Background: Fluticasone propionate was introduced in 1993 in the UK as a potentially safer inhaled corticosteroid than those already in use. The efficacy and safety of fluticasone has been established at recommended doses of 200 micrograms/day, but not at higher doses that are often used.
Methods: Growth retardation was observed in six severely asthmatic children after introduction of high-dose fluticasone propionate treatment (dry powder). Assessment of cortisol response was by insulin-induced hypoglycaemia in three cases, by short tetracosactrin test in two, and by low-dose tetracosactrin and 24-hour urinary cortisol/creatinine ratio in one.
Findings: Six children with growth retardation noted after treatment with high-dose fluticasone propionate were found to have adrenal suppression. In one case the growth rate and cortisol response returned to normal 9 months after the fluticasone dose was reduced to 500 micrograms/day.
Interpretation: When high doses of fluticasone propionate are used, growth may be retarded and adrenal suppression may occur.
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http://dx.doi.org/10.1016/s0140-6736(96)03339-9 | DOI Listing |
Front Pharmacol
January 2025
Respiratory Department, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.
Objective: Single inhaler triple therapy is widely used in Chronic Obstructive Pulmonary Disease (COPD) and asthma. This research aimed to analyze adverse events (AEs) associated with Budesonide/Glycopyrronium/Formoterol Fumarate (BUD/GLY/FOR) and Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).
Methods: This is a cross-sectional study.
Front Pharmacol
January 2025
Phase I Clinical Trial Site, Nanjing Gaoxin Hospital, Nanjing, Jiangsu, China.
Background: Fluticasone propionate is a synthetic trifluoro-substituted glucocorticoid, a highly selective glucocorticoid receptor agonist. Fluticasone propionate nebuliser suspensions is an inhaled corticosteroid with the low systemic bioavailability which provides a low risk (benefit outcome without the adverse effects that accompany systemically administered corticosteroids), referred as a first-line preventive agent for patients with persistent asthma. China has become one of the countries with the highest asthma mortality rate in the world in the past years.
View Article and Find Full Text PDFClin Pharmacol Drug Dev
January 2025
Department of Pharmacy, The Third Hospital of Changsha, Changsha, Hunan, People's Republic of China.
Fluticasone propionate nasal spray is widely regarded as a first-line therapy for allergic rhinitis. To establish bioequivalence between the test and reference products of fluticasone propionate nasal spray, an open-label, randomized, single-dose, and 2-sequence crossover study was conducted on 84 healthy Chinese subjects under fasting conditions to determine the pharmacokinetic bioequivalence of the 2 products. Following a single-dose administration (200 µg) of fluticasone propionate nasal spray, pharmacokinetic parameters, including maximum plasma concentration, area under the concentration-time curve from administration to the last measurable concentration, and area under the concentration-time curve from administration to infinity, exhibited similarity between the 2 products, with 90% confidence intervals for the test/reference ratios falling within the bioequivalence range of 80%-125%.
View Article and Find Full Text PDFJ Fluoresc
January 2025
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr Al-Aini Street, Cairo, 11562, Egypt.
Highly sensitive spectrofluorimetric methods were developed for the quantitative estimation of formoterol fumarate dihydrate (FFD) and fluticasone propionate (FP) in both authentic raw materials and marketed dosage forms using a micellar-enhanced spectrofluorimetric approach. The proposed methods are based on the determination of FP in the presence of FFD using the first derivative emission spectrofluorimetry. The peak amplitude of the emission spectra of the formed micellar fluorescence was measured at 465 nm after excitation at 236 nm (λ max of FP).
View Article and Find Full Text PDFACS Pharmacol Transl Sci
January 2025
Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA), Silver Spring, Maryland 20993, United States.
Current in vitro cell-based methods, relying on single cell types, have structural and functional limitations in determining lung drug permeability, which is a contributing factor affecting both local and systemic drug levels. To address this issue, we investigated a 3D human lung airway model generated using a cell culture insert, wherein primary human lung epithelial and endothelial cells were cocultured at an air-liquid interface (ALI). To ensure that the cell culture mimics the physiological and functional characteristics of airway tissue, the model was characterized by evaluating several parameters such as cellular confluency, ciliation, tight junctions, mucus-layer formation, transepithelial electrical resistance, and barrier function through assaying fluorescein isothiocyanate-dextran permeability.
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