fluticasone furoate Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 297

Clinical Trials

Multiple clinical trials sponsored by GlaxoSmithKline have evaluated fluticasone furoate across respiratory and inflammatory conditions, including chronic obstructive pulmonary disease, asthma, and rhinitis. All of these studies have achieved completed status and span Phase I and Phase III clinical trials. Early-stage pharmacokinetic and safety assessments examined single and repeat combination dosing regimens, while a clinical trial evaluated the safety and clinical profile of the compound in pediatric subjects affected by perennial allergic rhinitis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02064504	Completed	Pulmonary Disease Chronic Obstructive	GlaxoSmithKline	2014-02-19	Phase 1
NCT01622231	Completed	Rhinitis	GlaxoSmithKline	2012-06	Phase 3
NCT01266980	Completed	Pulmonary Disease Chronic Obstructive	GlaxoSmithKline	2010-11-18	Phase 1
NCT01266941	Completed	Asthma	GlaxoSmithKline	2010-10-18	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the fluticasone furoate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluticasone furoate selectively binds the glucocorticoid receptor with high affinity, prompting nuclear translocation to inhibit pro-inflammatory transcription factor activity and suppress downstream cytokine production. This suppression reduces mucosal inflammation and airway hyperresponsiveness, providing therapeutic efficacy across clinical conditions including chronic obstructive pulmonary disease, rhinitis, and asthma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).