The efficacy of oral montelukast versus intranasal fluticasone furoate in reducing the severity of pediatric sleep-disordered breathing: A randomized clinical trial.
Aug 2026· International Journal of Pediatric Otorhinolaryngology· Vol 209, pp.
112971
· 0 citations· 27 references
Medicine
TL;DR
Fluticasone furoate may be appropriate for adenoid hypertrophy, while montelukast is favored for concurrent tonsillar hypertrophy, and these treatments may serve as alternatives to surgery in selected cases.
Abstract
Objectives
To compare the clinical efficacy of oral montelukast versus intranasal fluticasone furoate in reducing the severity of sleep-disordered breathing (SDB) among children with adenotonsillar hypertrophy.
Methods
A prospective randomized clinical trial was conducted between 9/2022 and 4/2023, including children aged 2-15 years with SDB and adenotonsillar hypertrophy. At baseline, all participants underwent symptom assessment using the Pediatric Sleep Questionnaire (PSQ), followed by physical examination. Subjects were randomized to receive either oral montelukast or intranasal fluticasone furoate for two months. Following treatment, the children were re-evaluated, and if no clinical improvement was observed, surgery was scheduled.
Results
Sixty-seven children with a mean age of 5.25 years (45, 67% males) were included. The median PSQ score improved in the montelukast group from 0.45 to 0.28 (p = 0.003) and in the fluticasone furoate group from 0.43 to 0.36 (p = 0.006) with comparable efficacy (p = 0.292). The prevalence of moderate-to-severe sleep apnea decreased from 67% to 41% with montelukast (p = 0.035) and from 81% to 60% with fluticasone furoate (p = 0.016). While both medications significantly reduced adenoid size (p < 0.001 and p < 0.001, respectively), only montelukast significantly reduced tonsillar size (p = 0.008).
Conclusions
Both montelukast and fluticasone furoate reduced the pediatric SDB severity. While both medications significantly decreased adenoid size, only montelukast significantly decreased tonsillar size. Therefore, fluticasone furoate may be appropriate for adenoid hypertrophy, while montelukast is favored for concurrent tonsillar hypertrophy. These treatments may serve as alternatives to surgery in selected cases. Further studies are needed to evaluate their long-term efficacy.
Objective: To compare the efficacy of inhaler corticosteroids and oral montelukast in children with reactive airways disease. Study Design: Randomized Controlled Trial. Setting: Department of Pediatrics, Lady Reading Hospital, Peshawar. Period: 20 July 2025 to 20 January 2026. Methods: A total of 60 children aged 1 to 5 year with reactive airway disease for more than 3 months were enrolled using a 95% confidence level and 80% power calculation. Participant were randomized into two equal groups of 30 each. Group A received inhaler corticosteroids at 200 microgram per day and Group B received oral montelukast at 4 mg once daily in children below 1 year and 5 mg once daily in children above 1 year. Efficacy was defined as complete absence of symptom after 3 months of treatment. Chi-square test and Fischer exact test were applied to compare efficacy between groups and across stratified variables. Results: Inhaler corticosteroids showed efficacy in 73.3% patients compared to 33.3% with oral montelukast (p=0.002). Age-stratified analysis showed significant efficacy in children aged 3 years or less (77.8% versus 40.0%, p=0.041). Female gender demonstrated superior response to inhaler corticosteroids (84.6% versus 35.3%, p=0.012). Urban residents showed better efficacy with inhaler corticosteroids (76.5% versus 31.3%, p=0.007). Conclusion: Inhaler corticosteroids are significantly more effective than oral montelukast in managing reactive airways disease in children.
Faiqa Shah, Afzal Khan, F. Riaz et al.· The Professional Medical Jou...· 0 citations
OBJECTIVE
To evaluate the safety and clinical improvements with once daily fixed dose combination (FDC) of montelukast 10 mg and acebrophylline sustained-release 200 mg tablet in patients with asthma.
METHODS
This multicenter, single-arm, open-label, prospective, phase IV clinical trial included adult patients with moderate to severe asthma. Patients meeting eligibility criteria based on GINA guidelines were included. They underwent a washout before initiating the 12-week treatment. Study visits included screening and enrollment visits, and follow-ups on days 28, 56, and 84.The primary outcome was the incidence of adverse events (AEs), while secondary outcomes included changes in trough forced expiratory volume in one second (FEV1), forced vital capacity (FVC), Asthma Symptom Utility Index (ASUI) scores, and rescue medication use.
RESULTS
A total of 211 patients with asthma were included. The mean ± SD age and body mass index (BMI) were 39.52 ± 11.68 years and 23.83 ± 4.37 kg/m2, respectively. AEs were reported in 10.9% of patients, and most AEs were of mild severity. One serious AE, unrelated to treatment, resulted in treatment withdrawal. Lung function showed significant improvement, with mean changes from baseline to Day 84 of 0.61 ± 0.56 L in FEV1, 0.51 ± 0.65 L in FVC, and 0.17 ± 0.14 in ASUI scores (p < 0.0001 for all). Rescue medication use decreased progressively, with fewer patients requiring it by Day 84.
CONCLUSION
The findings demonstrate that the FDC of montelukast and acebrophylline has a favorable safety profile and is associated with improvements in lung function and asthma symptoms.Trial registration: CTRI/2020/02/023237 [Registered on: 11/02/2020] Trial Registered Prospectively, URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzY1MjU=&Enc=&userName=.
Rakhi Ludam, Mayank Agrawal, K. M. Patel et al.· Journal of Asthma· 0 citations
Introduction.
Eczema is a common inflammatory skin disease characterized by pruritus, impaired quality of life, and the need for safe anti-inflammatory therapy.
Aim.
To evaluate the safety and efficacy of two cream formulations containing methylprednisolone aceponate in patients with uncomplicated eczema.
Materials and methods.
A postmarketing, open-label, comparative, randomized, parallel-group, phase IV study was conducted at three study sites in the Russian Federation. The study population included patients aged 18–70 years with acute or subacute uncomplicated idiopathic eczema affecting no more than 10% of the body surface area. 228 patients were randomised to receive either Komfoderm® K (n = 114) (intervention group) or Advantan® (n = 114) (comparator group). The drugs were applied topically once daily for 2 weeks, with follow-up period of 21 ± 2 days. The primary endpoint was the overall rate of adverse events over 3 weeks. The secondary endpoints included changes in the EASI, the pruritus intensity on VAS (100-mm line), the DLQI, and the sum of 7 eczema symptom scores.
Results.
Any adverse event was reported in 4/114 patients (3.5%; 95% CI 1.0–8.7) in the intervention group and 3/114 (2.6%; 95% CI 0.5–7.5) in the comparator group; no statistically significant differences between the groups (p > 0.999). All adverse events were defined as mild, non-serious, and not related to both drugs. By day 14, differences in LS-mean percentage change in EASI score was 2.42% (95% CI -1.17; 6.02), which met the criterion for comparable efficacy. Intergroup differences in EASI, VAS, DLQI, and 7 symptoms scores were not statistically significant.
Conclusions.
Both drugs demonstrated a favourable safety profile and comparable clinical efficacy in the 2-week treatment of uncomplicated idiopathic eczema. The patented ceramide-based formulation can be considered as an additional pharmaceutical characteristic of the drug in line with the targets to restore the epidermal barrier.
O. Zhukova, A. A. Khaldin, E. Malyarenko et al.· Meditsinskiy sovet = Medical...· 0 citations
Introduction: Oral antibiotics are effective for inflammatory acne but prolonged use contributes to antimicrobial resistance. Spironolactone offers a nonantibiotic systemic alternative for adult women, although comparative efficacy and concerns about menstrual irregularity and hyperkalemia influence prescribing. Objective: To compare spironolactone with doxycycline for moderate acne in adult women and evaluate menstrual and potassium-related safety. Methods: Seven bibliographic and trial registries were searched through August 10, 2026. Because fewer than ten directly comparative studies were found from 2021 onward, the search was extended to January 2016. Randomized comparisons and complementary spironolactone safety cohorts were appraised with RoB 2 or ROBINS-I, and evidence certainty was assessed using GRADE. Results and Discussion: Six primary studies were included. The FASCE randomized trial was the only head-to-head comparison and found that spironolactone plus benzoyl peroxide was slower initially but superior to doxycycline plus benzoyl peroxide by months 4 and 6. The SAFA trial independently confirmed increasing benefit through 24 weeks. Menstrual irregularity was clinically relevant but was often manageable and less frequent with combined oral contraception. Hyperkalemia was rare in healthy women aged 45 years or younger and more important with older age, renal or cardiovascular disease, and interacting medication. Conclusion: For appropriately selected adult women with moderate persistent acne, spironolactone is an effective antibiotic-sparing alternative and may outperform doxycycline over six months. Baseline risk assessment, pregnancy prevention counseling, and selective rather than universal potassium monitoring provide the most proportionate safety strategy.
Marisa Peçanha De Barros, Júlia Vitória Medeiro Birtche, Pedro Yuri Da Silveira et al.· Revista de Geopolítica· 0 citations
Background and Objectives: Acute rhinosinusitis is associated with a substantial deterioration in quality of life, including symptoms such as nasal obstruction, facial pressure, cough, and sleep disruption. Growing interest in non-pharmacological management strategies has been observed, particularly among populations in whom systemic treatments may be limited, such as pediatric patients and pregnant individuals. NESOSPRAY HE-G is a nasal device containing a filmogenic glycerol formulation designed to create a protective barrier and induce an osmotic effect, thereby promoting nasal decongestion and mucosal protection. Materials and Methods: A randomized, double-blind, placebo-controlled study was conducted to assess the performance and safety of NESOSPRAY HE-G (n = 20) compared with a saline comparator (n = 20) in patients aged 3 years and older presenting with acute rhinosinusitis and a baseline Rhino-Sinusitis Severity Score (RSSS) of at least 25/50. The investigational product was administered as three sprays per nostril, four times daily, over a maximum period of 15 days or until symptom resolution. Efficacy was primarily evaluated through changes in the total RSSS and in key symptoms, including nasal congestion, facial pain, cough, sleep disturbance, and fever. Safety assessments included monitoring adverse events (AE) and evaluating local tolerability. Results: Baseline characteristics were comparable between groups. Treatment with NESOSPRAY HE-G resulted in a statistically significant reduction in total RSSS from Day 2 onwards, with sustained effects throughout the study period. Improvements were also observed across individual symptoms, including early relief of nasal congestion and reductions in cough and facial pain, with faster onset compared to the comparator. Sleep quality showed progressive improvement. Resolution of fever occurred in both groups, with an earlier effect observed in the NESOSPRAY HE-G arm. No serious adverse events (SAE) or hypersensitivity reactions were reported. The product demonstrated good tolerability. Conclusions: NESOSPRAY HE-G provides rapid and sustained alleviation of symptoms associated with acute rhinosinusitis. Its topical mode of action, based on osmotic activity and barrier formation, represents a suitable non-pharmacological option, particularly for patients seeking alternatives to systemic therapies or presenting contraindications to such treatments.
OBJECTIVE
To evaluate the efficacy and safety of Ranquilon1 at 6 mg daily, compared with Afobazol (fabomotizole) at 30 mg daily, for the treatment of patients with anxiety associated with neurasthenia and adjustment disorders.
MATERIAL AND METHODS
The clinical study included 200 patients diagnosed with anxiety associated with neurasthenia (F48.0) or adjustment disorder (F43.2). All participants had a Hamilton Anxiety Rating Scale (HARS) score of 18-24, demonstrated significant asthenia on the Multidimensional Fatigue Inventory (MFI-20) (score over 50), and scored at least 4 on the Clinical Global Impression-Severity (CGI-S) subscale. Participants were randomly assigned to two groups: Group 1 consisted of 100 patients receiving Ranquilon 1 mg tablets at 6 mg/day (2 tablets three times daily) for 28 days, while Group 2 consisted of 100 patients receiving Afobazol (fabomotizole) 10 mg tablets at 30 mg/day (1 tablet three times daily) for the same duration. The assessment of therapeutic response used the HARS, the Psychological Stress Measure (PSM-25) to evaluate stress levels, the MFI-20 scale to assess asthenia, and the CGI-S subscale to assess the severity of the condition. Monitoring for adverse events (AEs), serious adverse events (SAEs), and clinically significant changes in vital signs, laboratory tests, and ECG parameters was used for safety assessment.
RESULTS
The proportion of responders with a 50% or greater reduction in mean HARS scores at Visit 3 (Day 29±1) compared to baseline (Visit 0) was statistically higher (p<0.043) in Group 1 (63.3%, n=62) vs. Group 2 (49.0%, n=49). All secondary efficacy criteria further demonstrated statistically significant advantages for Group 1 compared to Group 2 (p<0.05). In total, 29 AEs were reported in 14.0% (n=44) of patients, including 16 AEs in 16.0% (n=16) of patients from Group 1 and 13 AEs in 12.0% (n=12) of patients from Group 2. There was no significant difference between the treatment groups in the number of patients with AEs (p=0.4150). Both groups reported only mild AEs, with none serious, severe, or fatal, and none leading to discontinuation of study treatment. No clinically significant abnormalities were observed in vital signs, laboratory tests, or ECG assessments.
CONCLUSION
Ranquilon 1 mg tablets at 6 mg/day demonstrate greater efficacy than Afobazol 10 mg tablets at 30 mg/day in alleviating anxiety associated with neurasthenia and adjustment disorders. The safety profile of Ranquilon is favorable and comparable to that of Afobazol.
T. A. Karavayeva, A. Barinov, I. V. Egorov et al.· Zhurnal Nevrologii i Psikhia...· 0 citations
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