Background: This randomized, double-blind, multicenter study was designed to evaluate the efficacy of inhaled once-daily fluticasone furoate (FF) administered in the evening in patients with persistent asthma not controlled by short-acting beta(2) agonists, and to determine the dose(s) suitable for further development.
Methods: Of 1459 patients screened, 598 received one of six treatments: placebo, FF (25 μg, 50 μg, 100 μg or 200 μg) once daily each evening, or fluticasone propionate (FP) 100 μg twice daily for 8 weeks. The primary endpoint was change from baseline in pre-dose evening forced expiratory volume in 1 s (FEV(1)).
Results: A dose-response effect was observed for once-daily FF 25-200 μg including (p < 0.001) and excluding placebo (p = 0.03). FF 50-200 μg once daily significantly increased FEV(1) from baseline (p < 0.05 vs placebo), by >200 mL for FF 100 μg and 200 μg. Significant improvements were also achieved for peak expiratory flow, and percentage symptom-free and rescue-free 24 h periods. The magnitude of effect was at least as good as twice-daily FP. Overall, once-daily FF was well tolerated with no systemic corticosteroid effects.
Conclusion: FF 50-200 μg/day once daily in the evening demonstrated dose-related efficacy in asthma with 100-200 μg appearing to be the optimal doses for further evaluation. ClinicalTrials.gov: NCT00603382.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.rmed.2012.01.004 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Adherence and Persistence with Single-Inhaler Triple Therapy Among Patients with COPD Using Commercial and Medicare Advantage US Health Plan Claims Data.
Adv Ther
December 2024
US Value Evidence and Outcomes, R&D Global Medical, GSK, Collegeville, PA, 19426-0989, USA.
Article Synopsis
- This study examines how well patients with chronic obstructive pulmonary disease (COPD) stick to their medication regimens, comparing a single daily inhaler (FF/UMEC/VI) to a combination that requires two inhalations twice a day (BUD/GLY/FOR).
- Using insurance claims data from 2019 to 2023, researchers evaluated adherence (how often patients take their medication) and persistence (how long they continue treatment), with a total of 11,597 COPD patients involved.
- Results showed that patients using the single inhaler (FF/UMEC/VI) had better adherence and persistence over 6 and 12 months compared to those using the combination
A Multicenter Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of a 1-Year Regimen of Orally Inhaled Fluticasone Furoate 50 ug Once Daily on Growth Velocity in Prepubertal, Pediatric Participants With Well-Controlled Asthma.
Pediatrics
December 2024
Norfolk, Virginia.
Improvement of CPAP tolerance and adherence in a patient with obstructive sleep apnea with the use of nasal steroids and nasal oxymetazoline.
J Clin Sleep Med
November 2024
Indiana University School of Medicine, Department of Internal Medicine, Division of General Internal Medicine.
Adherence to positive airway pressure (PAP) therapy is a challenge in patients with allergic rhinitis. We present a case of a 62-year-old male with OSA who had been struggling with PAP therapy for ten years. Intranasal fluticasone alone did not result in tolerance of PAP therapy.
View Article and Find Full Text PDFComparison of Budesonide/formoterol versus Fluticasone furoate/vilanterol as maintenance and reliever therapy for asthma control: a real-world observational study.
BMC Pulm Med
August 2024
Division of Pulmonary and Critical Care, Department of Internal Medicine, North District, China Medical University Hospital, No. 2, Yude Road, Taichung City, 40402, Taiwan.
Article Synopsis
- A study examined the effectiveness of fluticasone furoate and vilanterol (FF/VIL) compared to budesonide/formoterol (BUD/FOR) in asthma patients classified as step 3 or 4 according to treatment guidelines.
- After 12 months, those on FF/VIL reported greater improvements in asthma control test (ACT) scores than those on BUD/FOR, who showed no significant change in their fractional exhaled nitric oxide (FeNO) levels.
- Despite variations in ACT and FeNO results, neither treatment group showed meaningful changes in pulmonary function, blood eosinophil count, or acute asthma exacerbation rates.
Once-daily fluticasone furoate/vilanterol vs once-daily fluticasone furoate in patients with asthma aged 5 to 17 years.
Ann Allergy Asthma Immunol
November 2024
Alergo-Med Specialist Medical Clinic, Tarnów, Poland.
Background: Limited data exist comparing inhaled corticosteroid (ICS) plus adjunctive therapy vs ICS alone in pediatric asthma patients.
Objective: To evaluate the efficacy and safety of fluticasone furoate/vilanterol (FF/VI) vs FF in children and adolescents with asthma.
Methods: This phase 3, randomized, double-blind, multicenter study (NCT03248128) included participants aged 5 to 17 years with six months or more asthma history uncontrolled on ICS monotherapy.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!