birch pollen-sensitive patients with seasonal rhinitis before and after endonasal phototherapy. All patients showed a significant clinical benefit post-treatment as assessed by standardised instruments, including total nasal symptom score, nasal congestion score, nasal itching score, sneezing score, nasal secretion score and impairment-to-health score. However, we found no significant morphological changes, to, or quantitative differences in, the CD1a+, CD4, CD8 or CD31 cells before and 14 days after treatment. Despite the positive clinical effect, the study revealed no effect of UV irradiation on the LC and other analysed cells of the nasal mucosa immune system. Possible reasons for this are discussed.

Efficacy and Safety of Once Daily Fluticasone Furoate Nasal Spray for Treatment of Irritant (Non-allergic) Rhinitis.

Introduction: The safety and efficacy of fluticasone furoate nasal spray (FFNS) for the symptoms of seasonal and perennial allergic rhinitis have been previously demonstrated in several clinical studies. The objective of this pilot study was to compare the efficacy and safety of FFNS 110 mcg once daily with placebo in patients with irritant (non-allergic) rhinitis triggered predominantly by air pollution.Methods: This was a randomized, double-blind, placebo-controlled, 4-week study of subjects in Thailand with irritant rhinitis who received either FFNS 110 mcg (N=53) or placebo (N=49) once-daily. Subjects with a ≥2 year history of air pollution as their predominant rhinitis trigger, negative skin test to local seasonal/perennial allergens, positive histamine skin test, and normal sinus radiograph were enrolled if they met minimum reflective total nasal symptom score (rTNSS) ≥4.5 (maximum=9) and a nasal congestion score of ≥2 (maximum =3). All were assessed for nasal eosinophilia at study entry and completion. Air quality was monitored throughout the study. The primary efficacy endpoint was the mean change from baseline over the treatment period in daily rTNSS, the average of the morning and evening rTNSS. The key secondary measure was the mean change from baseline over the entire treatment period in morning pre-dose instantaneous total nasal symptom score (iTNSS).Results: The Air Quality Index (AQI) during the study generally did not reach unhealthy levels. Baseline daily rTNSS scores were similar between treatment groups (FFNS=6.7; placebo=6.4). The least square mean change from baseline in rTNSS was -2.17 and -2.10 for FFNS and placebo, respectively, with a difference of -0.065 (p=0.845). Gradual improvements were seen in both treatment groups for iTNSS; however, the treatment difference (-0.075) was not statistically significant (p=0.827). Additionally, there were no statistically significant differences between treatment groups for AM and PM rTNSS, individual nasal symptoms, daily reflective, AM and PM reflective and AM pre-dose instantaneous total ocular symptom scores (TOSS) or individual ocular symptom scores. Nasal cytology at baseline found more than two-thirds of subjects had <20% eosinophils. Adverse events were few and similar between groups and noted as mild in intensity.Conclusion: Subjects receiving FFNS had similar improvement to placebo in their rhinitis symptoms. The lack of a treatment effect may be in part due to the overall good air quality present throughout the study or an insufficient dose or duration of FFNS. The safety findings showed FFNS 110 mcg once daily to be well tolerated.

Onset of action of loratadine/montelukast combination in subjects with seasonal allergic rhinitis in the environmental exposure unit

Methods A single-center, double-blind, parallel-group study of ragweed-sensitive allergic rhinitis subjects (N=310), performed in the EEU. Subjects were exposed to ragweed pollen in the EEU and symptoms were recorded at 30, 60, 90, and 120 minutes prior to a single dose of loratadine/montelukast or placebo. After dosing, symptoms were recorded for 4 hours at 15-minute intervals for the first 2 hours and 30-minute intervals for the final 2 hours. The primary endpoint was the time to onset of action for loratadine/montelukast, defined as the first time point at which the mean change from baseline in total symptom score (TSS) for loratadine/montelukast became and remained significantly better than placebo. Secondary endpoints included nasal congestion scores and peak nasal inspiratory flow (PNIF).

Desloratadine relieves nasal congestion and improves quality‐of‐life in persistent allergic rhinitis

Symptoms of allergic rhinitis (AR), particularly nasal congestion, can impair quality-of-life (QoL). However, only a modest correlation exists between these symptoms and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores, suggesting that both be evaluated for a complete assessment of health. Subjects with a > or =2-year history of moderate-to-severe AR to dust mite or cat dander were randomized to desloratadine 5 mg/day (n = 293) or placebo/day (n = 291) for 28 days. Primary endpoint was change from baseline in a.m./p.m. nasal congestion score. Secondary outcomes included change from baseline in total nasal symptom score, individual symptom scores and RQLQ scores (completed on days 1, 7, and 28). The Allergic Rhinitis and its Impact on Asthma criteria for persistent allergic rhinitis (PER) were fulfilled by 99% of subjects in the placebo arm. Between-treatment difference in a.m./p.m. nasal congestion score, observed from day 8 onward, significantly favored desloratadine (P = 0.0003). Desloratadine significantly improved a.m./p.m. nasal congestion and RQLQ scores after 1 week and at treatment end (P < 0.05). Improvements in 5 of 7 RQLQ domain scores exceeded the minimal important difference. On days 7 and 28, desloratadine was also significantly superior to placebo in mean change from baseline in a.m./p.m. total nasal symptom score and rhinorrhea score (both P < or = 0.01). Symptomatic benefit was primarily driven by improvement in nasal congestion and rhinorrhea. Desloratadine 5 mg/day significantly improved symptoms associated with PER, including nasal congestion, and provided significant improvement in QoL after 1 week of treatment.

Desloratadine and pseudoephedrine combination therapy as a comprehensive treatment for allergic rhinitis and nasal congestion

Background: Allergic rhinitis (AR) is rapidly increasing in global prevalence. Symptoms of AR, particularly nasal congestion, can cause quality of life (QoL) impairment. Second-generation antihistamines are a recommended first-line therapy for AR but are not viewed as very effective for the treatment of congestion. Therefore, an antihistamine plus a decongestant, such as the combination of desloratadine and pseudoephedrine, is a convenient and efficacious treatment. Objective: To review the clinical evidence on the efficacy and safety of combination desloratadine/pseudoephedrine for the treatment of AR symptoms, particularly nasal congestion. Results: Four large studies found that improvement in nasal congestion is enhanced when patients are treated with combination desloratadine/pseudoephedrine. The combination drug significantly improved mean reflective nasal congestion scores in these studies compared with either component as monotherapy (p ≤ .009 for all). These improvements in congestion were observed by day 2. Mean reductions in nasal congestion scores were comparable between the once- and twice-daily dosing regimens of the combination drug. Conclusion: Comprehensive treatment of AR that effectively relieves nasal congestion can also improve patient QoL. Administration of the second-generation antihistamine desloratadine in combination with the decongestant pseudoephedrine may be regarded as an efficacious and convenient option for patients with AR who are particularly troubled by nasal congestion.

Onset of action of loratadine/montelukast in seasonal allergic rhinitis subjects exposed to ragweed pollen in the Environmental Exposure Unit

Onset of action is recognized as an important pharmacologic property of allergic rhinitis (AR) medications. This study was designed to evaluate the onset of action of loratadine/montelukast (L/M; 10 mg/10 mg) versus placebo in subjects with ragweed-induced seasonal AR (SAR). A single-center, double-blind, parallel-group study of ragweed-sensitive AR subjects (n = 310) was performed in the Environmental Exposure Unit (EEU). Subjects were exposed to ragweed pollen in the EEU and symptoms were recorded at 30, 60, 90, and 120 minutes before a single dose of L/M or placebo. After dosing, symptoms were recorded for 4 hours, at 15-minute intervals for the first 2 hours and at 30-minute intervals for the final 2 hours. The primary end point was time to onset of action of L/M, defined as the first time point at which the mean change from baseline in total symptom score (TSS) for L/M became and remained significantly better than placebo. Secondary end points included nasal congestion scores and peak nasal inspiratory flow (PNIF). The onset of action of L/M for TSS was 1 hour and 15 minutes (p = 0.005 versus placebo). L/M reduced nasal congestion as indicated by significant improvements in both the nasal congestion score (p = 0.011) and the PNIF measurements (p = 0.007) within 1 hour and 15 minutes postdose. The incidence of treatment-emergent adverse events was similar between groups. The onset of action after treatment with L/M was 1 hour and 15 minutes for TSS, as well as nasal congestion. L/M was well tolerated.

Functional endoscopic sinus surgery improved asthma symptoms as well as PEFR and olfaction in patients with nasal polyposis

Nasal polyposis is a disease known to be associated with asthma. The management is anti-inflammatory, with topical and oral corticosteroids as the first-line treatment. The effect of surgical treatment on lower airway inflammation has not been sufficiently studied. The aim of this study is to investigate the effects of functional endoscopic sinus surgery (FESS) as well as fluticasone proprionate nasal drops (FPND) 400 microg b.i.d. on nasal and lower airway parameters in asthmatics with nasal polyposis. This was a prospective 21-week study of 68 patients with asthma and nasal polyposis, on the benefits of FESS on nasal '(butanol test, subjective olfaction, peak nasal inspiratory flow, congestion, rhinorrhoea, and polyp score)', and on the lower airway parameters (dyspnea, cough, mean daily peak expiratory flow rate (PEFR), and lung function tests). It also included a randomized, double-blind, placebo-controlled 14 weeks phase on FPND. Functional endoscopic sinus surgery significantly improved mean asthma symptom scores and daily PEFR and all nasal parameters including subjective and objective olfaction tests. This is the first study that shows the benefits of FESS on butanol tests in patients with nasal polyposis. We found no significant difference between topical treatment with FPND or placebo in the nasal or lower airway variables. Functional endoscopic sinus surgery improved nasal and asthma symptoms in patients with nasal polyposis. Functional endoscopic sinus surgery could be considered early in the natural course of nasal polyposis with concomitant asthma, as well as a second-line treatment in nasal polyposis patients with a reduced sense of smell. The potential benefits of FPND 400 microg b.i.d. were probably overshadowed by FESS.

Efficacy of loratadine-montelukast on nasal congestion in patients with seasonal allergic rhinitis in an environmental exposure unit

Nasal congestion is considered to be one of the most bothersome symptoms of allergic rhinitis (AR) and often the most difficult to treat. Oral therapies providing safe, effective, and reliable relief of AR symptoms, including nasal congestion, are limited. To evaluate the efficacy of a single dose of loratadine-montelukast (10 mg/10 mg) vs placebo and phenylephrine (10 mg) in relieving nasal congestion over 6 hours after ragweed pollen exposure in the environmental exposure unit at the Kingston General Hospital. After a screening visit and up to 6 priming visits, patients who met minimum symptom requirements during ragweed pollen exposure were randomized to receive loratadine-montelukast, phenylephrine, or placebo. Patients evaluated nasal congestion and other symptoms of AR and measured peak nasal inspiratory flow before dosing and at 20-minute intervals during the subsequent 8 hours of pollen exposure. During the first 6 hours after treatment (primary end point), loratadine-montelukast treatment resulted in greater improvement in the mean nasal congestion score vs placebo (P = .007) and phenylephrine (P < .001). Loratadine-montelukast was more effective than placebo (P < or = .02) and phenylephrine (P < or = .002) in relieving total symptoms, nasal symptoms, and nonnasal symptoms and in improving peak nasal inspiratory flow. There were no statistically significant differences between phenylephrine and placebo for any measures. Fewer patients in the loratadine-montelukast group (3.9%) reported adverse events than in the phenylephrine (7.9%) and placebo (7.1%) groups; most adverse events were mild or moderate. Loratadine-montelukast was more effective than placebo and phenylephrine in relieving nasal congestion and other nasal and nonnasal symptoms resulting from ragweed pollen exposure. There was no statistically significant difference between phenylephrine and placebo.

Cedar and Cypress Pollinosis and Allergic Rhinitis: Quality of Life Effects of Early Intervention with Leukotriene Receptor Antagonists

Background: Allergic rhinitis involves inflammation of the nasal passages. The use of nasal steroids is generally very effective in providing significant symptom relief. However, compliance for their use is sometimes poor. Methods: To examine the efficacy of early intervention (before pollen dispersal) with oral cysteinyl leukotriene receptor antagonists (LTRA) on pollinosis in patients with allergy to cedar and Japanese cypress pollens, groups of subjects were treated with LTRA or a placebo for 4 weeks at the beginning of the cedar pollen dispersal season. Subsequently, all patients received nasal steroid therapy concomitantly with LTRA throughout the remaining period of the pollen dispersal season. The effects of such early treatment with LTRA on pollinosis were investigated using symptom scores from an allergy diary and quality of life (QOL) scores. Results: Sneezing and nasal congestion scores were significantly lower in the LTRA-pretreated subjects than observed in the placebo-pretreated patients between weeks 4 and 6 and weeks 3 and 5, respectively. QOL scores improved significantly in all domains after concomitant therapy with nasal steroids. The percent improvement in the nasal congestion score after the concomitant therapy was significantly higher in the LTRA group (69%) than in the placebo group (41%). Conclusion: Significant differences observed in symptoms and in QOL effects between LTRA- and placebo-pretreated patients and the absence of major adverse effects noted in these studies suggest that early intervention with LTRA is beneficial and safe and should be considered in the management of pollinosis-associated allergic rhinitis.

A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber

Studies on the efficacy of phenylephrine in the treatment of nasal congestion have yielded inconsistent results, notwithstanding its approval for this indication. To evaluate and compare the decongestant effect of a single dose of phenylephrine to placebo and pseudoephedrine in patients with seasonal allergic rhinitis. This randomized, placebo-controlled, 3-way crossover study evaluated patient-scored nasal congestion, peak nasal inspiratory flow, and rhinomanometry at more than 6 hours in 39 grass-sensitive patients exposed to grass pollen in the Vienna Challenge Chamber. Patients were dosed with immediate-release formulations of phenylephrine, 12 mg, pseudoephedrine, 60 mg, as a control, or placebo. Phenylephrine was not significantly different from placebo in the primary end point, mean change in nasal congestion score at more than 6 hours (P = .56), whereas pseudoephedrine was significantly more effective than both placebo (P < .01) and phenylephrine (P = .01). Phase 1 results showed a difference between phenylephrine and placebo that was 64% of the difference between pseudoephedrine and placebo, substantially greater than the 17% difference observed for all phases. Carryover bias due to patient recall of the pseudoephedrine effect may have influenced these results. Rhinomanometry and peak nasal inspiratory flow results were consistent with these data. Neither phenylephrine nor pseudoephedrine had an effect on the nonnasal symptoms. No adverse events were reported in this study. During a 6-hour observation period, a single dose of pseudoephedrine but not phenylephrine resulted in significant improvement in measures of nasal congestion. Neither phenylephrine nor pseudoephedrine had an effect on nonnasal symptoms.