Impact of rapid palatal expansion on the internal nasal valve and obstructive nasal symptoms in children.

OBJECTIVE: The 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 METHODS: In 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. RESULTS: Fifty-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). CONCLUSIONS: RPE 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.

Cryosurgical ablation for treatment of common warts on the nasal vestibule.

BACKGROUND: Common warts rarely occur on the nasal vestibule. It should be treated more carefully than other skin lesions because scar contracture results in the narrowing of the external naris, causing nasal obstruction and reducing the patient's quality of life. In this report, we introduce our method for common warts on the nasal vestibule using handheld cryoablation devise. PATIENTS AND OPERATIVE METHODS: We performed a series of four cryosurgical ablation procedures to treat common warts on the nasal vestibule. All the procedures employed a reusable handheld cryoablation device (CRY-AC®, Brymill Cryogenic Systems, Ellington, CT). RESULT: All patients were successfully treated for four to six sessions without any adverse event. CONCLUSION: Cryotherapy for common warts on nasal vestibular is easily performed in an office setting under no anesthesia without bleeding. We believe this easy and safe procedure is suitable as the first line therapy for common wart on nasal vestibular.

Comparative study of nasal septal retainer and nasal packing in patients undergoing septoplasty.

PURPOSE: Nasal packing is frequently used after septoplasty and some complications caused by nasal packing are unavoidable. A nasal septal retainer has recently been developed. We evaluated the safety and clinical efficacy of the retainer in septoplasty, and the subjective symptoms of patients with the retainer were compared with Merocel nasal packing. METHODS: A prospective, randomized, controlled study was performed in patients who had undergone septoplasty. In total, 39 patients were randomized to receive Merocel (n = 17) or the retainer (n = 22) after septoplasty. The deviation of nasal septum and nasal mucosa was evaluated by endoscopy. The clinical efficacy and subjective symptoms were compared using the visual analog scale. RESULTS: During the packing/retaining period, the mean scores of headache, nasal obstruction, epiphora, and facial pressure in the retainer group were significantly lower than in the Merocel group (P < 0.05); the mean scores of nasal pain, nasal itching, rhinorrhea, dysphagia, and sleep disturbance in the retainer group were lower than in the Merocel group, but the difference did not reach statistical significance. On the removal of Merocel/retainer, nasal pain was significantly lower in patients with the retainer (P < 0.05). In the retainer group, the incidence of grade 1 bleeding was 45.5%, and grade 0 bleeding was 54.5%. In the Merocel group, the incidence of grade 2 bleeding was 23.5%, grade 1 was 47.1%, and grade 0 was 29.4%. CONCLUSIONS: The nasal septal retainer is suitable for use after septoplasty with more beneficial effects than nasal packing.

Budesonide nasal irrigation improved Lund-Kennedy endoscopic score of chronic rhinosinusitis patients after endoscopic sinus surgery.

PURPOSE: Budesonide improves the prognosis of chronic rhinosinusitis (CRS). However, few reports have examined whether its use for nasal irrigation, compared to normal saline, improves the prognosis of patients after endoscopic sinus surgery (ESS). We compared the effects of nasal irrigation with budesonide and normal saline in CRS patients after ESS. METHODS: Sixty CRS patients who had undergone ESS were randomly divided into an experimental group (30 patients), which used budesonide nasal irrigation, and a control group (30 patients), which used normal saline nasal irrigation. All patients received regular follow-up evaluations and were assessed via questionnaires, including the Lund-Kennedy endoscopic score (LKES), the symptom visual analog scale (VAS), the 22-item Sino-Nasal Outcome Test (SNOT-22), the Short-Form 36-Item Questionnaire (SF-36), the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS) and a side effects scale. RESULTS: Scores of polyposis, mucosal edema, secretions and total score of LKES; VAS scores of nasal blockage, hyposmia and rhinorrhea; and SNOT-22 results in both groups were significantly improved 3 months after ESS. Scores of polyposis, mucosal edema, secretions and scarring and total score of LKES in experimental group were significantly better than in control group 3 months after ESS. No significant differences were observed in SF-36, SAS or SDS before or 3 months after ESS within or between the two groups. The side effects of the two groups were not significantly different. CONCLUSIONS: Nasal irrigation improved the prognosis of CRS patients after ESS. Budesonide nasal irrigation had a better effect than normal saline nasal irrigation.

Comparing the Health Burden of Living With Nasal Deformity in Actual Patients and Healthy Individuals: A Utility Outcomes Score Assessment.

BACKGROUND: Rhinoplasty is a one of the most commonly performed facial surgery aiming at restoring facial aesthetics and improving quality of life. Utility outcome scores are modern, and emerging tools are used to evaluate the burden of a health state on individuals. The study aims to evaluate the impact of living with nasal deformity among real patients and healthy individuals using utility outcome scores. METHODS: A cross-sectional study was conducted at Otolaryngology and Plastic Surgery clinics in a tertiary center. Healthy individuals were recruited from public facilities. A case scenario was developed to reflect an imaginary patient (Nora) with a functional and aesthetic nasal deformity and distributed to participants. Three utility outcomes scores were used: visual analog scale (VAS), time trade-off (TTO), and standard gambling (SG). RESULTS: A total of 407 adult participants were included. Most participants were female (52%). Healthy individuals comprised 71%, and actual patients comprised 29%. Mean VAS score was 0.77 (ie, participants scored Nora's health state as 77%), TTO score was 0.87 (ie, participants were willing to sacrifice 4 years to have Nora's condition corrected), and SD score was 0.91 (ie, participants were willing to take a 9% risk of death to have Nora's condition corrected). Scores differed among actual patients and healthy individuals (P < 0.0001 for VAS and TTO, P = 0.02 for SG). CONCLUSION: Living with a nasal deformity has a significant impact on quality of life. Both patients and healthy individuals are willing to trade a significant number of years to get the condition corrected.

The Relation Between the Lower Lateral Cartilages and the Function of the External Nasal Valve.

INTRODUCTION: The 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. METHODS: Retrospective 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. RESULTS: Of 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. CONCLUSION: Cephalic 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 IV: This 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 .

Improving Postoperative Nasal Airway Patency in Le Fort-Based, Maxillofacial Trauma Patients Via a Modified Nasal Packing Technique.

INTRODUCTION: Combined mid-face and nasal apparatus trauma injuries pose a significant challenge to airway patency (AW), in the immediate postoperative setting following fracture reduction. As such, the authors describe a modified technique with the goal of maintaining a patent nasal AW, while at the same time, minimizing nasopharyngeal bleeding and nasal AW edema-which can complicate patients requiring intermaxillary fixation (IMF) in the setting of pan-facial trauma. METHODS: A modified technique was devised to assist the reconstruction surgeon in avoiding the risks associated with tracheostomy placement. In an effort to avoid surgical AW complications and improve nasal AW patency in the setting of concurrent IMF and nasal trauma, the authors developed a 2-stage technique drawing upon knowledge from the literature and the authors' own experiences. TECHNIQUE: Following safe extubation, the authors insert open lumen nasal splints in both the nostrils, and suture them together to the nasal septum. If additional inner nasal support is required, polyvinyl alcohol nonabsorbable nasal packing dressing is covered with antibiotic ointment, and then placed within the nasal cavity lateral to the open lumen splints-as a way to further bolster the internal valve and mid-vault anatomy. DISCUSSION: Given the fact that traditional nasal packing with merocele/gauze dressing in concomitant to IMF reduced patients ability to ventilate, the authors felt that a modified technique should be applied. The authors' preferred materials in such patients are open lumen splint, which provides nasal AW patency along with some septum support accompanied by merocele dressing. The authors feel that by applying this technique they achieve dual objectives by supporting the traumatized nose and maintaining nasal AW patency.

Two Suturing Techniques for the Prevention and Treatment of Nasal Valve Collapse After Mohs Micrographic Surgery.

BACKGROUND: Tumor extirpation of nonmelanoma skin cancer (NMSC) adjacent to the alar groove, using Mohs micrographic surgery (MMS), may risk causing internal nasal valve (INV) collapse, resulting in reduced airflow during inspiration. There are many surgical options described in the literature to repair INV collapse as a postoperative corrective procedure, but few exist as an intra-operative preventative procedure. OBJECTIVE: The authors present 2 distinct methods to prevent and treat INV collapse during the repair of a perialar surgical defect caused by MMS. METHODS: A 3-point stitch method or a modified suspension suture technique was used to prevent INV collapse during the repair of MMS defects overlying the alar groove, for nonmelanoma skin cancers. The 3-point stitch was used with a complex repair. The modified suspension suture was used with flap reconstruction. RESULTS: The 3-point stitch and the modified suspension suture are simple, single-stage surgical solutions for perialar defects with collapse of the INV caused by loss of subcutaneous tissue during MMS. Once executed, patients experienced immediate subjective airflow improvement which was also supported by clinical examination. Patients were followed at 1 week and at 3 months postoperatively. Thirty-four of 35 patients reported good functional and cosmetic results and were satisfied with the final outcome. CONCLUSION: The 3-point stitch and the modified suspension suture techniques are easy and simple methods that can be incorporated into reconstruction after MMS for defects of variable depth covering any multisubunit perialar region to prevent or correct INV collapse.

Effect of Spreader Graft on Nasal Functions in Septorhinoplasty Surgery.

OBJECTIVE: The authors aimed to investigate the effect of spreader grafts on nasal function in septorhinoplasty (SRP). METHODS: A prospective randomized double-blind study was conducted. Thirty patients who underwent SRP operation between October 2011 and January 2013 were divided into 2 equal groups randomly. Fifteen patients underwent SRP surgery without spreader graft technique (Group I) and 15 patients underwent SRP surgery with spreader grafts (Group II). Preoperative and postoperative evaluation included visual analog score (VAS) and acoustic rhinometry test. RESULTS: Visual analog scores and acoustic rhinometry measurements of Group I and Group II patients were compared. Statistically significant difference was found for VAS scores of both the sides of the nasal cavity (both before and after topical decongestion) (P < 0.05), except for the VAS on the right side of the nasal cavity before decongestion (P > 0.05). On acoustic rhinometry test the difference was statistically significant for minimal cross-sectional area (MCA) and volumetric values (VOL)-MCA1, MCA2, VOL1, VOL2 values on the left side of the nasal cavity (both before and after topical decongestion) (P < 0.05) but not on the right side of the nasal cavity (P > 0.05). CONCLUSIONS: Performing spreader graft technique in SRP surgery can prevent the narrowing of the internal nasal valve area after surgery and maintain adequate airway for respiration.

Reconstruction of the Intranasal Lining.

Reconstruction of full-thickness nasal defects has been the subject of surgical inquiry and innovation for over 2,000 years. The replacement of the internal nasal lining is a critical feature of complex nasal reconstruction. Successful reconstruction can prevent cicatricial contraction, external distortion, and internal stenosis. An array of reconstructive possibilities has been described, including cutaneous, mucosal, and fascial options. The challenge to the reconstructive surgeon is to select the repair that maximizes internal stability, while maintaining a patent nasal airway, minimizing morbidity, and meeting patient expectations. This article reviews the options available for the reconstruction of the intranasal lining.

[The complications of transethmoidal decompressive orbitotomy associated with endocrine ophthalmopathy]. / Oslozhneniia transétmoidal'noi dekompressionnoi orbitotomii pri éndokrinnoi oftal'mopatii.

The objective of the present study was the analysis of the results of transethmoidal decompressive orbitotomy (TEDO) with the resection of the bone matrix of the medial and inferior orbital walls in the patients presenting with endocrine ophthalmopathy (EOP) with the purpose of reduction of the risk of development of this pathological conditions. A total of 51 patient with EOP at the stage of complete remission or pharmacotherapeutic compensation underwent transethmoidal decompressive medial orbitotomy in the ENT Clinic of 1 I.M. Sechenov First Moscow State Medical University during the period from 2006 to 2016. Twenty two of these patients presented with the unilateral process and 29 ones with bilateral exophthalmos. The surgical intervention was performed on the total of 80 eye orbits. The main complaints of the treated patients during the post-operative period included difficulties in nasal breathing (33%), dryness of the nose and crust formation (43%), discharge from the nose and along the posterior pharyngeal wall (15%), nasal bleeding (2%), pain in the forehead and maxillary region (8%), headache (2%). As far as the state of eyes and sight is concerned, 14 (27%) patients reported double vision at the primary gaze position while 6 others (12%) complained of the appearance of diplopia upon a change in the gaze position during the post-operative period. The post-operative endoscopic study revealed synechiae of different localization in the nasal cavity (47%), discharge from the maxillary sinuses (16%) and from the frontal sinus (2%). Eight (16%) patients were found to suffer from maxillary sinusitis, one had acute frontitis, and one sphenoidal sinus mucocelle. These complications were eliminated by pharmacotherapy and additional surgical interventions (2%). Analysis of the results of the study has demonstrated that the above complications were associated with the inadequate post-operative care for the nasal cavity, the excessively large size of the bone window formed during transethmoidal decompressive orbitotomy, resection of the inferior orbital wall, intrusion of the medial rectus muscle of the eye into the wide bone window. We evaluated the possible influence of the orbital soft tissues on the physiological parameters of the functioning of the paranasal sinuses in the post-operative period including blockade of the paranasal drainage pathways by the prolapsed orbital tissues. A few possible approaches to the reduction of the risk of post-operative complications are proposed. The authors emphasize the importance of the further improvement of the surgical treatment of endocrine ophthalmopathy.

Role of Prostaglandin D2 and DP1 Receptor on Japanese Cedar Pollen-Induced Allergic Rhinitis in Mice.

Although we previously demonstrated the contribution of the DP1receptor in nasal obstruction using animals sensitized with ovalbumin in the presence of adjuvant, the contribution of the DP1receptor in sneezing is unclear. Here, we developed a mouse model of Japanese cedar (JC:Cryptomeria japonica) pollinosis to evaluate the symptoms of sneezing. To achieve this, we used JC pollen crude extract in the absence of adjuvant to sensitize mice to develop a model closer to the pathophysiology of human JC pollinosis. The immunologic and pharmacologic features of this model are highly similar to those observed in JC pollinosis in humans. Using this model, we found that DP1receptor antagonists suppressed JC pollen extract-induced sneezing and that a DP1receptor agonist induced sneezing. Moreover, JC pollen extract-induced sneezing was diminished in DP1receptor knockout mice. In conclusion, we developed a novel mouse model of allergic rhinitis that closely mimics human JC pollinosis. A strong contribution of DP1receptor signaling to sneezing was demonstrated using this model, suggesting that DP1receptor antagonists could suppress sneezing and nasal obstruction, and therefore these agents could be a new therapeutic option for allergic rhinitis.

Computational Fluid Dynamic Study of Nasal Respiratory Function Before and After Bimaxillary Orthognathic Surgery With Bone Trimming at the Inferior Edge of the Pyriform Aperture.

PURPOSE: This study aimed to evaluate the influence of maxillary impaction orthognathic surgery on nasal respiratory function and the efficacy of bone trimming at the inferior edge of the pyriform aperture. MATERIALS AND METHODS: The participants were 10 patients (3 male and 7 female patients) with mandibular prognathism who underwent bimaxillary orthognathic surgery with maxillary impaction. The surgical procedures performed were Le Fort I osteotomy with bone trimming at the inferior edge of the pyriform aperture and bilateral sagittal split osteotomy. Three-dimensional models of the nasal cavity were reconstructed from preoperative and postoperative computed tomography images. Furthermore, we remodeled the nasal valve region based on the postoperative models by adding a 1-mm and 2-mm stenosis to investigate the effects of bone trimming at the inferior edge of the pyriform aperture on the pressure effort. The 3-dimensional models were simulated with computational fluid dynamics, and the results of the pressure effort and the cross-sectional area (CSA) were compared for the anterior, middle, and posterior parts of the nasal cavity. The Wilcoxon signed rank test and Spearman rank correlation coefficients were used for statistical comparisons (P < .05). RESULTS: In the preoperative and postoperative models, there were considerable correlations between the CSA and the pressure effort in each part of the nasal cavity. The postoperative pressure effort showed a tendency to decrease and the CSA showed a tendency to increase in each part of the nasal cavity. In four 2-mm stenosis models, the pressure effort in the anterior nasal cavity was larger than the preoperative pressure effort and the CSA of the anterior nasal cavity was smaller than the preoperative CSA. CONCLUSIONS: Bone trimming at the inferior edge of the pyriform aperture appears to be useful for avoiding nasal respiratory complications with maxillary impaction.

The Significance of Rhinologic Evaluation and Pretreatment for Patients Undergoing Two-Jaw Surgery Through Nasotracheal Intubation.

The aim of this study is to determine whether rhinologic preoperative evaluation and pretreatments reduce intranasal trauma and decrease postoperative complications, such as nasal obstruction and epistaxis, in patients undergoing 2-jaw surgery with nasotracheal intubation. This study included 360 patients with malocclusion (Class III) who underwent 2-jaw surgery under general anesthesia via nasotracheal intubation in our hospital from January to December 2013 and categorized into 3 groups. Nasotracheal intubation was performed according to the nasal cavity the patient was able to breathe comfortably (Group I). The site of nasotracheal intubation was decided by 1 rhinologic specialist who evaluated preoperative dental computed tomography (Group II). The site of nasotracheal intubation was decided upon nasal endoscopic findings, dental computed tomography evaluation, and rhinologic pretreatment (Group III).Group II and Group III showed less damage to the nasal mucosa compared with the nasal status of Group I. Upon comparing Group II and Group III, Group III showed better overall status of the nasal mucosa compared with Group II. Visual analogue scale scores for nasal obstruction were pretty similar for all groups on the first postoperative day. In Group III, the nasal mucosa, however, was improved to that of preoperative status on the third postoperative day.In conclusion, it may be useful to pre-evaluate the mucosal and anatomical status of the nasal cavity to select patients requiring rhinologic pretreatment and decide the site for nasotracheal intubation to minimize complications arising from nasotracheal intubation.

Causes and Prevention of Secondary Obstruction.

Secondary nasal obstruction occurs when surgery fails to improve a patient's nasal obstruction symptoms. This may occur from failure to recognize a problem preoperatively or failure to address mucocutaneous medical ailments. Secondary obstruction may even occur despite perfect execution of the operative plan. In this article, we discuss the etiology, intraoperative pitfalls, and surgical correction of secondary obstruction after primary rhinoplasty. When managing postrhinoplasty secondary obstruction, care must be taken to correct the cause of obstruction without creating new problems.

Repair of nasal septal perforation using middle turbinate flap (monopedicled superiory based bone included conchal flap): a new unilateral middle turbinate mucosal flap technique.

UNLABELLED: The purpose of this study is to present a new approach for treatment of nasal septal perforation using middle turbinate flap. A consecutive study with follow-up of 31 patients with nasal septal perforation treated using middle turbinate flap. All patients underwent an endoscopic repair of nasal septal perforation using middle turbinate flap. All patients were followed for 18-24 months. Complete closure of the perforation was achieved in 29 of the 31 patients. Complete failure of the repair was observed in two patients. All patients showed nasal crusting in varying degrees for a period of 2-4 weeks. None of the patients showed nasal obstruction or atrophic rhinitis symptoms (stuffy nose, purulent postnasal drip, nasal crusting, epistaxis and anosmia) in postoperative follow-up. This technique provides a new method with many advantages compared to other techniques for closure of septal perforations. LEVEL OF EVIDENCE: IV.

Evaluating current functional airway surgery during rhinoplasty: a survey of the American Society of Plastic Surgeons.

BACKGROUND: Despite numerous reports outlining technical modifications in rhinoplasty, few publications discuss the importance of the perioperative assessment and surgical management of the nasal airway. This study's objective is to increase awareness regarding the functional aspects of rhinoplasty surgery and to encourage surgeons to incorporate functional airway management into their rhinoplasty practice. METHODS: A web-based survey was given to all members of the American Society of Plastic Surgeons (ASPS). Survey results were analysed to determine if surgeons' experience, annual rhinoplasty volume, or postgraduate training affected their results. The relationship between surgeon satisfaction with the outcome of the airway management and the frequency of performing an inferior turbinate reduction was investigated. RESULTS: Of the 4,383 listed ASPS members, 671 (21%) completed the web-based survey. Surgeons who performed a preoperative internal nasal exam were more satisfied with their results (p = 0.016) and report lower rates of postoperative nasal airway obstruction (p = 0.054). Inferior turbinate reduction did correlate to postoperative satisfaction with the nasal airway (p < 0.001). Overall, 85% of respondents were satisfied with their management of the nasal airway and 87% of respondents agreed that there is a need for more instructional courses on this topic. CONCLUSION: There is considerable variation in the results and techniques of assessment and treatment of the nasal airway. Rhinoplasty volume and inferior turbinate reduction are associated with surgeon satisfaction of management of the nasal airway. Functional airway considerations should be incorporated into routine rhinoplasty training, assessment, and treatment. LEVEL OF EVIDENCE V: This 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.

Clinically relevant effect of a new intranasal therapy (MP29-02) in allergic rhinitis assessed by responder analysis.

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.

A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis.

BACKGROUND: Moderate-to-severe allergic rhinitis (AR) is a challenge to treat, with many patients using multiple therapies and achieving limited symptom control. More effective therapies must be developed and tested in well-controlled, randomized, prospective studies with a direct comparison to current standards. OBJECTIVES: The aim of these studies was to investigate the efficacy of MP29-02 (a novel formulation of azelastine and fluticasone propionate [FP]) in patients with moderate-to-severe seasonal allergic rhinitis (SAR) and to compare its efficacy with 2 first-line therapies (ie, intranasal azelastine and intranasal FP) in this population. METHODS: Three thousand three hundred ninety-eight patients (≥12 years old) with moderate-to-severe SAR were enrolled into 3 multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trials (MP4002 [NCT00651118], MP4004 [NCT00740792], and MP4006 [NCT00883168]). Each trial was conducted for 14 days during different allergy seasons. The primary efficacy variable was the sum of the morning and evening change from baseline in reflective total nasal symptom score (range, 0-24) over the treatment period. Outcomes for the meta-analysis included efficacy according to disease severity and time to response in relevant responder criteria. RESULTS: In the meta-analysis MP29-02 reduced the mean reflective total nasal symptom score from baseline (-5.7 [SD, 5.3]) more than FP (-5.1 [SD, 4.9], P < .001), azelastine (-4.4 [SD, 4.8], P < .001), or placebo (-3.0 [SD, 4.2], P < .001). This benefit was observed from the first day of assessment, with improvement in each individual nasal symptom, even in the patients with the most severe disease. MP29-02 achieved response consistently days earlier and showed greater efficacy in patients with moderate-to-severe rhinitis than FP and azelastine. CONCLUSIONS: MP29-02 represents a novel therapy that demonstrated superiority to 2 first-line therapies for AR. Patients with moderate-to-severe SAR achieved better control, and their symptoms were controlled earlier with MP29-02 than with recommended medications according to guidelines.

A prospective randomised single-blinded clinical trial comparing the efficacy and tolerability of the nasal douching products Sterimar™ and Sinus Rinse™ following functional endoscopic sinus surgery.

OBJECTIVES: To compare the efficacy and tolerability of two commonly used nasal douching products, low-volume high-pressure Sterimar™ and high-volume low-pressure Sinus Rinse™ following functional endoscopic sinus surgery. DESIGN: Prospective randomised single-blinded study. SETTING: Tertiary referral centre. PARTICIPANTS: Thirty-one patients, undergoing functional endoscopic sinus surgery for chronic rhinosinusitis with and without polyps, were recruited for the study. The patients acted as their own comparators self-administering each douche three times daily into one randomly allocated nostril for a period of 12 weeks following the surgery. MAIN OUTCOME MEASURES: The primary outcome measure was a blinded objective endoscopic assessment of each operated side using a modified Lund-Kennedy endoscopic assessment tool undertaken at 2, 4 and 12 weeks postoperatively. As secondary outcome measures, the patients were asked to express a preference between the two products based on perceived effectiveness and ease of use. RESULTS: Compared with the preoperative scores, there was a statistically significant improvement in the SNOT-22 score at all three postoperative time points (P < 0.001). Compared with week 2, there was a statistically significant reduction in the modified Lund-Kennedy endoscopic scores (P < 0.05) for both Sterimar™ and Sinus Rinse™ at weeks 4 and 12. When comparing Sterimar™ with SinuRinse™, there was a statistically significant lower modified Lund-Kennedy score at 2 and 4 weeks postoperatively for the side treated with Sinus Rinse™ (P ≤ 0.05), indicating a more favourable outcome. However, this difference was not apparent at 12 weeks postoperatively (P = 0.66). At all time points, patients perceived Sinus Rinse™ to be more effective than Sterimar™ (P < 0.0001), but there was no significant difference in the patients' preference for either product (P > 0.05). CONCLUSION: High-volume low-pressure saline irrigation is recommended as an efficacious, easy to use and well-tolerated adjunct to endoscopic sinonasal toilet in the early postoperative period following functional endoscopic sinus surgery.