Onset-of-Efficacy of Azelastine HCl 0.15% Nasal Spray for allergic rhinitis in an environmental exposure chamber.

BACKGROUND: Azelastine nasal spray is effective in relieving symptoms of seasonal and perennial allergic rhinitis. OBJECTIVE: The objective of this single center, double-blinded, placebo-controlled, crossover study was to evaluate the time to onset of efficacy of azelastine HCl 0.15% vs placebo in participants with seasonal allergic rhinitis. METHODS: 110 participants aged 18 to 65 years were randomized to receive azelastine HCl 0.15% two sprays per nostril vs placebo nasal spray after being continuously exposed to ragweed pollen in an environmental exposure chamber (EEC). Symptoms were evaluated subjectively by the total nasal symptom score (TNSS) scale. The primary efficacy parameter was the time to onset of efficacy of azelastine as measured by the change from baseline in TNSS 15, 30, 45, 60, 90, 120, 180, and 240-minute post-dose. RESULTS: The azelastine nasal spray group had statistically significant improvement in TNSS compared with placebo 30 minutes post-dose (p=0.0002), and the effect was sustainable throughout the EEC session for all subsequent time points (p<0.0001). Adverse events were mild, including bitter taste, nasal discomfort, epistaxis, sinusitis, and nausea. No major adverse events were reported during the study. CONCLUSION: Azelastine HCl 0.15% nasal spray relieves nasal symptoms associated with allergic rhinitis and has a fast onset of action within 30 minutes. The overall safety profile of azelastine has also been proven to be safe. These results, along with prior findings on efficacy and improved quality of life for people suffering from allergic rhinitis, establish the important clinical role of azelastine HCl 0.15%.

Long-term efficacy and safety of omalizumab for nasal polyposis in an open-label extension study.

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) frequently remains uncontrolled despite maximal medical therapy and sinonasal surgery, presenting several unmet needs and challenges. Omalizumab previously demonstrated efficacy in CRSwNP in duplicate phase 3, randomized, placebo-controlled trials (POLYP 1, POLYP 2). OBJECTIVE: This open-label extension evaluated the continued efficacy, safety, and durability of response of omalizumab in adults with CRSwNP who completed POLYP 1 or 2. METHODS: After 24 weeks of omalizumab or placebo in POLYP 1 and 2, patients (n = 249) received open-label omalizumab plus background nasal mometasone therapy for 28 weeks and were subsequently followed for 24 weeks after omalizumab discontinuation. Efficacy end points assessed change from baseline for the coprimary end points, Nasal Polyp Score and Nasal Congestion Score, and the secondary end points of Sino-Nasal Outcome Test 22, Total Nasal Symptom Score and its components, and University of Pennsylvania Smell Identification Test scores. Safety objectives included incidence of adverse events and adverse events leading to omalizumab discontinuation. RESULTS: Patients who continued omalizumab experienced further improvements across coprimary end points and secondary end points through 52 weeks. Patients who switched from placebo to omalizumab experienced favorable responses across end points through week 52 that were similar to POLYP 1 and 2 at week 24. After omalizumab discontinuation, scores gradually worsened over the 24-week follow-up, but remained improved from pretreatment levels for both groups. The safety profile was similar to previous reports. CONCLUSIONS: The efficacy and safety profile from this study supports extended omalizumab treatment up to 1 year for CRSwNP with inadequate response to nasal corticosteroids.

Nocturnal nasal congestion is associated with uncontrolled blood pressure in patients with hypertension comorbid obstructive sleep apnea.

OBJECTIVE: To determine the independent role of nasal obstruction on blood pressure (BP) control in patients with hypertension comorbid obstructive sleep apnea (OSA). SUBJECTS AND METHODS: This cross-sectional study comprised of 326 newly diagnosed OSA comorbid hypertension patients from March 2018 to December 2021. Sixty-six patients have controlled hypertension, two hundred and nine with uncontrolled hypertension and fifty-one with resistant hypertension. Information on demographic characteristics, sleep data, hypertension status was collected. Multivariate logistic regression models were used to determine the odds ratios (OR). RESULTS: Patients with nocturnal nasal congestion had more difficult to control blood pressure, with more numbers of antihypertensive drugs. They tended to have more severe OSA, lower nocturnal oxygen saturation and more severe sleepiness. Univariate analysis showed that nocturnal nasal congestion and Nasal Obstruction Symptom Evaluation (NOSE) Scale scores were associated with uncontrolled BP. After adjusting for age, sex, smoking, alcohol use, OSA severity and CT90, multivariate logistic analysis models showed that nocturnal nasal congestion was independently associated with uncontrolled hypertension (OR = 2.09, p = 0.023). When analyzed more severe resistant hypertension, nocturnal nasal congestion showed a higher association (OR = 2.96, p = 0.014). CONCLUSION: This cross-sectional study demonstrated that the nocturnal nasal congestion was independently associated with uncontrolled BP. The use of nasal decongestants or nasal surgery may be a potential therapeutic target for resistant hypertension in the future.

Effectiveness of intranasal steroids on rhinitis symptoms, sleep quality, and quality of life in patients with perennial allergic rhinitis.

PURPOSE: Evaluate the impact of perennial allergic rhinitis (PAR) on the health-related quality of life (HRQL) and measure performance issues that are of major concerns for PAR patients, as well as determining the effect of intra-nasal steroids (INS) on PAR and associated congestion, sleep complaints, and daytime sleepiness. METHODS: This study was a cross-sectional study. A total of 78 PAR patients underwent otorhinolaryngological examination and skin test. All participants filled in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ), the Stanford Sleepiness Scale (SSS), and the Epworth Sleepiness Scale (ESS). Participants were asked to undergo treatment with Budesonide (BUD) topical aqueous nasal spray for eight weeks. After the treatment period, all participants were again asked to answer the three questionnaires. RESULTS: The results of this study found statistically significant improvements in the overall NRQLQ score (p < 0.001) and individual NRQLQ domain scores (p < 0.05) after INS treatment. A statistically significant reduction in symptom severity in the four NRQLQ domains before and after treatment was found (p < 0.05), except for restlessness, post-nasal drip, and avoiding symptom triggers (p = 0.575, 0.172, and 0.705, respectively). There was a statistically significant difference in ESS and SSS scores before and after treatment (p < 0.001). CONCLUSION: PAR has a significant impact on sleep quality and, as a result, a lower QOL. This study demonstrates that INS is an effective modality in the treatment of PAR and positively impacts patients' QOL by improving nasal symptoms, daytime fatigue, and somnolence, and sleep quality.

[Subjective assessment of the effect of septoplasty on respiratory and voice functions]. / Sub"ektivnaya otsenka vliyaniya septoplastiki na dykhatel'nuyu i golosovuyu funktsii.

OBJECTIVE: To assess the impact of septoplasty on quality of life by measuring changes in nasal breathing and voice function using subjective assessment questionnaires. MATERIAL AND METHODS: The study included 98 patients who underwent septoplasty for the nasal septum deviation. The effect of the operation on nasal breathing was assessed subjectively using the Nasal Obstruction Septoplasty Effectiveness (NOSE) questionnaire, and the effect on voice function was assessed using the Voice Handicap Index-30 (VHI-30) questionnaire. RESULTS: There was a statistically significant difference between the preoperative and postoperative (after 1 and 3 months) NOSE data (in both cases, p<0.001) and and between the indicators 1 and 3 months after surgery (p<0.001). There was a statistically significant difference (p<0.001 in both cases) between the preoperative VHI-30 and 1 and 3 months postoperatively. There was also a statistically significant difference (p<0.001) between 1 and 3 months after surgery for this test. CONCLUSION: In this study, the effect of septoplasty on respiratory and voice function was demonstrated using subjective tests. In the postoperative period, patients subjectively positively assessed changes in both nasal breathing and voice.

Intranasal epinephrine effects on epinephrine pharmacokinetics and heart rate in a nasal congestion canine model.

BACKGROUND: Histamine release and vasodilation during an allergic reaction can alter the pharmacokinetics of drugs administered via the intranasal (IN) route. The current study evaluated the effects of histamine-induced nasal congestion on epinephrine pharmacokinetics and heart rate changes after IN epinephrine. METHODS: Dogs received 5% histamine or saline IN followed by 4 mg epinephrine IN. Nasal restriction pressure, epinephrine concentration, and heart rate were assessed. Maximum concentration (Cmax), area under plasma concentration-time curve from 1 to 90 min (AUC1-90), and time to reach Cmax (Tmax) were measured. Clinical observations were documented. RESULTS: In the 12 dogs in this study, nasal congestion occurred at 5-10 min after IN histamine administration versus no nasal congestion after IN saline. After administration of IN epinephrine, IN histamine-mediated nasal congestion was significantly reduced to baseline levels at 60, 80, and 100 min. There were no significant differences in Cmax and AUC1-90 between histamine and saline groups after IN epinephrine delivery (3.5 vs 1.7 ng/mL, p = 0.06, and 117 vs 59 ng/mL*minutes, p = 0.09, respectively). After receiving IN epinephrine, the histamine group had a significantly lower Tmax versus the saline group (6 vs 70 min, respectively; p = 0.02). Following IN epinephrine administration, the histamine group showed rapidly increased heart rate at 5 min, while there was a delayed increase in heart rate (occurring 30-60 min after administration) in the saline group. Clinical observations included salivation and emesis. CONCLUSION: IN histamine led to more rapid epinephrine absorption and immediately increased heart rate compared with IN saline. IN epinephrine decreased histamine-induced nasal congestion.

Office-based inferior turbinate reduction using bipolar cautery: Technique and results.

OBJECTIVES: Several methods have been reported for inferior turbinate (IT) reduction. We describe office-based interstitial IT reduction using bipolar cautery and evaluate long-term efficacy. METHODS: Sixty patients with allergic and nonallergic rhinitis unresponsive to medical treatment underwent office IT reduction between January 2012 and December 2014. Bipolar cautery was used at 15 to 20 W. Mean procedure time was 12 min for unilateral and 16 min for bilateral IT reduction. Patients followed up at 2, 6, and 12 weeks and 1 year. Mean follow-up was 22 months. The Sinonasal Outcome Test was completed before and after at 6 weeks and 1 year. RESULTS: SNOT-22 scores were 35.7 ± 5.4 and 18.5 ± 4.2 preoperatively and at 1 year respectively. Symptoms improved at 6 weeks, nasal obstruction and rhinorrhea improving most. Complications included vaso-vagal reactions in 6 requiring rescheduling the procedure in 2 patients. One patient had bleeding controlled conservatively. CONCLUSION: Bipolar IT cautery is safe, effective, well-tolerated and doesn't require expensive equipments. It can be incorporated into general otolaryngology practice.

[Rhinitis medicamentosa]. / Lekarstvenno-indutsirovannyi rinit.

One type of non-allergic non-infectious rhinitis is represented by a heterogeneous group of rhinitis medicamentosa, which can be divided into several pathogenetic types. The most common rebound nasal congestion associated with the use of topical decongestants. Excessive use of intranasal decongestants leads to a decrease in the number of alpha-adrenoreceptors on the surface of cell membranes and uncoupling their connection with the G-protein and the development of tachyphylaxis. To prevent the development of rebound nasal congestion caused by topical decongestants, it is important to limit the frequency of their use. In most cases, the duration of the use of vasoconstrictor drugs should be limited to 5-7 days, according to Patient information leaflets for the drugs. However, in patients who have had a history of episodes of rebound nasal congestion, which develops including the previously indicated periods, the duration of decongestant therapy should be limited to 3 days. Rhinitis associated with local inflammation is caused by the intake of acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs. Currently, the so-called "aspirin triad" is well known - a combination of bronchial asthma, rhinosinusitis (often polyposis) and intolerance to ASA. Neurogenic rhinitis develops due to the use of drugs that violate vascular tone, for example, antihypertensive drugs or type 5 phosphodiesterase inhibitors. Drug-induced rhinitis has a significant impact on the patient's quality of life: nasal congestion, rhinorrhea, secondary night apnea, insomnia as a result of nasal breathing disturbances, headaches, irritability, weakness after sleepless nights disturb patients to a large extent. Timely diagnosis and withdrawal of a provocative drug, the use of topical corticosteroids in case of severe rhinitis are the basis of the treatment of rhinitis medicamentosa. In severe cases, there is a need, including surgical treatment, such as, for example, submucosal laser destruction of the lower nasal concha.

[Innovative technology full volume lavage of the nasal cavity in the treatment of allergic and vasomotor rhinitis]. / Innovatsionnye tekhnologii polnogo ob''emnogo promyvaniia polosti nosa v lechenii allergicheskogo i vazomotornogo rinitov.

Viewed 60 men and women (mean age 26.2±2.4 years) with rhinitis, including: 30 people (18 women and 12 men) 20-45 years with verified diagnoses of persistent allergic rhinitis and 30 patients (16 males and 14 females) 18-35 years (mean age 22.5±1.7 years) - neurovegetative form of chronic vasomotor rhinitis in the phase of exacerbation, receiving basic therapy with antihistamines of the II generation, stabilizers of membranes of mast cells and decongestants, divided by random sampling into 4 groups: 1A (20 patients with allergic rhinitis) and 2A (20 patients with vasomotor rhinitis) were received within 30 days in addition to the basic therapy of the nasal cavity washing procedure with the device Dolphin; in the groups 1B (10 patients with allergic rhinitis) and 2B (10 patients with vasomotor rhinitis) only basic treatment was carried out. By the end of the treatment course, the severity of the symptom 'difficulty in nasal breathing' in patients in groups 1A and 2A, decreased 2.6 times and met the criterion of 'minor violation', while in groups 1B-decreased only 1.3 times, and in 2B-changes were not significant and corresponded to 'moderate violation'. Manifestations of rhinorrhea after therapy decreased in the group of 1A 2.0 times, and in the group of 2A 1.7 times, which was regarded as' a slight manifestation of the symptom', whereas in the groups of 1B and 2B only a tendency to improve was revealed. At the end of the follow - up period, the severity of the symptom 'sneezing' decreased in patients in group 1A by 4.0 times, in group 2A-3.3 times and corresponded to 'no disturbance', while in groups 1B and 2B changes were less than 3.0 and 2.7 times respectively. At the end of the treatment course in patients in groups 1A sense of smell was restored in the group 2A -the degree of severity of olfaction decreased 3.0 times, while in the group of 1B-only 1.2 times, and in the group of 2B-has not changed. According to the visual analog scale (VAS), on the background of treatment optimized by nasal lavage with the device Dolphin complex, the greatest decrease in the degree of violations of household activity was revealed in patients with allergic rhinitis - 2.9 times. After treatment, the effect of rhinitis symptoms on sleep disturbance decreased in groups 1A and 2A 1.9 times, while in groups 1B and 2B - only 1.3 times. The use of nasal lavage with device Dolphin complex in the treatment of allergic and vasomotor rhinitis contributed to a decrease in the frequency of use of intranasal vasoconstrictive drugs by the 10th day of observation by 1.8 and 1.6 times, respectively, and by the 15th day-by 2.3 and 2.4 times, respectively. In the groups of standard treatment (1B and 2B) revealed a significant reduction in the frequency of decongestants was observed only after 15 days of treatment. Thus, the inclusion of a full volumetric nasal lavage with the device Dolphin complex in the treatment of patients with persistent allergic and neurovegetative form of chronic vasomotor rhinitis contributes to the reduction of clinical simtomatics, reduces the severity of violations of everyday life and the frequency of decongestants, improves night sleep of patients.

Comparison of outcome measures in allergic rhinitis in children, adolescents and adults.

BACKGROUND: Grass pollen-induced allergic rhinoconjunctivitis (AR) is very common worldwide. However, its symptoms may vary with the patient's age. The present study compared symptom profiles and quality of life (QoL) in children, adolescents and adults with grass pollen-induced AR. METHODS: This was a four-week, multicentre, observational study of children (aged 6-11), adolescents (12-17) and adults (18-65) consulting specialist physicians in France. The management of AR was at the physicians' discretion. Participants regularly rated their symptoms (the rhinoconjunctivitis total symptom score (RTSS) and a visual analogue scale (VAS)) and QoL (the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RESULTS: A total of 806 patients (253 children, 250 adolescents and 303 adults, of whom 83.5% suffered from moderate-to-severe, persistent AR) provided data for at least the first 2 weeks of the study. Ocular pruritus (the most bothersome symptom in children (35%), adolescents (22%) and adults (16%)) was associated with poor QoL in all groups, whereas nasal obstruction and pruritus were associated with poor QoL in adolescents and children. Over 4 weeks, the weekly mean RTSS and VAS scores fell by around half. This change was associated with an improvement in the RQLQ scores. In all age groups, the VAS score was well correlated with the weekly mean RTSS score (Pearson's r: 0.79-0.88) and moderately correlated with the weekly mean RQLQ score (Pearson's r: 0.64-0.80). CONCLUSIONS: In moderate-to-severe grass pollen-induced AR, symptom perception differs in children vs. older patients. However, the assessments of treatment outcomes (using the RTSS, VAS and RQLQ) were similar in all age groups.

The discovery of quinoline based single-ligand human H1 and H3 receptor antagonists.

A novel series of potent quinoline-based human H1 and H3 bivalent histamine receptor antagonists, suitable for intranasal administration for the potential treatment of allergic rhinitis associated nasal congestion, were identified. Compound 18b had slightly lower H1 potency (pA2 8.8 vs 9.7 for the clinical goldstandard azelastine), and H3 potency (pKi 9.1vs 6.8 for azelastine), better selectivity over α1A, α1B and hERG, similar duration of action, making 18b a good back-up compound to our previous candidate, but with a more desirable profile.

The nasal vestibular body: anatomy, clinical features, and treatment considerations.

Nasal obstruction is a common presenting complaint, with many possible etiologies. Herein, we provide an introductory anatomic description, clinical relevance, and proposed nomenclature for an underappreciated soft tissue focus in the nasal vestibule-the nasal vestibular body (NVB)-that can contribute to nasal obstruction in a subset of patients. This is a small mound of dynamic soft tissue in the lateral aspect of the internal nasal valve, situated inferior and anterior to the head of the inferior turbinate that can be missed on routine examination for many salient reasons. In well-selected patients, whose symptoms of nasal obstruction may in part be secondary to the presence of this soft tissue focus, directed testing and tissue reduction can be performed.

Pregnancy rhinitis in Turkish women: Do gestational week, BMI and parity affect nasal congestion?

OBJECTIVE: To determine the cumulative incidence of pregnancy rhinitis along with prevalence in different trimesters and to find out whether gestational age, BMI and parity have any effect on pregnancy related nasal congestion. METHODS: In the prospective protocol at the obstetrics outpatient clinic, 167 pregnant women were enrolled consecutively. According to exclusion criteria, 67 of them were excluded. Visual-Analogue-Scale (VAS), Nasal-Obstructive-Symptom-Evaluation (NOSE) scale and Discharge-Inflammation-Polyps/Oedema (DIP) scoring were utilized for diagnosis of pregnancy rhinitis. Besides, weight, length, age, parity and week of pregnancy were recorded. RESULTS: Total prevalence of pregnancy rhinitis was 17.17% and cumulative incidence was 38.89%. Our study revealed significant relation of NOSE score with both gestational week (r=0.474, p=0.001) and BMI (r=0.301, p=0.003). VAS score was significantly related with gestational week (r=0.409, p=0.001) and BMI (r=0.270, p=0.007). DIP score was found to be correlated only with gestational week (r=0.375, p=0.001). CONCLUSION: Cumulative incidence of pregnancy rhinitis was 38.89%. Nasal congestion was significantly associated with BMI and gestational week. Patients should be informed about unfavorable fetal and maternal outcomes of pregnancy related nasal congestion which is triggered by obesity and excessive weight gain in pregnancy.

Successful management of unilateral nasal vestibular stenosis caused by trauma: A case report.

INTRODUCTION: Nasal vestibular stenosis is a rare trauma-related nasal congestion. PRESENTATION OF CASE: A 52-year-old man complained of right nasal obstruction for 2 weeks caused by hot metal fragments from a gas cylinder explosion 7 weeks before. The patient was diagnosed with right nasal vestibular stenosis due to nasal trauma based on physical examination and CT scan. The patient underwent right nasal vestibular stenosis repair for 2 h without complications. The patient was positioned with the head elevated 20° and received IVFD RD5 therapy at a rate of 1500 mL/day, ceftriaxone 2 × 1 g/day, metamizole 3 × 1 g/day, and ranitidine 2 × 50 mg/day. On the second day, there was no bleeding, pain, or nasal congestion, and an anterior rhinoscopy showed a silicone tube in place. The patient was discharged the same day and started on oral cefixime 2 × 200 mg/day, gentamicin ointment and nasal saline irrigation (NSI) 2 × 100 mL/day for both nostrils. Three months after surgery, the septal stitches and silicone tube were removed and no bleeding was found. DISCUSSION: The management of vestibular stenosis caused by trauma has a higher success rate than other types of vestibular stenosis. Prompt management plays a crucial role in successfully treating unilateral vestibular stenosis caused by trauma. CONCLUSION: Prompt management is highly effective in treating unilateral vestibular stenosis.

Lipoma Arising in the Eustachian Tube.

Lipomas are among the most common soft tissue tumors. Surgical removal of lipoma is considered if the patient has symptoms or cosmetic challenges. Lipomas that develop from any fat tissue in the body and involve the eustachian tube are extremely rare. Herein, we report the case of a patient with a lipoma arising in the eustachian tube. We also summarized the literature on tumors originating from the eustachian tubes. A 62-year-old female presented to our department with a five-year history of left nasal congestion. Nasal endoscopy revealed a tumor in the left eustachian tube. The tumor was considered a lipoma on computed tomography (CT) and magnetic resonance imaging (MRI) and was removed using a transnasal endoscopic approach. Nasal endoscopy and radiologic imaging can be used to detect tumors in the nasopharynx, including the eustachian tubes. Magnetic resonance imaging is particularly useful for the diagnosis of lipomas. A lipoma in the eustachian tube can cause nasal congestion and aural fullness, and the transnasal endoscopic approach is useful for tumor removal.

Features of Importance in Nasal Endoscopy: Deriving a Meaningful Framework.

OBJECTIVE: Critical components of the nasal endoscopic examination have not been definitively established for either the normal examination or for clinical disorders. This study aimed to identify concordance among rhinologists regarding the importance of examination findings for various nasal pathologies. STUDY DESIGN: A consortium of 19 expert rhinologists across the United States was asked to rank the importance of findings on nasal endoscopy for 5 different sinonasal symptom presentations. SETTING: An online questionnaire was distributed in July 2023. METHODS: The questionnaire utilized JotForm® software and featured 5 cases with a set of 4 identical questions per case, each covering a common indication for nasal endoscopy. Rankings were synthesized into Normalized Attention Scores (NASs) and Weighted Normalized Attention Scores (W-NASs) to represent the perceived importance of each feature, scaled from 0 to 1. RESULTS: General concordance was found for examination findings on nasal endoscopy within each case. The perceived features of importance differed between cases based on clinical presentation. For instance, in evaluating postnasal drip, the middle meatus was selected as the most important structure to examine (NAS, 0.73), with mucus selected as the most important abnormal finding (W-NAS, 0.66). The primary feature of interest for mucus was whether it was purulent or not (W-NAS, 0.67). Similar analyses were performed for features in each case. CONCLUSION: The implicit framework existing among rhinologists may help standardize examinations and improve diagnostic accuracy, augment the instruction of trainees, and inform the development of artificially intelligent algorithms to enhance clinical decision-making during nasal endoscopy.

Unilateral Choanal Atresia in a Child With Prolonged Nasal Congestion.

Choanal atresia obstructs the nasal passage due to abnormal bony or soft tissue remnants owing to the faulty canalization of the nasal passages during fetal development. The clinical manifestations are more pronounced in bilateral cases, often presenting immediately after birth with cyanosis turning pink when crying, as newborns are obligatory nasal breathers. This contrasts in unilateral cases, where the condition may present with mild symptoms and be diagnosed later in life. We present a case of a five-year-old male who initially presented with a concern for nasal polyps due to nasal congestion with absent airflow out of the right nostril. On examination of the pharynx and nose, the patient was diagnosed with nasal turbinate hypertrophy, the right more than the left, and was subsequently scheduled for bilateral inferior turbinate reduction, possible adenoidectomy, and nasal endoscopy. Intraoperatively, inspection with nasal endoscopy along with the inability to pass a catheter through the nasopharynx to reach the oropharynx was our indicator of a more severe diagnosis. Here, we report an incidental finding of the right choanal atresia and seek to highlight its importance given this incidental finding.

A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold.

BACKGROUND: The common cold is a frequent, acute, and mild upper respiratory human disease. Nasal congestion has been considered the most bothersome symptom in the common cold, impacting quality of life (QoL). Topical decongestants containing steroids benefit QoL in allergic rhinitis, but no published research has assessed the impact of topical decongestants on QoL in the common cold. OBJECTIVE: To evaluate the effects of xylometazoline hydrochloride 0.1% (Otrivin, GSK Consumer Healthcare SARL, Switzerland) for up to 7 days on QoL in participants with nasal congestion associated with the common cold. DESIGN: This was a decentralized, longitudinal, open-label study. METHODS: The study enrolled 136 participants (⩾18 years) with early symptoms of the common cold, of which 102 were included in the modified intention-to-treat (mITT) population. Within 24 h of study product receipt, participants confirmed a 'plugged nose' and ⩾1 other common cold symptom. Primary endpoints were Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) total score, total and individual symptom scores, and total QoL score. Secondary endpoints were additional QoL scores. Exploratory and post hoc analyses included median days to resolution for each QoL factor and analyses of five QoL categories. RESULTS: Consistent improvements in symptoms and QoL were seen in the mITT population. From day 1, improvements were seen in the 'plugged nose' symptom (p = 0.0023), WURSS-21 total QoL score, and all individual QoL scores (p < 0.0001 for all). After the last dose needed, significant improvements were seen in sleep quality (73%), vitality (76%), physical activity (71%), social activity (80%), and sensation (81%). No serious or unexpected adverse events were reported. CONCLUSION: This study is the first to demonstrate in a real-life setting that treating nasal congestion in adults with xylometazoline hydrochloride 0.1% during the common cold positively impacts QoL factors relevant to daily living [Otrivin: Quality of Life (QoL) Impact in a Real-World Setting; https://clinicaltrials.gov/study/NCT05556148].

Impact of xylometazoline hydrochloride 0.1% on quality of life in people with blocked nose associated with the common coldThe common cold is a widespread, mild respiratory illness for which a hallmark symptom is a blocked or stuffy nose, which makes breathing and sleeping difficult. This study focused on how a nasal spray called Otrivin (containing xylometazoline hydrochloride 0.1%) impacts the quality of life (QoL) of people suffering from nasal congestion due to the common cold.Participants answered a questionnaire called the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21), which helped understand how people experience respiratory symptoms and how different aspects of QoL were impacted. Participants also responded to eight additional QoL questions not covered in the WURSS-21.The results showed that from the first day of using the nasal spray, participants experienced significant relief from the blocked nose symptom and reported an overall improvement in their QoL and well-being, such as in sleep quality, energy levels, senses, and physical and social activities.In conclusion, this real-world study demonstrated that using xylometazoline hydrochloride 0.1% nasal spray during the common cold can significantly improve nasal congestion and various aspects of a person's daily life. These findings provide valuable evidence for using this nasal spray to relieve symptoms and enhance the overall well-being of individuals with the common cold.

Acute Effects of Exercise at Different Temperatures on Clinical Symptoms and Nasal Blood Flow in Patient with Allergic Rhinitis: A Randomized Crossover Trial.

Allergic rhinitis (AR) affects the nose and is triggered by allergens. However, no research studies have analyzed the acute effect of aerobic exercise at different temperatures in AR patients. This study was to determine the acute effect of aerobic exercise at different temperatures on rhinitis symptoms and nasal blood flow (NBF) in AR patients. Fifteen AR patients aged 18-24 years were randomized in a crossover fashion into two protocols: 60 minutes of aerobic exercise at temperatures of 25 °C and 34 °C. The NBF, rhinitis symptoms, peak nasal inspiratory flow (PNIF), fractional exhaled nitric oxide (FeNO) and oxygen saturation (SpO2) variables were measured. During exercise at 25°C, a notable reduction was observed in NBF, nasal congestion, and sneezing in comparison to exercising at 34°C (p < 0.05). The SpO2 demonstrated significant decreases at 34°C compared to exercise at 25°C after 30 minutes post exercise. The rhinitis symptom scores and NBF in both exercise at 25°C and 34°C significantly decreased and PNIF increased during and after exercise compared to before exercise (p < 0.05). In conclusion, both exercising at 25°C and 34°C can contribute to the alleviation of allergic rhinitis symptoms by decreasing rhinitis symptom and NBF. However, exercising in a room at 25°C exhibits a more significant reduction in nasal blood flow, nasal congestion, and sneezing compared to the 34°C setting.

Efficacy of tympanostomy tube placement with adjuvant adenoidectomy in children less than 4 years of age.

OBJECTIVE: About 8.6 % of children in the United States undergo tympanostomy tube (TT) placement every year. Of these, 24.1 % require a second set of tubes. Adjuvant adenoidectomy in children over 4 years is thought to improve the efficacy of TT. The goal of this study is to characterize the efficacy of adjuvant adenoidectomy at the time of TT placement in children under 4 years, to further improve middle ear function. METHODS: All patients undergoing TT placement alone or TT placement with adenoidectomy from 2014 to 2016 were reviewed. The primary outcome was need for subsequent tube placement. RESULTS: A total of 409 patients were included in the study (60.6 % male, 39.4 % female). Median age at initial TT placement was 18 months (range 5-48 months); extreme outliers for age were removed from further analysis. Patients were followed for 1-8 years. 250 patients received TT alone while 159 received TT with adenoidectomy. 120 required a second set of tubes. There was a statistically significant benefit to those undergoing adjuvant adenoidectomy with TT placement: 33.6 % of those receiving TT alone required subsequent tubes, whereas only 22.6 % of patients who underwent TT with adjuvant adenoidectomy required reinsertion (X2 = 5.630, p = 0.018). Adjuvant adenoidectomy in patients 0-48 months was associated with decreased likelihood of requiring subsequent tube placement (OR = 0.578, p = 0.018). There was an increased likelihood of experiencing otorrhea in those receiving TT alone compared to the TT with adenoidectomy group (X2 = 4.353, df = 1, p = 0.0369). CONCLUSION: Adjuvant adenoidectomy at the time of initial TT placement may have a role in the management of chronic middle ear disease in patients younger than 4 years. However, further studies and prospective randomized studies are needed to explore if this benefit can also be seen in children without chronic rhinosinusitis or nasal obstruction. The benefit-risk ratio from adenoidectomy and modifications in anesthesia technique in the case of adjuvant adenoidectomy should also be further explored.