Fluticasone propionate 50micrograms/dose / Azelastine 137micrograms/dose nasal spray

Background/Objectives: Paediatric Obstructive Sleep Apnoea (OSA) is characterised by recurrent episodes of upper airway obstruction during sleep, manifesting as snoring, intermittent oxygen desaturation, and frequent nocturnal awakenings. Standard treatments include surgical interventions, pharmacological therapies, intranasal corticosteroids, and oral montelukast. However, significant variability exists across studies regarding dosage and outcome assessment. This literature review systematically evaluated clinical evidence regarding the efficacy and safety of intranasal corticosteroids and oral montelukast for treating sleep-disordered breathing and its primary underlying condition, adenoid hypertrophy, in otherwise healthy children. Methods: The MEDLINE (PubMed), Scopus, and Web of Science databases were systematically searched up to 13 February 2025, using tailored search terms combining keywords and synonyms related to paediatric OSA, adenoidal hypertrophy, corticosteroids, montelukast, and randomised controlled trials. Owing to variability in outcome measures, Fisher's method for p-value combination was employed to enable a comprehensive comparison of drug effects. Results: Available evidence shows that intranasal corticosteroids (mometasone, beclometasone, budesonide, fluticasone, and flunisolide), either as monotherapy or in combination with other agents, consistently lead to clinical and instrumental improvements in adenoid hypertrophy and related respiratory symptoms, with a generally favourable safety profile. Combining montelukast with intranasal corticosteroids appears to offer superior benefits compared with monotherapy. Nevertheless, the reviewed studies varied widely in dosage, treatment duration, design, and sample size. The reported side effects are mostly mild; however, long-term studies are lacking to establish the complete safety of these treatments in children. Conclusions: Intranasal corticosteroids and oral montelukast effectively and safely manage adenoid hypertrophy and mild-to-moderate OSA symptoms in children. Nonetheless, the heterogeneity of study designs necessitates larger prospective trials with standardised protocols and more extended follow-up periods to draw more robust conclusions. Future studies should aim to stratify treatment outcomes based on OSA severity and duration to tailor therapeutic approaches better.

Abstract licence: CC BY

BackgroundProphylactic treatment for pollinosis is advantageous for managing nasal symptoms in patients with seasonal allergic rhinitis. Inadequate control of rhinitis symptoms increases the risk of acute asthma attacks. Nevertheless, there is limited research on the use of nasal glucocorticoids and antihistamines for the preventive treatment of pollinosis.ObjectiveThis study aimed to assess the efficacy of prophylactic treatment for nasal symptoms and acute asthma attacks by enrolling patients with Artemisia pollinosis to use a combined device of azelastine hydrochloride and fluticasone nasal spray prior to the pollen season.MethodsThe study was registered at Chictr.org.cn (ChiCTR2300073758). A total of 120 patients with Artemisia pollinosis were randomly assigned to either a prophylactic treatment group or a control group at a 1:1 ratio. In the prophylactic treatment group, the nasal spray was initiated approximately two weeks before the onset of the pollen season.ResultsDuring both the pollen season and the concurrent medication period, the prophylactic treatment group presented significantly lower total nasal symptom scores (TNSS) (means of 5.97 and 5.94) than the control group (means of 7.86 and 7.80) (P = 0.015 and 0.016). Although the prophylactic treatment group had a lower asthma attack rate than the control group, the difference was not statistically significant (P = 0.284).ConclusionsProphylactic treatment with azelastine hydrochloride and fluticasone propionate nasal sprays can alleviate nasal symptoms and may reduce acute asthma attacks during the pollen season. Clinical Trial Registration[Chictr.org.cn], identifier (ChiCTR2300073758).

Abstract licence: CC BY 4.0

Allergic rhinitis (AR) is a common chronic respiratory disease that significantly impairs the life of children. While a combination intranasal spray of azelastine hydrochloride and fluticasone propionate (Aze-Flu) is an established effective treatment for adults with moderate-to-severe AR, the clinical evidence available in the pediatric population is limited. This review summarizes the current evidence on the efficacy, safety, and impact on Quality of Life (QoL) of Aze-Flu in children. Clinical trials have demonstrated that Aze-Flu provides faster and greater symptom relief in children with AR compared to fluticasone propionate (FP) monotherapy. One randomized controlled trial demonstrated that, although the overall change in the reflective Total Nasal Symptom Score (rTNSS) was not statistically different from the placebo, this was possibly due to rater assessment bias. Children’s symptoms self-assessment showed considerable ameliorations in both nasal and ocular scores. Furthermore, treatment with Aze-Flu has been shown to produce clinically relevant and statistically significant improvements in QoL compared to placebo in children with moderate-to-severe seasonal AR. The safety profile is favorable; a 3-month study confirmed that Aze-Flu is well-tolerated, with an incidence of treatment-related adverse events comparable to that of FP monotherapy. Beyond AR, emerging evidence suggests potential benefits of Aze-Flu in children with adenoid hypertrophy. The available evidence supports Aze-Flu as an effective and well-tolerated therapeutic option for children with moderate-to-severe AR, offering superior and faster symptom control than monotherapy and leading to meaningful improvements in quality of life. Future pediatric trials should incorporate validated, child-specific assessment tools to better capture treatment efficacy.

Abstract licence: CC BY 4.0

Patients with obstructive sleep apnea (OSA) often struggle with CPAP therapy adherence. The intranasal corticosteroids (INS) alone have not significantly improved CPAP adherence but the combination drugs that faster relieved symptoms were not well studied. This study aimed to assess the combined effectiveness of INS (fluticasone propionate) and intranasal antihistamines (azelastine hydrochloride) in enhancing CPAP adherence and mitigating CPAP-induced rhinitis symptoms in OSA patients. A double-blind, randomized controlled trial with stratified random sampling was conducted at Thammasat University Hospital from March 2022 to March 2023. Participants included OSA patients undergoing CPAP treatment. The patients completed questionnaires and interviews at the baseline, the second week, and one month after starting CPAP therapy, with CPAP usage electronic data collected. Among 116 enrolled patients, most had severe OSA (78.9%), with a majority being male (56.9%). The intervention group did not significantly differ from the placebo group in terms of CPAP usage, nasal symptoms, quality of life, or side effects. Subgroup analysis showed improved CPAP adherence in the treatment group when using pressure below 15 cm H 2 O (7.8% increase in CPAP usage days, P = 0.04). This study marks the first evaluation of combination drugs for enhancing CPAP therapy adherence in OSA patients. Although these drugs did not significantly enhance overall CPAP adherence, there was a trend toward increasing CPAP adherence in patients using lower pressure levels. Thus, combining fluticasone and azelastine may benefit certain OSA patients. Further research is essential to comprehend and validate these benefits fully. Clinicaltrials.in.th number TCTR20220308003 (08/03/2022).

Abstract licence: CC BY-NC-ND 4.0

BackgroundSymptom control in patients with moderate-to-severe persistent allergic rhinitis (PAR) who remain inadequately controlled on intranasal corticosteroid monotherapy remains challenging, highlighting the urgent need for more effective treatments. This study aimed to determine whether the addition of nasal saline irrigation to a regimen of intranasal corticosteroids and antihistamines can further improve symptoms in patients with moderate-to-severe PAR.MethodsA multicenter, randomized, open-label, controlled trial was conducted, enrolling 248 eligible patients aged 12 years and above from six clinical centers. They were randomized 1:1 into two groups. The experimental group received nasal saline irrigation combined with azelastine-fluticasone (Aze-Flu) nasal spray, and the control group was treated with azelastine nasal spray and fluticasone nasal spray. The primary outcome was the least-squares-mean (LSmean) change in total nasal symptom score (TNSS) from baseline to four weeks, with secondary outcomes including LSmean change in TNSS from baseline to two weeks, subscores, rhinoscopic scores, visual analogue scale (VAS), and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores.ResultsBoth groups exhibited significant reductions in TNSSs from baseline (p < 0.001). In comparison to the control group, the experimental group exhibited greater LSmean changes in TNSS scores following either two or four weeks of treatment (p < 0.001 at both time points). The experimental group presented more favorable changes in rhinoscopy scores, VAS scores, and RQLQ scores. Both groups showed no substantial differences in adverse events, indicating a comparable safety profile.ConclusionNasal saline irrigation combined with Aze-Flu nasal spray provides additional benefits in managing moderate-to-severe PAR, with good safety and tolerability. This combination therapy could be a valuable option in primary care settings.Clinical Trial Registrationhttp://www.medicalresearch.org.cn, identifier (MR-32-23-044661).

Abstract licence: CC BY 4.0

BackgroundMP-AzeFlu (Dymista; Meda Pharma GmbH & Co., KG), a formulation combining azelastine hydrochloride and fluticasone propionate in a single spray, is superior to fluticasone propionate alone in relieving symptoms and improving the quality of life of patients with allergic rhinitis.ObjectivesIn this study, we evaluated whether the effect of AzeFlu, a generic drug manufactured from China, is equivalent to that of MP-AzeFlu.MethodsIn total, 679 patients were recruited for a multicentre, randomized, double-blind, original drug-controlled, and parallel-group clinical trial. Overall, 339 and 340 patients were administered with AzeFlu and MP-AzeFlu, respectively. Efficacy was assessed by changes in the reflective total nasal symptom score, the area under the curve of reflective total nasal symptom score changes over time, changes from baseline in individual nasal symptom scores, and the Rhinoconjunctivitis Quality of Life Questionnaire. In addition, a safety evaluation was simultaneously performed.ResultsAzeFlu and MP-AzeFlu reduced the reflective total nasal symptom score from baseline (AzeFlu -6.7 [standard deviation, 2.59]; MP-AzeFlu -6.7 [standard deviation, 2.76]; P = 0.905) and improved nasal symptoms and quality of life (AzeFlu -62.3 [standard deviation, 33.59]; MP-AzeFlu -64.7 [standard deviation, 33.73]; P = 0.394) in patients with allergic rhinitis. Significant differences were not observed between groups.ConclusionAzeFlu showed effects equivalent to those of MP-AzeFlu in this clinical trial and may benefit Chinese patients with allergic rhinitis.Registration number: CTR20190189 (chinadrugtrials.org.cn/index.html).

Abstract licence: CC BY-NC-ND