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Background: It is unclear what constitutes a clinically meaningful response for allergic rhinitis (AR) outcomes. The objectives of these post hoc analyses were (1) to define a clinically meaningful response using novel efficacy analyses (including a responder analysis), and (2) to compare the efficacy of MP29-02 [a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP)] with commercially available FP, AZE and placebo in seasonal AR (SAR) patients, using these novel analyses. Methods: 610 moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Change from baseline in the reflective total nasal symptom score (rTNSS) over 14 days was the primary outcome. Post hoc endpoints included the sum of nasal and ocular symptoms (rT7SS), efficacy by disease severity and by predominant nasal symptom, and a set of responder analyses. Results: MP29-02 most effectively reduced rT7SS (relative greater improvement: 52% to FP; 56% to AZE) and both nasal and ocular symptoms irrespective of severity. More MP29-02 patients achieved a ≥30, ≥50, ≥60, ≥75 and ≥90% rTNSS reduction, which occurred days faster than with either active comparator; MP29-02 alone was superior to placebo at the ≥60% (or higher) threshold. One in 2 MP29-02 patients achieved a ≥50% rTNSS reduction and 1 in 6 achieved complete/near-to-complete response. Only MP29-02 was consistently superior to placebo for all patients, whatever their predominant symptom. Conclusions: MP29-02 provided faster and more complete symptom control than first-line therapies. It was consistently superior irrespective of severity, response criteria or patient-type, and may be considered the drug of choice for moderate-to-severe AR. These measures define a new standard for assessing relevance in AR.

Purpose To determine the effect of a controlled heated breathing tube humidifier (cHH) on the quality of life (QOL), compliance and nasopharyngeal side effects during continuous positive airway pressure (CPAP) therapy in patients with obstructive sleep apnea syndrome (OSAS) in comparison with conventional CPAP. Methods In this prospective randomised cross-over study, 44 patients with OSAS were investigated. During the first two consecutive treatment nights monitored by polysomnography, patients were randomly assigned to receive CPAP with or without cHH. Patients were then randomised to receive one of the treatment modalities at home for 4 weeks. Compliance was recorded and questionnaires assessing side effects and QOL were administered. Results Sleep parameters measured during the nights in the sleep laboratory did not change. The same result applied to QOL and compliance measured after 4 weeks. During the first two nights we found significant differences between CPAP with and without cHH for dryness of mouth (2.0 ± 1.4 vs. 1.4 ± 1.6) in favour of cHH ( p  < 0.05). Evaluation of coldness of the face showed improvement whereas waking up due to wetness on the face (0.3 ± 0.6 vs. 0.6 ± 0.8; p  < 0.05) was slightly increased. Data after 4 weeks confirmed these findings with further subjective improvement in the reduction of side effects. Conclusions By the using of the technology of cHH QOL and compliance did not improve. The side effects of CPAP therapy without humidification with respect to nasopharyngeal dryness, however, was reduced immediately as well as during the first weeks of treatment.

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.

Fluticasone furoate nasal spray (FFNS) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the treatment of allergic rhinitis. No previous clinical studies have compared the efficacy of FFNS with another intranasal steroid. The purpose of this study was to compare the efficacy and safety of FFNS, 110 μg/day, once daily with fluticasone propionate nasal spray (FPNS), 200 μg/day, twice daily in patients with Japanese cedar pollinosis to support the regulatory filing in Japan. In this multicenter, randomized, placebo-controlled, double-blind, parallel-group study, patients (≥16 years old) were randomized to receive 2 weeks of treatment with FFNS (n = 151), FFNS placebo (n = 72), FPNS (n = 148), or FPNS placebo (n = 75). FFNS once daily was noninferior to FPNS twice daily in mean change from baseline in three total nasal symptom scores (3TNSS; sneezing, rhinorrhea, and nasal congestion; −1.23 ± 0.140 and −1.06 ± 0.142, respectively). Compared with placebo, FFNS was superior in reducing 3TNSS (p < 0.001). Both FFNS and FPNS showed similar mean changes from baseline in 4TNSS (3TNSS and nasal itching) and individual nasal symptom scores. The onset of action for FFNS was observed from the 1st day of treatment, whereas in the FPNS group it was observed on the 2nd day. There were similar improvements in rhinoscopy findings, activity of daily life interference, and patient-rated overall evaluation to therapy in the FFNS and FPNS groups. FFNS was well tolerated. Treatment with once-daily FFNS was effective and noninferior to twice-daily FPNS in reducing nasal symptoms. Faster onset of action for FFNS was observed.

ObjectiveThe aim of this study is to evaluate the impact of rapid palatal expansion (RPE) on the nasal airway subjectively by utilizing patient-reported outcome measures (PROM) and objectively by evaluating validated internal nasal valve (INV) measurements obtained from cone beam computed tomography (CBCT) in pediatrics.Materials and methodsIn this retrospective cohort study, subjects who underwent RPE from March to December 2018 with cone beam CT and Nasal Obstruction Symptom Evaluation (NOSE) scores were included. Exclusion criteria included craniofacial deformity, allergies, asthma, recent nasal trauma, or surgery. INV measurements (angle and cross-sectional area), diastema, midpalatal suture opening, and NOSE scores were evaluated.ResultsFifty-one subjects met the inclusion criteria with a mean age of 10.1 ± 2.6. Pre-expansion mean NOSE score was 32.55 (moderate) while post-expansion was 13.92 (mild). Mean NOSE score improved significantly by an average of 18.63 following post-expansion (P < 0.0001). The patients’ right and left INV angles increased significantly by a mean of 2.42° and 2.65° respectively (P < 0.0001). Right and left INV cross-sectional areas increased significantly by an average of 14.35 mm2 (P < 0.0001) and 14.17 mm2 (P < 0.0001) respectively. An average expansion of the diastema and the suture was 1.60 mm and 3.05 mm respectively (P < 0.0001), with an average of 6.29 mm of expansion. We found the amount of diastema expansion to correlate with change in NOSE score (R = − 0.32, P = 0.022). Age and diastema showed a negative correlation (R = − 0.44, P = 0.0019), while INV angle and diastema showed a statistically significant positive correlation (R = 0.28, P = 0.048).ConclusionsRPE showed improvement in both NOSE scores and objective measures of the INV. This may show the possibility of considering RPE in managing resistant pediatric nasal airways. Future studies should include collaboration with pediatric otolaryngologists, with the inclusion of pediatric patients with persistent nasal obstruction.

The objective of this study was to compare the effectiveness of montelukast combined with loratadine once daily to loratadine alone for a 2-week treatment course of allergic rhinitis in a randomized, double-blind placebo controlled trial which enrolled 115 children, 6- 15-years-old. The patients were randomly assigned to receive montelukast and loratadine (treatment group) or placebo and loratadine (control group). The primary outcome was the mean percent change of the total daytime nasal symptom scores (PDTS) and secondary outcomes were the mean percent changes of the nighttime nasal, daytime eye and composite symptom scores (PNTS, PES, PCS), as well as the nasal secretion, turbinate swelling and nasal congestion scores (PNSS, PTSS, PNCS). There were no significant differences in the PDTS of the 2 groups. The change in the night time nasal congestion score (PNTS-congestion) was higher in the treatment group, but not statistically significant (p = 0.077). Only the mean percent change in decreased turbinate swelling was significantly greater in the montelukast and loratadine group than the loratadine alone group (-22 +/- 7 vs. -1 +/- 5, p < 0.05).

To determine whether: the N95 respirator affects nasal valve patency; placement on the bony vault improves patency; and external nasal anatomy affects the outcome. A prospective study with 50 participants was conducted. Nasal patency was measured by the minimal cross-sectional area via acoustic rhinometry, and using the Nasal Obstruction Symptom Evaluation survey, before and after wearing the N95 respirator and after adjustment. The minimal cross-sectional area was narrowed by 27 per cent when wearing the N95 respirator (p < 0.001), and improved by 9.2 per cent after adjustment (p = 0.003). The total Nasal Obstruction Symptom Evaluation score increased from 10.2 to 25.4 after donning the N95 respirator (p < 0.001), and decreased from 25.4 to 15.6 after adjustment (p < 0.001). There was no correlation with external nasal anatomy parameters. Wearing the N95 respirator causes narrowing of the nasal valve, and adjustment onto the bony vault improves symptoms. The findings were not affected by external nasal anatomy.

IntroductionThe position of the lower lateral cartilages (LLC) is closely related to the function of the external nasal valve (ENV). When there is a cephalic malposition of these cartilages, the nasal alae have inadequate support, which leads to ENV insufficiency during deep inspiration.MethodsRetrospective study with 60 patients evaluated: the positioning of the LLC and the occurrence of ENV insufficiency; the effectiveness of structuring the medial and lateral walls of the ENV; and the frequency of the grafts used for structuring it.ResultsOf the 60 operated cases, 37 patients (62%) had ENV insufficiency, in 23 cases there was cephalic malposition of the LLC, and in the latter group 17 patients (74%) presented this insufficiency. A structured ENV was effective in the treatment of this insufficiency (p = 0.001). A lateral crural strut graft was performed in 24 cases (40%) of 60 patients operated. The alar contour graft was performed from 2013 to 2015 in 4 patients (22%) of 18 cases operated, and between 2016 and 2018 it was performed in 29 patients (69%) out of 42 cases. The columellar strut was routinely used from 2013 to mid-2016 in 33 cases (100%), and after that period until the present day the tongue-in-groove technique was performed in 11 cases (41%) and in the remaining 16 cases (59%) the caudal septal extension graft was performed.ConclusionCephalic malposition of the LLC is an important red flag of ENV insufficiency. This insufficiency should be treated by structuring the walls of the ENV.Level of Evidence IVThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Objective: To study the role of mitomycin C in reducing adhesion formation following endoscopic sinus surgery. Study design: Prospective, randomized, controlled trial. Setting: Tertiary care referral centre. Patients: Thirty patients were selected suffering long-term problems with bilateral chronic rhinosinusitis, with no relief obtained from medical therapy. Patients requiring revision sinus surgery or having acute upper respiratory tract infection were excluded. Interventions: Diagnostic nasal endoscopies and non-contrast computerized tomography of nose and paranasal sinuses were undertaken and, following confirmation of the diagnosis, functional endoscopic sinus surgery (FESS) was carried out bilaterally using the Messerklinger technique. On completion of the surgery, a cotton wick soaked in mitomycin C was placed in one or other side of the nose in the middle meatus. Follow up was for three months and patients were assessed for subjective and objective improvement in their symptoms. Results: Post-operatively, of the 11 (36.6 per cent) patients complaining of persistent nasal obstruction, nine had complaints limited to the control side only (p=0.005). Out of the nine (30 per cent) patients complaining of recurrent nasal discharge, eight had complaints on the control side and only one reported discharge from both sides (p=0.006). Conclusion: Mitomycin C may be topically applied in post-operative FESS cases to reduce adhesion formation and hence the need for revision surgery.

Endoscopic frontal sinus surgery is frequently complicated by post-operative stenosis and obstruction of the frontal sinus outflow tract, resulting in recurrent disease. Frontal sinus stents may help prevent re-occlusion of the frontal neo-ostia. This paper presents a simple and cost-effective approach to frontal sinus stenting using modified Silastic nasal splints. The current technique provides an effective, reliable and inexpensive method for achieving post-operative frontal sinus outflow tract patency.