Fluticasone Propionate Aqueous Nasal Spray Research Articles

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< 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.

Comparison of C-reactive protein and Vitamin D3 level among Patients of Allergic Rhinitis while on treatment with either Nasal Fluticasone or Combination Therapy of Montelukast and Levocetirizine: A Randomized Control Study

We conducted the present study to compare the vitamin D3 status and C-reactive protein (CRP) among allergic rhinitis patients who were on treatment with either intranasal Fluticasone or oral Levocetrizine and Montelukast therapy. Material and Methods: The study was a prospective randomized, single blinded, comparative, parallel group study, with two intervention groups conducted at Civil Hospital Jogindernagar of Himachal Pradesh, India. A total of Fifty patients diagnosed with allergic rhinitis was randomly allocated to either Group A receiving oral Montelukast and Levocetrizine or Group B receiving Fluticasone propionate aqueous nasal spray and followed up for 6 weeks. Vitamin D status and C-reactive protein (CRP) after 6 weeks was taken as primary outcome variables. Results: Among Group A , Recovery at 6 weeks was occurred in 9 (36%) patients while in Group B Recovery at 6 weeks was occurred in 17(68 %) patients.(p value 0.046). There was statistically significant lower mean CRP level was found in group B as compared to Group A (p value 0.003). Although, lower mean Vit D3 level was found in group B as compared to Group A but this difference was not found to be statistically significant. (p value 0.218). Although, lower mean CRP and higher mean Vit D3 level was found in recovered patients in group A as compared to who were not recovered but this difference was not found to be statistically significant(p value 0.198 and 0.324 respectively). Similarly,higher mean CRP and Vit D3 level was found in recovered patients in group B as compared to who were not recovered but this difference was not found to be statistically significant.( p value 0.804 andp value 0.418). Similarly ,in recovered patients there was no statistical significant difference in mean CRP and Vit D3 level(P value 0.9536 and 0.2486 respectively) in both groups, although the mean CRP and Vit D3 level were higher in Group A as compared to group B. But in non recovered patients, the mean CRP level was statistically higher in Group A as compared to group B(P value0.0029) while there was no statistical significant difference in Vit D3 level in both groups.(p value-0.8919). Conclusion: Study concluded that there was no statistical significant difference in mean Vitamin D3 and CRP levels in both groups as well as there was no significant association between Vitamin D3 and CRP levels and recovery status of patients in both groups.

Effect of intranasal steroids on rhinosinusitis after radiotherapy for nasopharyngeal carcinoma: clinical study

Post-irradiation rhinosinusitis is one of the most common untoward side effects in patients with nasopharyngeal carcinoma. This study aimed to evaluate the effect of fluticasone propionate aqueous nasal spray on post-irradiation rhinosinusitis. Nasopharyngeal carcinoma patients who had undergone radiotherapy and subsequently developed chronic rhinosinusitis were randomised to receive either fluticasone propionate aqueous nasal spray 200 µg plus nasal irrigation or a single nasal irrigation, for six months. A questionnaire, nasal endoscopy and computed tomography were used to evaluate rhinosinusitis severity, at the beginning of treatment, and at three and six months after treatment. The group who received fluticasone propionate aqueous nasal spray combined with irrigation had fewer nasal complaints (overall symptoms, blocked nose and headache were reduced), a better quality of life and less severe endoscopic findings than those who only received nasal irrigation at three and six months after treatment. Nasal steroids are a safe and effective therapy for patients with post-irradiation rhinosinusitis.

Comparison of Oral Montelukast and Intranasal Fluticasone in Patients with Asthma and Allergic Rhinitis.

Even though the links between upper and lower airway had been of interest to clinicians since long back, it has not attracted the attention of the researchers till recent past. But the evidence is still far from conclusive, due to limited number of randomized controlled trials available on subjects with concomitant allergic rhinitis and asthma. This gap in the knowledge is even more conspicuous in Indian population. The current study is conducted with an objective of comparing the efficacy and tolerability of intranasal Fluticasone and oral Montelukast in treatment of allergic rhinitis and bronchial asthma. The study was a prospective randomized, single blinded, comparative, parallel group study, with two intervention groups conducted in a tertiary teaching hospital in Chennai, Southern India. One hundred and twenty patients diagnosed with concomitant diagnosis of allergic rhinitis and bronchial asthma was randomly allocated to either Fluticasone propionate aqueous nasal spray or oral Montelukast group. Out of total 120 subjects recruited, 108 subjects were included in the final analysis. The mean reduction in asthma and rhinitis symptom scores and improvement in PEFR was higher for Group A, compared to Group B during all the follow-up periods. No statistically significant difference was observed in proportion of subjects reporting exacerbations in the current study. Both the treatments were well tolerated. Addition of intranasal Fluticasone propionate to Salmeterol plus Fluticasone is beneficial in improving asthma control, allergic rhinitis control and lung functions as compared to oral Montelukast. Thereby the use of intranasal Fluticasone Propionate in comparison to oral Montelukast in control of Allergic Rhinitis is justified as per the significant improvement in outcome measures.

Fluticasone propionate点鼻液の臨床的検討 (第5報)

Fluticasone propionate点鼻液の臨床的検討 (第5報)

Fluticasone propionate点鼻液の臨床的検討 (第3報)

Fluticasone propionate点鼻液の臨床的検討 (第3報)

Fluticasone propionate点鼻液の臨床的検討 (第6報)

Fluticasone propionate点鼻液の臨床的検討 (第6報)

Fluticasone propionate点鼻液の臨床的検討 (第4報)

Fluticasone propionate点鼻液の臨床的検討 (第4報)

Nasal steroids improve regulation of nasal patency in asthma and mild rhinitis: a randomised, cross-over trial

An important function of the healthy nose is the ability to adjust nasal patency in response to stimuli such as a change in posture between sitting and supine. We hypothesised that the regulation of nasal patency would be impaired in patients with asthma and mild rhinitis and that it could be improved by reducing nasal inflammation with a topical nasal steroid. This is a randomised, placebo-controlled, double-blind, cross-over study comprising 19 subjects with well-controlled asthma and a history of rhinitis without current treatment. The subjects were randomised to fluticasone propionate aqueous nasal spray (Beconase(®)), 200 μg daily, or placebo (FESS(®) saline nasal spray), for 6 weeks in a cross-over design with a 4-week wash-out between treatments. Nasal patency was measured with acoustic rhinometry, while sitting and supine and with peak nasal inspiratory flow (PNIF). Treatment response was also monitored with spirometry, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Short Form-36 (SF-36), and The Pittsburgh Sleep Quality Index. The minimal cross-sectional area remained unchanged between sitting and supine at baseline and after placebo but after fluticasone propionate there was a significant decrease. PNIF, RQLQ and SF-36 improved after fluticasone propionate, whereas sleep quality did not change. In well-controlled asthma and mild rhinitis, nasal steroid treatment normalised the neurovascular response to posture in the nasal mucosa and improved health-related quality of life. An impaired ability to regulate nasal patency could be a marker of upper airway inflammation in patients with asthma that can be measured non-invasively.

Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis

Limited information exists comparing fluticasone propionate/salmeterol combination (FSC) versus montelukast (MON) in patients with coexistent asthma and allergic rhinitis. The purpose of this study was to compare the addition of MON to patients receiving FSC on asthma control while experiencing asthma and allergy symptoms. Additionally, the effect of fluticasone propionate aqueous nasal spray (FPANS) and MON were assessed in allergic rhinitis control. Symptomatic patients (n = 1385) with asthma and seasonal allergic rhinitis were randomized to receive FSC, 100/50 micrograms twice daily; FSC twice daily + FPANS, 200 micrograms once daily; FSC twice daily + MON, 10 mg once daily; or MON once daily for 4 weeks during the allergy pollen season. Patients recorded peak expiratory flow, rescue albuterol use, and asthma and rhinitis symptoms. No additional improvements in overall asthma control were seen when MON was added to FSC. Treatment with FSC produced significant (p < 0.001) improvements in all clinical and patient-reported measures versus MON. FSC + FPANS was superior to FSC + MON (p < or = 0.001) in improving daytime and nighttime total nasal symptom scores. Adverse events were similar. In patients with asthma and allergic rhinitis, adding MON to FSC provided no additional benefit in asthma control. FSC resulted in superior improvement in asthma control compared with MON. FPANS also provided superior nasal symptom control versus MON in allergic patients treated with FSC for asthma. Optimal disease control in patients with asthma and allergic rhinitis should be achieved by the most effective therapy directed toward each disease component.

EQUIVALENCIA CLÍNICA ENTRE EL ROCIADOR NASAL DE PROPIONATO DE FLUTICASONA GENÉRICO Y COMERCIAL EN PACIENTES CON RINITIS ALÉRGICA

Objective. The primary objective of this study was to establish the clinic equivalence of a new Fluticasone Propionate Aqueous Nasal Spray (FANS) compared to two commercially available active treatments of fluticasone propionate nasal spray (Flonase and Flixonase ) during the mountain cedar ( Juniperus ashei ) pollen season in Texas. Material and methods. This was a multicenter, randomized, double-blind, double-dummy, active-controlled and placebo-controlled, parallel group study designed to investigate the safety and efficacy of FANS (200 mcg QD), Flonase and Flixonase (200 mcg QD) compared to placebo administered for 13 to 15 days. Patients recorded the total nasal symptoms dcores (TNSS) in a diary in the morning and evening every day. The primary endpoint was the patient-rated am and pm TNSS +1. Other key efficacy endpoints were patient-rated AM TNSS+1, patient-rated PM TNSS+1, and safety. Results. Mean TNSS values for Flonase and Flixonase were not statistically significantly different from FANS during any study day, over the entire treatment period, or at endpoint. Bioequivalence between FANS and Flonase (ratio= 0.98, 90% CI 0.91 to 1.06) as well as FANS and Flixonase (ratio=1.02, 90% CI 0.94 to 1.10) was demonstrated for the primary endpoint [Patient-Rated am and pm TNSS +1] as well as for the other key efficacy endpoints. Conclusions. The findings from this study support that FANS 200 mcg QD is therapeutically bioequivalent to both Flonase and Flixonase in the control of the symptoms of seasonal allergic rhinitis.

Long‐term study of fluticasone propionate aqueous nasal spray in acute and maintenance therapy of nasal polyposis

Topical steroids are first-line medication to control nasal polyposis (NP), a disease with long-term clinical course. The aim of this study was to evaluate the efficacy and safety of fluticasone propionate aqueous nasal spray (FPANS) 200 microg twice a day (bd) after 1 month of treatment, and to compare FPANS 200 microg bd and FPANS 200 microg once a day (od) in maintenance and long-term treatment. Double-blind, placebo-controlled, 8-month study with three treatment periods (1-month acute period followed with 1-month maintenance period and 6-month follow-up period) was carried out. Group 1 received FPANS 200 microg bd, during acute, maintenance and follow-up periods, Group 2 received FPANS 200 microg bd during acute period and FPANS 200 microg od during maintenance and follow-up periods, and Group 3 received placebo during acute and maintenance periods and FPANS 200 microg bd during follow-up period. Endpoints were change from baseline in clinic peak nasal inspiratory flow (PNIF), domiciliary evening PNIF, intensity of symptoms and polyposis grade. After acute period and maintenance periods, FPANS 200 microg bd was significantly more effective than placebo on all endpoints and more effective than FPANS 200 microg od after 1-month maintenance period on clinic PNIF, evening PNIF, obstruction, percentage of days with no sense of smell and percentage of nights with no disturbances. The two doses were similar on other endpoints. After the 6-month follow-up period, there was no difference between the two doses of FPANS at all efficacy endpoints. The safety profile of FPANS did not highlight any new or unanticipated adverse events. The study demonstrated the efficacy of FPANS 200 microg bd in acute treatment and FPANS 200 microg od as a sufficient dose to maintain a long-term efficacy in the treatment for NP.

FLUTICASONE PROPIONATE/SALMETEROL VIA DISKUS IS SUPERIOR TO MONTELUKAST IN OVERALL ASTHMA CONTROL IN SUBJECTS WITH BOTH ASTHMA AND ALLERGIC RHINITIS

PURPOSE: Asthma and seasonal allergic rhinitis often coexist and symptoms manifest concurrently. However, limited data is available regarding the role of fluticasone propionate/salmeterol (FSC) in this population. This study compared the effect of FSC vs montelukast (MON) on asthma control in subjects with active asthma and allergic rhinitis symptoms. In addition, this study was designed to evaluate whether fluticasone propionate aqueous nasal spray (FPANS) was superior to MON for control of allergic rhinitis in the presence of FSC.

Comparison of fluticasone propionate aqueous nasal spray and oral montelukast for the treatment of seasonal allergic rhinitis symptoms

Few studies have directly compared the efficacy of intranasal corticosteroids with that of leukotriene receptor antagonists for the treatment of daytime and nighttime symptoms of seasonal allergic rhinitis (SAR). To compare fluticasone propionate aqueous nasal spray, 200 microg daily, with oral montelukast, 10 mg daily, for the relief of SAR symptoms. Patients with SAR 15 years or older were randomized to receive either fluticasone propionate (n = 367) or montelukast (n = 369) in this double-blind, double-dummy, parallel-group study. The primary efficacy measure was the mean change from baseline in daytime total nasal symptom scores (TNSSs) (the sum of 4 daytime individual nasal symptom scores [INSSs] assessing nasal congestion, itching, rhinorrhea, and sneezing), averaged across weeks 1 and 2. Secondary efficacy measures included the 4 daytime INSSs, nighttime TNSSs (the sum of 3 nighttime INSSs assessing congestion on awakening, difficulty going to sleep, and nighttime awakenings), and the 3 nighttime INSSs averaged across weeks 1 and 2. Mean changes from baseline in daytime TNSSs (P < .001), all daytime INSSs (P < .001), nighttime TNSSs (P < .001), and all nighttime INSSs (P < or = .02) showed significant differences favoring fluticasone propionate over montelukast across 2 weeks of treatment. Compared with montelukast, fluticasone propionate provided significantly greater improvement in daytime and nighttime SAR symptoms.

CT assessment of the effect of fluticasone propionate aqueous nasal spray treatment on lower turbinate hypertrophy due to vasomotor rhinitis

Conclusion. Fluticasone propionate (FP) aqueous nasal spray was objectively found to be effective and safe for the treatment of lower turbinate enlargement in patients with vasomotor rhinitis. Objective. To assess the efficacy of FP aqueous nasal spray treatment in lower turbinate hypertrophy due to vasomotor rhinitis using CT. Material and methods. Of 35 patients with hypertrophic lower turbinates due to vasomotor rhinitis, 20 were treated twice daily with FP aqueous nasal spray (200 µg/day) for 3 months continuously and 15 were treated with placebo vehicle as a control group. The local effect of the nasal spray was studied using CT and visual analog scales. Results. Treatment with FP provided significantly greater relief from the symptom of nasal obstruction compared with placebo over the entire 3-month treatment period (p < 0.001). When the change from baseline was compared between the two groups, FP produced statistically significant reductions in the mucosal area of the lower turbinates and in the thickness of the nasal mucosa after 3 months (p < 0.05).

好酸球性副鼻腔炎に対するフルチカゾン噴霧療法（倍量投与）の試み

Chronic sinusitis with eosinophils easily recurs after endoscopic sinus surgery. The condition is usually complicated by asthma, and many eosinophils are present in the sinus mucosa. One conservative treatment method is the administration of glucocorticoids locally or systematically. To evaluate the efficacy and tolerability of intranasal fluticasone propionate for the treatment of chronic sinusitis with eosinophils, seven patients with chronic sinusitis with eosinophils were treated over a 12-week period using a fluticasone propionate aqueous nasal spray (800 microg per day in each nostrilz). The Symptons of 7 patients, especially nasal discharge and nasal obstructions, improved and an expanded air space was observed on paranasal CT images. The percent of drug systemically available after intranasal administration varied by less than 1% for intranasal fluticasone propionate. Therefore, even if intranasal fluticasone propionate is administerved at double the usual dose, it is unlikely to cause systemic side effects. Fluticasone propionate aqueous nasal spray at double the usual dose is effective for the treatment of chronic sinusitis with eosinophils.

Evaluation of an intranasal house dust mite provocation model as a tool in clinical research

As a result of the all-year-round exposure to house dust mite (HDM), perennial rhinitis patients never have a clear symptom-free period. In this study, we investigated whether, despite these symptoms, we can still use nasal HDM provocations to study perennial allergic rhinitis and the effects of treatment. In a parallel-group study, after 1 week treatment with either fluticasone propionate aqueous nasal spray (FPANS) or placebo, 20 patients, allergic to HDM, registered symptoms (nasal obstruction, rhinorrhoea, sneezing, pruritus and eye symptoms) using three different scoring methods [Lebel, categorical and visual analogue scale (VAS)] and peak nasal inspiratory flow (PNIF) after HDM provocations. Provocations were performed with 1000 biological units/ml and 24 h later with 10,000 biological units/ml of HDM. Before and after the provocations, nasal mucosa biopsies were taken for immunohistochemical staining to determine the number of eosinophils. House dust mite provocations resulted in an increase in symptoms and a decrease in PNIF. Even at high-dose provocation, the FPANS group registered significantly lower symptoms than the placebo group for nasal blockage, sneezing, eye symptoms, and PNIF in both early and late phases. FPANS also suppressed rhinorrhoea during the late phase and the influx of eosinophils in the lamina propria. Despite the high background of symptoms, allergic responses can be induced in this perennial rhinitis model. The VAS score seems most suited to detect these changes and the suppression of symptoms by 7 days of FPANS treatment. Epithelial eosinophilia at baseline was correlated positively with the severity of the reaction after the first provocation.

Comparison of the effects of fluticasone propionate aqueous nasal spray and loratadine on daytime alertness and performance in children with seasonal allergic rhinitis

Concern has been directed at the relative sedating properties of lipophilic and lipophobic antihistamines, but few studies have sought to determine the comparative benefit of seasonal allergic rhinitis (SAR) treatments in controlling symptoms and consequently improving alertness. To compare the relative contributions of fluticasone propionate aqueous nasal spray and loratadine in enhancing daytime performance in 8- to 17-year-old children. All participants had a documented history of SAR, positive response to a skin prick (wheal 3-mm greater than negative control or equal to the positive control) for seasonal aeroallergens, and clinically identifiable symptoms at the time of randomization. Following confirmation during baseline of current SAR symptoms, participants were randomized to 1 of the 2 treatments and returned 2 weeks later for evaluation of symptom control, quality of life, attention, reaction time, and memory. Children in the fluticasone propionate aqueous nasal spray group but not the loratadine group demonstrated improvement in nasal symptoms, nasal quality of life score, and composite verbal memory. No differences were identified on any scores from the Conners Continuous Performance Test. Treatments that most effectively control SAR symptoms are also likely to provide the greatest benefit to children whose daytime functioning, including their capacity to learn at school, is compromised by their illness.

A subgroup analysis in hispanic patients with allergic rhinitis of fluticasone propionate aqueous nasal spray for sinus pain and pressure caused by nasal congestion

Rationale Sinus pain and pressure (SP+P) is a common symptom of allergic rhinitis. Fluticasone propionate aqueous nasal spray (FP) has been shown to reduce SP+P associated with allergies. Most research studies report findings for Caucasian and African American subgroups. Few research studies report findings for Hispanic patients, a growing population in the United States. Methods Two multi-center, double-blind, placebo-controlled, parallel-group studies compared daily dosing of FP 200μg (FP200QD) or placebo in 401 patients (age 12-74) with moderate-to-severe SP+P and nasal congestion. Of these, 115 Hispanic patients received either FP200QD (n=53) or placebo (n=62). Patients used a 100mm visual analog scale each evening to assess the severity of SP+P experienced over the day. Mean change from baseline for SP+P was determined over the 14-day treatment period. Descriptive statistics were displayed for the Hispanic subgroup and the magnitude of improvement was compared to the total population. Results Mean (SE) SP+P scores at baseline were similar for the total populations and Hispanic subgroups ranging from 71.0 (1.98) to 80.3 (2.10). Over the 14-day treatment period, mean changes (SE) from baseline in Study FNM40184 and FNM40185, respectively, were -19.6 (2.41) and -17.8 (2.10) for placebo compared with -26.4 (2.20) and -27.8 (2.41) for FP200QD in the total population (p<0.05 for each study). In the Hispanic subgroups, mean changes (SE) from baseline were -17.2 (4.15) and -21.8 (3.70) for placebo compared with -23.8 (4.44) and -27.0 (5.13) for FP200QD. Conclusions These studies suggest that FP200QD improves sinus pain and pressure in Hispanic patients with allergic rhinitis.

Fluticasone propionate aqueous nasal spray improves nasal symptoms of seasonal allergic rhinitis when used as needed (prn)

Few published clinical trials document the efficacy of intranasal corticosteroids used as needed for treatment of seasonal allergic rhinitis. To evaluate the efficacy and safety of 4 weeks' treatment with fluticasone propionate aqueous nasal spray 200 microg used as needed (FP200PRN) in patients with seasonal allergic rhinitis. A randomized, double-blind, placebo-controlled study in 241 patients (> or = 12 years of age) with a positive skin test result to a relevant fall allergen and who were symptomatic at randomization. The primary endpoint was the mean change from baseline in total nasal symptom score (TNSS; the sum of nasal congestion, rhinorrhea, sneezing, and nasal itching, each rated on a 4-point scale from 0 = none to 3 = severe). The mean percentage of days that patients used the study medications in the FP200PRN and placebo groups was 61.8% (SD = 30.4%) and 70.1% (SD = 28.3%), respectively. Patients treated with FP200PRN had a significantly greater reduction from baseline in TNSS compared with those treated with vehicle placebo (mean +/- SE = -2.02 +/- 0.18 vs -1.06 +/- 0.22, P < 0.001), representing a 91% greater improvement with FP200PRN than vehicle placebo. The FP200PRN group also had a significantly greater (P < 0.001) mean reduction in individual nasal symptoms of rhinorrhea, sneezing, nasal itching, and nasal congestion compared with placebo. FP200PRN was well tolerated, with an incidence of adverse events comparable to vehicle placebo. FP200PRN in patients 12 years and older is effective for treatment of nasal symptoms associated with seasonal allergic rhinitis. It has a lower incidence of adverse events than typically associated with regular once-daily use.