Azelastine HCl Clinical Trials

Size	Price	Qty
100mg	USD 79

Clinical Trials

A completed Phase 2 clinical trial sponsored by GlaxoSmithKline evaluated the therapeutic efficacy of intranasal azelastine hydrochloride in patients with allergic rhinitis and seasonal allergic rhinitis. Using an allergen challenge model, the trial investigated repeat intranasal dosing of azelastine hydrochloride in combination with an investigational agent. Overall, the clinical trial demonstrates the targeted application of intranasal azelastine hydrochloride for modulating allergic responses and relieving seasonal rhinitis symptoms.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00612118	Completed	Allergic Rhinitis\|Rhinitis Allergic Seasonal	GlaxoSmithKline	2008-02	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Azelastine HCl selectively binds to histamine H1 receptors and stabilizes mast cell membranes, which blocks downstream histamine-mediated biochemical signaling and inhibits pro-inflammatory mediator release. This targeted suppression mitigates mucosal cell activation and vascular hyperpermeability, providing therapeutic symptom relief in clinical conditions such as 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>).