Beclomethasone dipropionate Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple clinical trials evaluate beclomethasone dipropionate in Phase 3 and Phase 4 studies spanning therapeutic and athletic applications. Industry sponsor Teva Branded Pharmaceutical Products R&D Inc. completed a Phase 3 clinical trial assessing the safety and hypothalamic activity of a nasal aerosol formulation for allergic rhinitis. Furthermore, academic and institutional entities—including Western Norway University of Applied Sciences, The Norwegian School of Sport Sciences, and The Norwegian Doping Control Laboratory—sponsored a Phase 4 clinical trial investigating systemic detection and aerobic capacity in healthy athletes, which currently has an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05352191	Unknown status	Performance Detection\|Doping	Western Norway University of Applied Sciences\|The Norwegian School of Sport Sciences\|The Norwegian Doping Control Laboratory	2022-09-01	Phase 4
NCT01697956	Completed	Allergic Rhinitis	Teva Branded Pharmaceutical Products R&D Inc.	2012-10	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Beclomethasone dipropionate selectively binds to intracellular glucocorticoid receptors, subsequently repressing pro-inflammatory transcription factors and blocking downstream inflammatory cascade pathways. This cellular inhibition suppresses mucosal cytokine release and immune cell infiltration, mitigating localized tissue edema and mediating clinical efficacy in treating allergic rhinitis.

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>).