Fluticasone Propionate Nasal Spray Research Articles

Simultaneous HPLC method development for azelastine HCl and fluticasone propionate nasal spray formulation

Abstract: Azelastine HCl and Fluticasone Propionate nasal spray drug product is commonly used to treat moderate to severe allergic rhinitis and rhino-conjunctivitis. To date, a simultaneous HPLC method for active sub-stances and impurities of this product has not been reported. Acetonitrile and buffer (Octane-1-Sulfonic Acid Sodium Salt and Potassium Dihydrogen Phosphate) were used as a mobile phase. The separation was achieved using Phenomenex Phenyl-hexyl (150 cm × 4.6 mm, 5 µm) column at 1 mL/min flow rate in gradient elution mode. The chromatograms were monitored at 240 nm. The validation parameters such as linearity, limit of quantification, limit of detection, accuracy, precision, robustness and specificity were investigated for the nasal spray. Overall, this study provides valuable insights into the development and validation of an efficient analytical method for assessing the quality and stability of a combination of Azelastine HCl and Fluticasone Propionate nasal spray.

Quantification of fluticasone propionate in human plasma by LC–MS/MS and its application in the pharmacokinetic study of nasal spray at clinical doses

We developed a method for quantifying fluticasone propionate (FP) using general-purpose liquid chromatography–tandem mass spectrometry equipment to measure the plasma concentration of FP for the pharmacokinetic study of FP following the administration of a prescribed nasal spray dose (100 μg). Using ammonium acetate (0.01 M)–formic acid (pH 2.9; 499:1, v/v) and methanol as the mobile phase, 3 pg/mL of FP was quantified. The relative error and standard deviation of the lower limit of quantification were <3.1%. The intra- and interday assay reproducibility was <3.5%. After 15 min of administering 200 μg FP nasal spray as the first dose, the FP concentration detected in the plasma of the two participants was 3.99 and 3.69 pg/mL. Subsequent doses of 100 μg FP were administered twice daily. The area under the plasma concentration–time curve values after 8–10 days of repeated administration of 100 μg of FP were approximately 1.6-fold higher than those achieved following a single administration of 200 μg of FP, which confirmed drug accumulation. The bioavailability of nasal FP was estimated to be 2% and 4%. This knowledge might help in reducing anxiety among patients who avoid using FP nasal spray, fearing its adverse effects.

A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis.

The objective of the present study was to evaluate the efficacy and safety of MP-AzeFlu nasal spray in comparison to commercially available azelastine hydrochloride and fluticasone propionate sprays in Chinese patients with moderate-to-severe allergic rhinitis (AR). We conducted a 14-day multicenter, randomized, double-blind, active controlled prospective clinical study in adult and adolescent patients with AR, who had moderate-to-severe symptoms. The primary efficacy endpoint was the change from baseline in combined 12-h reflective total nasal symptom score (rTNSS) (morning [AM] + afternoon [PM]). The safety profile of the study medications was assessed through the recording, reporting, and analysis of baseline medical conditions, adverse events (AEs), vital signs, and focused nasal examination. Three hundred patients per treatment group were randomized, which led to a total sample size estimation of 900 patients. MP-AzeFlu group showed significantly higher symptom reduction for the entire 2-week treatment period in rTNSS when compared with the AZE group (LS mean difference: -1.96; 95% CI: - 2.53, - 1.39; p < 0.0001), or the FLU group (LS mean difference: -0.98; 95% CI: - 1.55, - 0.41; p = 0.0007). The results of adult RQLQ showed improvement in QoL in all treatment groups. Except for dysgeusia (bitter taste) that was reported by more patients (13 [4.3%]) in the MP-AzeFlu group, the incidence of all other TEAEs in the MP-AzeFlu group was comparable or even lower than in other treatment groups. MP-AzeFlu, when administered as one spray per nostril twice daily for 14days, alleviated AR symptoms in Chinese patients with moderate-to-severe AR. Clinicaltrials.gov; NCT03599791, Registered June 29, 2018, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03599791 .

[Observation of the long-term clinical efficacy of "Fuyang Guben" acupuncture-moxibustion therapy on perennial allergic rhinitis and its effects on the total IgE and IL-4 in the serum].

To investigate the long-term clinical efficacy and safety of "Fuyang Guben" (supporting yang and consolidating root) acupuncture-moxibustion therapy on perennial allergic rhinitis (PAR), and to explore its functioning mechanism. The patients with PAR were randomly divided into acupuncture + western medicine group (n=30) and western medicine group (n=30). In the western medicine group, fluticasone propionate nasal spray was administered, one spray in each nostril in one treatment, once a day, for 6 weeks. On the basis of the western medicine group, fuyangguben acupuncture-moxibustion therapy was supplemented. Acupuncture was applied to Shangxing (GV23), Yintang (GV24+), and bilateral Yingxiang (LI20), Shangyingxiang (EX-HN8), Sibai (ST2), Hegu (LI4) and Chize (LU5); warm needling was applied at Dazhui (GV14). The patients of this group received 30 min of acupuncture-moxibustion therapy 3 times weekly during the first 4 weeks and twice a week in the last 2 weeks, totally for 6 weeks. Before treatment, after treatment, in week 10, 18 and 30 of follow-up visits, the reflective total nasal symptom score (rTNSS), the total non-nasal symptom score (TNNSS), the total ophthalmic symptom score (TOSS), and the score of the rhinitis quality of life (RQLQ) scale were compared in the patients of the two groups separately. Using ELISA, the serum concentrations of total immunoglobulin E (IgE) and interleukin-4 (IL-4) were detected before and after treatment. After treatment, the rTNSS, TNNSS, TOSS, as well as RQLQ score were lower in comparison with those before treatment in each group (P<0.05).The rTNSS, TNNSS, TOSS and the score of RQLQ in the week 10, 18 and 30 of follow-up visits were reduced when compared with those before treatment in each group (P<0.05), and these scores in the acupuncture + western medicine group were remarkably lower than those of the western medicine group (P<0.05). After treatment, the serum contents of total IgE and IL-4 were significantly decreased when compared with those before treatment in the acupuncture + western medicine group (P<0.05), and these indicators in the acupuncture + western medicine group were lower than those of the western medicine group (P<0.05). On the base of treatment with fluticasone propionate nasal spray, "Fuyang Guben" acupuncture-moxibustion therapy is safe and effective on PAR, presenting a remarkably long-term efficacy. The functioning mechanism may be related to the down-regulation of total IgE and IL-4 in serum.

Effects of oral prednisolone and fluticasone nasal spray in the management of chronic rhinosinusitis with polyposis: A prospective observational study

To study the effects of combination therapy with oral prednisolone and topical fluticasone propionate nasal spray in patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). To study the improvement in symptom scores, Endoscopic and CT scores before and after treatment with combination therapy.This prospective observational study was conducted on 50 patients attending the Outpatient Department of Otorhinolaryngology, J.L.N Hospital and Research Centre, Bhilai (Chhattisgarh), India over a period of 6 months from February 2020 to July 2020. Patients with symptoms of CRSwNP persisting for more than 12 weeks were thoroughly examined clinically along with Nasal endoscopy and Computed Tomography scan of Nose and Paranasal sinuses (CT PNS) and pre-treatment Visual Analog Scale (VAS), Lund &amp; Mackay Scores for Endoscopic and CT findings were noted. Patients were treated with combination therapy of oral prednisolone and fluticasone propionate nasal spray and post treatment scores were noted using similar scales during the follow up visits and the results were statistically analysed.Total mean age of patients suffering from CRSwNP in our study was 47.3 ± 12.58. Males were affected more by CRSwNP than females (76% vs 24%). At the end of 3 months from baseline 48 patients (96%) showed a reduction in nasal discharge, 47 patients (94%) showed a reduction in nasal obstruction, 25 patients (50%) showed improvement in facial pain and 17 patients (34%) showed improvement in hyposmia. Overall post treatment Visual Analog Symptom (VAS) score improved in 42 patients (84%), Nasal endoscopy (Lund - Mackay scoring) improved in 43 patients (86%) and Radiological CT PNS &amp; Nose (Lund - Mackay Scoring) improved in 33 patients (66%).We found that combined therapy with oral prednisolone and fluticasone propionate nasal spray for 3 weeks is very effective in reducing the symptoms of chronic rhinosinusitis along with decrease in nasal secretions, edema and polyp size.

Fluticasone Propionate with Azelastine Versus Standalone Fluticasone Propionate as Nasal Spray in Allergic Rhinitis: A Prospective Comparative Study in a Rural Population of Northern India.

Allergic rhinitis (AR) is a symptomatic condition of the nose, caused by an IgE-mediated inflammation of the nasal membranes. Allergic rhinitis is further split into two categories, based on the duration of symptoms: intermittent (IAR) or persistent (PER) disease. Oral or topical antihistamines and topical nasal steroids are the most popular and efficient treatments for allergic rhinitis. The present prospective comparative study was done between December 2021 to November 2022, with 64 subjects of PER divided into groups A and B. Group A patients received Fluticasone propionate (50 mcg) combined with Azelastine (140 mcg) nasal spray, whereas Group B patients received standalone Fluticasone propionate (50 mcg) nasal spray. In both groups, the difference in mean TSS between the beginning and end of the 4-week study period was statistically significant (p for both < 0.05). After 4 weeks of treatment, Group A had a TSS of 2.02 ± 0.83 and Group B was at 3.80 ± 1.49; the difference between them was statistically significant (p < 0.05). According to results obtained from the current study, while both fluticasone propionate with azelastine nasal spray and standalone fluticasone propionate nasal spray are widely used for control of symptoms in PER, the former offers better results with significant reduction of symptoms when compared to the latter.

Development and Validation of Stability-Indicating Impurity Profiling Method for Azelastine Hydrochloride and Fluticasone Propionate in Nasal Spray Product Using HPLC with a UV/PDA Detector.

Azelastine HCl (AZ) and fluticasone propionate (FL) nasal spray drug product is commonly used in the treatment of allergic rhinitis worldwide. To date, the impurity profiling of this product has not been reported. The present study aimed to develop and validate a novel RP-HPLC stability-indicating analytical method for the estimation of impurities from AZ and FL nasal spray drug product. A mixture of octane sulfonic acid sodium salt and trifluroacetic acid is used as a mobile phase A. Acetonitrile is used as a mobile phase B. Good separation was achieved on Baker bond phenyl hexyl, 250 × 4.6, 5 µm column at 1 mL/min flow rate in gradient elution mode. The chromatograms were monitored at 239 nm. The LOD and LOQ were found to be 0.006 and 0.019 µg/mL for AZ and 0.010 and 0.030 µg/mL for FL, respectively. The correlation coefficient for all the known impurities and principal analytes was 0.999 from LOQ level to 150% of standard concentration. The recovery for all the known impurities was found to be between 90 and 110%. In the stress study, 15% degradation was observed in basic conditions and 8.7% in acidic conditions. No significant degradation was observed in thermal and oxidative conditions. An impurity profiling method for AZ and FL combination nasal spray product was successfully developed, validated, and demonstrated to be accurate, precise, specific, robust, and stability-indicating. The method can be routinely used for impurity testing of commercial batches in QC laboratories in the pharmaceutical industry. No impurity study has been reported for this combination product until now.

Medical treatment of otitis media with effusion using fluticasone propionate nasal spray

Objective: To determine how well fluticasone propionate aqueous nasal spray worked to reduce fluid buildup in the middle ear, a condition known as middle ear effusion. Methodology: This comparative interventional clinical study involving 70 patients with otitis media with effusion (OME) was conducted in Al-Sader Medical City in Najaf from December 2020 and January 2022. Participants had their parents' medical history and ENT exam. OME signs. These included child hearing loss and school failure. OME Otoscopy verified. Pure-tone audiometry and tympanometry followed. Group A received 100 micrograms/day (50 per nostril) fluticasone propionate aqueous nasal spray (NSS-nasal steroid spray) for 12 weeks. NS drops for B. All patients received four-week follow-up calls. Each appointment included otoscopy and audiology. Normal otoscope, type A tympanogram, and better hearing resolved OME. Results: Nasal steroids helped 40 (NSS). 35 nasal saline drop (NS) patients were 4–13 years old, averaging 8.2. After 12 weeks, group A patient who used the intranasal steroid spray exhibited a definite subjective hearing improvement, but group B patients who used nasal saline drops did not. 75% of intranasal steroid patients had type A tympanometry curves after three months (p&lt; 0.00001). Group A intra nasal steroid spray decreased PTA from 35 dB to 15 dB. Nasal saline drop patients had 25 dB PTA. Conclusion: One effective therapy for OME is the use of a steroid nasal spray. It's much safer to use now. Research on its long-term and repeated applications is necessary.

Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments of Olopatadine Hydrochloride/Mometasone Furoate Monohydrate and Azelastine Hydrochloride/Fluticasone Propionate for Allergic Rhinitis in Australia - An Observational Real-World Clinical Study.

Combination intranasal corticosteroid and antihistamine sprays are a first-line treatment option for allergic rhinitis (AR), of which Azelastine Hydrochloride and Fluticasone Propionate nasal spray (AZE/FLU; Dymista®), and Olopatadine Hydrochloride and Mometasone Furoate Monohydrate nasal spray (OLO/MOM; Ryaltris®) are currently registered in Australia. As it is not known how patients value treatment attributes of current combination nasal sprays, this observational, real-world clinical study aimed to understand patients' satisfaction with, and importance of, treatment attributes of OLO/MOM and AZE/FLU using an Anchored Best-Worst Scaling (ABWS) exercise. Four hundred and twenty-six adults in Australia with moderate to severe AR using either OLO/MOM or AZE/FLU completed an online survey incorporating an ABWS with 11 domains: 7 sensory (immediate taste of medication, aftertaste of medication, smell of medication, irritation to your nose, urge to sneeze, dripping out your nose/down your throat, dryness of your nose/throat) and 4 treatment-related (convenience, fast acting, duration of effect, and AR symptom control). The ABWS involved rescaling individual BWS scores using anchored ratings (0-10) for most and least satisfied/important domains to create a total satisfaction index (TSI) (0-100) to be compared across groups. Statistical comparisons were completed using ANOVA (TSI) and MANOVA (individual domains). Participants using OLO/MOM (M = 68.26, SE = 1.39) had significantly higher TSI than participants using AZE/FLU (M=62.78, SE = 0.70) (p < 0.001), significantly higher satisfaction on 7 of 11 domains and regarded 8 of 11 domains as significantly more important compared to participants using AZE/FLU (all p < 0.05). Preferred domains were predominantly sensory attributes. Current findings showed that participants using OLO/MOM were more satisfied with their overall treatment compared to participants using AZE/FLU, particularly with sensory attributes, thus highlighting the suitability of OLO/MOM for people with AR who value sensory attributes. Prescribers of AR treatments are encouraged to discuss treatment attributes with patients to facilitate shared decision-making.

Effects of nasal anatomical characteristics and administration parameters on delivery of locally-acting drugs with suspension nasal sprays in adults

Large intersubject variability in local drug delivery to the target regions in the nose, the region posterior to the internal nasal valve (INV), was previously demonstrated in vitro by Manniello et al. (2021), using nasal airway models from a diverse group of adults (n = 20; 21–75 years old, 50% female and 50% ≥ 50 years old) across a number of suspension nasal drug products. Upon quantification of the range of posterior deposition (PD), three nasal models representing minimum, mean, and maximum PD were previously selected by Alfaifi et al. (2022) to represent a reasonable degree of intersubject variability for nasal suspension drug products. This study investigated whether any relationship exists between the anatomical characteristics of the nasal airways and PD. Anatomical characteristics of 20 healthy adult nasal airways were measured and their relationships with previously measured in vitro PD data with fluticasone propionate (FP) and fluticasone furoate (FF) nasal spray drug products, respectively, were evaluated. The stepwise regression method was used to automatically select the potential PD predictor variables. No individual anatomical or device-related airway dimensions showed a trend or strong correlation with drug PD. A strong correlation (r2 = 0.91) was found between the PD of the FP nasal spray and a combination of main effects and two-way interactions of ten variables, including some of the dimensions of the nasal airways and administration parameters. Similarly, a correlation was found between the PD of the FF nasal spray and six parameters, although the strength of the correlation (r2 = 0.61) was less compared with the correlation for FP (r2 = 0.91). The complexity of the identified correlations supports the continued development and use of characteristic in vitro nasal geometries and accurate CFD methods to predict regional nasal spray deposition across a wide range of subjects and spray products.

Development of a Natural Preservative System in Fluticasone Propionate Nasal Spray Formulation Using Eucalyptus globulus Essential Oil

Background: Replacing all or part of synthetic preservatives with natural antimicrobials in pharmaceutical formulations can be a way to improve the safety and quality of products. Evaluating the preservative effectiveness of essential oils is valuable since most of them are generally known to be safe. Objectives: In the current research, the efficacy of Eucalyptus globulus essential oil was investigated as an antimicrobial agent individually and in combination with benzalkonium chloride in fluticasone propionate nasal spray. Methods: To determine the minimum inhibitory concentration (MIC) of E. globulus essential oil, in vitro antimicrobial activity was assayed. The stability of nasal sprays was studied in intended preservation conditions at 40°C and RH: 25 %, and also the microbial challenge test was performed according to the United States Pharmacopoeia procedure, using reference strains: Staphylococcus aureus ATCC 1112, Escherichia coli ATCC 1330, Pseudomonas aeruginosa ATCC 1074, Candida albicans ATCC 5027, and Aspergillus brasiliensis ATCC 5011. Results: The combined application of E. globulus essential oil and benzalkonium chloride at a concentration of 0.675/0.005% v/v, in nasal spray formulation could decrease the bacterial and fungal populations, in compliance with United States Pharmacopoeia criteria, with considerable preservation within 28 days of the study compared to those preserved with only benzalkonium chloride (0.02%). Conclusions: In the current research, notable antimicrobial effectiveness of the combinational preservative system was observed and followed by a decrease in the functional level of the synthetic preservative. Therefore, after further studies, a combinational preservative system can be considered as an alternative preservative for pharmaceutical formulations.

Technologies for Type 1 Diabetes and Contact Dermatitis: Therapeutic Tools and Clinical Outcomes in a Cohort of Pediatric Patients.

The increasing use of technological devices for the management of diabetes is related to the prolonged exposure of patients’ skin to chemical and mechanical agents and, consequently, to the increased risk of developing dermatological complications. Among these, contact dermatitis is the most insidious skin disorder. Despite the magnitude of the issue, no universally accepted recommendations on the management of this common complication are currently available. Our observational study aimed to describe all the solutions adopted by patients and their caregivers to treat and prevent the appearance of contact dermatitis and to describe the clinical impact of this cutaneous complication. Twenty-one pediatric patients (mean age 12.1 ± 3.7 years) with type 1 diabetes were recruited in the study. The most common treatment used to treat acute skin lesions was the application of topical corticosteroids, sometimes associated with topical antibiotics (9.5%). In order to prevent the further appearance of dermatitis, the most frequently adopted measure was the use of hydrocolloid and/or silicone-based adhesives, followed by the application of protective barrier films. One patient reported benefit from the off-label use of fluticasone propionate nasal spray. However, only 52.4% of the study participants achieved a definitive resolution of the skin issue, and 38.1% of patients were forced to discontinue insulin pump therapy and/or continuous glucose monitoring. No differences were observed in glycated hemoglobin values between the period before and after the onset of contact dermatitis. Our study confirms the severity of this dermatological complication that may hinder the spread of new technologies for the management of diabetes. Finally, our findings highlight the importance of establishing close collaboration both with pediatric allergy specialists to prescribe the most suitable treatment and with manufacturing companies to ensure that adhesives of technological devices are free of harmful well-known sensitizers.

Effect of acupuncture therapy combined with fluticasone propionate in the treatment of persistent allergic rhinitis: study protocol for a randomized controlled trial

BackgroundAllergic rhinitis (AR) is an immunoglobulin E (IgE)-mediated inflammatory response.Persistent allergic rhinitis (PAR) is a subtype of AR, but the treatment of PAR is still a problem. Acupuncture is used as an alternative therapy for AR in clinical practice. The aim of this study is to evaluate the effectiveness of acupuncture therapy combined with fluticasone propionate nasal spray in comparison to fluticasone propionate nasal spray alone in the relief of symptoms for PAR.MethodsThis study is a multicenter, single-blind, randomized controlled trial. A total of 260 eligible patients will be randomly assigned into the treatment group or the control group. The treatment group will receive the nasal fluticasone propionate combined with acupuncture, and the control group will receive fluticasone propionate nasal spray alone for 6 weeks. The primary outcome is the change in the Reflective Total Nasal Symptom Score (rTNSS) from baseline to the end of treatment, and the Total Non Nasal Symptom Score (TNNSS), reflective total ocular symptom score (rTOSS), Rhinitis Quality of Life Questionnaire (RQLQ), use of antiallergic drugs, and the Rhinitis Control Assessment Test (RCAT) are used as secondary outcomes. The participants will be followed up for another 24 weeks after treatment.DiscussionThis clinical trial will be able to provide high level evidence on the acupuncture therapy combined with fluticasone propionate nasal spray in the treatment of PAR.Trial registrationISRCTN Registry, ID: ISRCTN44040506. Registered on 22 July 2020.

Effect of Yupingfeng granule assisted fluticasone propionate nasal spray on patients with AR and its regulation on IL-5, ICAM-1 and ECP

The present investigation deals with the effect and mechanism of Yupingfeng granule assisted Fluticasone propionate nasal spray in the treatment of patients with allergic rhinitis (AR). Total of 140 patients with AR treated in Yulin Hospital of Traditional Chinese Medicine from December 2019 to July 2020 have been selected for clinical trial. The patients in traditional Chinese medicine (TCM) group were treated with Yupingfeng granule plus Fluticasone propionate nasal spray, while those in routine group are treated with Fluticasone propionate nasal spray. The remaining basic treatment in the two groups remained the same, with 60 patients in each group. Symptom, sign score, TCM syndrome score, quality of life score, interleukin-5 (IL-5), intercellular adhesion molecule-1 (ICAM-1), eosinophil cationic protein (ECP) levels in peripheral blood and clinical treatment effect have been compared between two groups before and after treatment. Before treatment, there is no significant difference in the scores of symptoms, signs and total scores between the two groups; after treatment, these were lower than those of the routine group. There is no significant difference in the scores of TCM symptoms between the two groups (P> 0.05) before treatment, while after treatment; these are lower than those of the routine group. The levels of IL-5, ICAM-1 and ECP in the peripheral blood of the patients in the two groups have been compared, and there is no significant difference between the two groups before treatment while after treatment, the levels of IL-5 and ECP in the peripheral blood of the patients in TCM group were lower than those in the routine group, and the difference had statistical significance. Yupingfeng granule assisted Fluticasone oropionate nasal spray can effectively relieve the clinical symptoms of patients with AR, improve the quality of life, regulate the levels of IL-5 and ECP in peripheral blood and improve the clinical effect.

Efficacy and safety of fluticasone propionate nasal spray in treatment ofadenoidal hypertrophic snoring in children

This study investigatedthe efficacy and safety offluticasone propionate nasal spray in treatment of adenoidal hypertrophic snoring in children.Fifty-six children with adenoidal hypertrophic snoring were enrolled. According to adenoidal-nasopharyngeal ratio (ANR) in lateral nasal X-ray examination,the children were assigned in moderategroup (23 cases) and severegroup (33 cases).The fluticasone propionate nasal spray was used for all patientsfor 4 weeks.In 56 patients, after treatment, compared with before treatment, the snoring, sleep apneaand nasal obstruction scores in moderategroupand the nasal obstruction score in severegroupwere significantly decreased,respectively (P < 0.05).The decreases of snoring, sleep apnea, mouth breathing and nasal obstruction scores after treatment in moderate group were significantly higher than those in severe group, respectively (P <0.001).After treatment, in 18 patients with ateral nasal X-ray examination,the adenoid size was obviously reduced, and the nasopharynx airway was obviously enlarged. The meanANRdropped from 0.76±0.10 to 0.72±0.09(P <0.001).Duringtreatment, only 2 of 56 patients were reported with intranasal dryness and occasional epistaxis, which were self-healed without treatment.Fluticasone propionate nasal spray is effective and safe for treatment of children’s snoring caused by adenoidal hypertrophy.

Nasal immune gene expression in response to azelastine and fluticasone propionate combination or monotherapy.

BackgroundThe combination of the antihistamine azelastine (AZE) with the corticosteroid fluticasone propionate (FP) in a single spray, has been reported to be significantly more effective at reducing allergic rhinitis (AR) symptoms than treatment with either corticosteroid or antihistamine monotherapy. However, the biological basis for enhanced symptom relief is not known. This study aimed to compare gene expression profiles (760 immune genes, performed with the NanoString nCounter) from peripheral blood and nasal brushing/lavage lysate samples in response to nasal spray treatment.MethodsModerate/severe persistent dust mite AR sufferers received either AZE (125 μg/spray) nasal spray (n = 16), FP (50 μg/spray) nasal spray (n = 14) or combination spray AZE/FP (125 μg AZE and 50 μg FP/spray) (n = 14) for 7 days, twice daily. Self‐reported symptom questionnaires were completed daily for the study duration. Gene expression analysis (760 immune genes) was performed with the NanoString nCounter on purified RNA from peripheral blood and nasal brushing/lavage lysate samples.ResultsIn nasal samples, 206 genes were significantly differentially expressed following FP treatment; 182 genes downregulated (−2.57 to −0.45 Log2 fold change [FC]), 24 genes upregulated (0.49–1.40 Log2 FC). In response to AZE/FP, only 16 genes were significantly differentially expressed; 10 genes downregulated (−1.53 to −0.58 Log2 FC), six genes upregulated (1.07–1.62 Log2 FC). Following AZE treatment only five genes were significantly differentially expressed; one gene downregulated (−1.68 Log2 FC), four genes upregulated (0.59–1.19 Log2 FC). Immune gene changes in peripheral blood samples following treatment were minimal. AR symptoms improved under all treatments, but improvements were less pronounced following AZE treatment.ConclusionAZE/FP, FP, and AZE had diverse effects on immune gene expression profiles in nasal mucosa samples. The moderate number of genes modulated by AZE/FP indicates alternative pathways in reducing AR symptoms whilst avoiding extensive local immune suppression.

Comparative nasal airflow with loratadine-pseudoephedrine and fluticasone nasal spray for allergic rhinitis

BackgroundAlthough it is known that oral antihistamine-pseudoephedrine combination tablets have a faster onset than intranasal corticosteroid sprays in the treatment of allergic rhinitis after the first dose, the magnitude of change has not been measured in a comparative manner. Furthermore, the sensation of sprayed liquid in the nose may lead patients to mistakenly believe that intranasal steroid sprays work instantly. ObjectiveTo evaluate, numerically, nasal airflow changes provided by a single dose of loratadine-pseudoephedrine tablet (LP) and fluticasone propionate nasal spray (FP) in participants experiencing allergic rhinitis symptoms, including nasal congestion. MethodsThis single-center, double-blinded, placebo-controlled, crossover study evaluated objective nasal airflow changes in patients with a documented sensitivity to ragweed pollen. Participants were randomized to receive 1 of 4 treatment sequences, and their peak nasal inspiratory flow (PNIF) was measured in a span of 4 hours after pollen exposure in an environmental exposure unit. ResultsAverage change in PNIF was 31% with LP in the course of the study, significantly greater than with placebo and FP (12% and 15%, respectively; P < .001). Nevertheless, FP did not produce a significant change compared with its placebo. At hour one post-dose, LP had a clinically significant 31% increase in PNIF, whereas FP only yielded an 8.6% increase (P < .001). Measurable nasal airflow improvements are associated with the opening of nasal passages, allowing congested patients to breathe more freely. ConclusionA single dose of LP quickly and significantly (P < .001) improved nasal airflow after ragweed pollen challenge in an environmental exposure unit. Comparatively, FP did not display this same benefit. Trial RegistrationClinicalTrials.gov Identifier: NCT03443843.

Comparative study of fluticasone propionate combined with azelastine versus fluticasone propionate alone as nasal spray in allergic rhinitis

&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Allergic rhinitis (AR) is a symptomatic disorder of the nose induced after allergen exposure due to an IgE-mediated inflammation of membranes lining the nose. Allergic rhinitis is subdivided into intermittent (IAR) or persistent (PER) disease and the severity into mild or moderate/severe. The most widely used and effective medications to treat allergic rhinitis are oral or topical antihistamines and topical nasal steroids.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This prospective case series study included 80 patients of PER divided randomly in to 2 groups of 40 each with group 1 receiving fluticasone propionate and azelastine and group 2 receiving fluticasone propionate alone. Individual symptom scores and total symptom score (TSS) were recorded before treatment and after 4 weeks of treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;&lt;strong&gt; &lt;/strong&gt;The difference in mean TSS before and after 4 weeks study period were statistically significant in both groups (p&amp;lt;0.01 in both). Group 1 had TSS of 1.525±1.06 and group 2 had TSS of 3.275±1.75 after 4 weeks of treatment and the difference between them was statistically significant (p&amp;lt;0.01).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;In allergic rhinitis, both fluticasone propionate + azelastine nasal spray and fluticasone propionate nasal spray are effective in relieving symptoms. But, fluticasone propionate and azelastine has significant reduction of symptoms when compared with fluticasone propionate alone.&lt;/p&gt;

A MASS COMPATIBLE UPLC METHOD FOR THE QUANTIFICATION OF IMPURITIES IN FLUTICASONE PROPIONATE NASAL SPRAY

Objective: The objectives of the present study were to develop and validate a mass compatible ultra-performance liquid chromatography (UPLC) method to quantify the impurities in fluticasone nasal spray, and to establish a suitable container-closure system for the formulation.&#x0D; Methods: A gradient method was optimized with a flow rate of 0.5 ml/min, detector wavelength-240 nm, run time-25 min and 0.1% Trifluoroacetic acid (TFA) in water as solvent A and Methanol as solvent B.&#x0D; Results: The developed method was linear over the range of 0.07-1.10 µg/ml for impurity-I, 0.16-2.47 µg/ml for impurity-II, 0.67-10.0 µg/ml for impurity-III, and 1.29-19.3 µg/ml for impurity-IV. The limit of quantification (LOQ) and limit of detection (LOD) were established as 0.07 and 0.02 µg/ml, 0.14 and 0.05 µg/ml, 0.59 and 0.19 µg/ml, 1.06 and 0.35 µg/ml for impurities I-IV respectively. The percent relative standard deviation (%RSD) of the replicate analysis for impurities I-IV, was within the acceptance criteria (0.4, 0.2, 0.3, and 0.1% respectively) that proved the precision of the method. The accuracy of the method was studied from 50%-150% of test concentration and the results ranged from 100.3% to 109.4%. The container-closure compatibility study revealed that the solution stored in the glass container system did not generate any additional peaks in the chromatogram.&#x0D; Conclusion: Hence, the developed method can be employed by quality testing laboratories to quantify impurities in fluticasone propionate nasal spray. The study also suggests that glass containers could serve as a compatible system for the storage of fluticasone propionate nasal solution.

A comparative study to assess the efficacy of fluticasone and mometasone in allergic rhinitis

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; Allergic rhinitis is the most prevalent of allergic diseases in the world. Pharmacotherapy remains the mainstay of treatment.  Nasal corticosteroids being the most applicable drugs for its treatment. The objective of this study was to compare the efficacy of fluticasone propionate (FP) and mometasone furoate (MF) nasal sprays in the treatment of allergic rhinitis based on total nasal symptom score (TNSS) questionnaire.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; A prospective, randomized, open-label, parallel-group, comparative study was conducted among 80 allergic rhinitis patients fulfilling the inclusion and exclusion criteria. They were randomly assigned to two groups: FP and MF groups. FP group received 200 µg dose of FP nasal spray (1 spray/nostril) daily and the MF group received 100 µg dose of MF nasal spray (1 spray/nostril) daily for 8 weeks. The effects of the two agents were compared based on TNSS questionnaire in 0, 4 and 8 weeks after the beginning of the treatment.  &lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; At the end of eight weeks of treatment, both groups showed statistically significant (p&amp;lt;0.005) improvements from their baseline TNSS. Mean TNSS was reduced from to 9.46 to 2.716 in FP group and from 10.18 to 2.504 in MF group.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Both the groups showed a significant therapeutic benefit in patients with allergic rhinitis. Even though, the difference between the two is not significant for 8 weeks therapy.   &lt;/p&gt;