Tiotropium Bromide hydrate Clinical Trials

Size	Price	Qty
5mg	USD 120

Clinical Trials

Multiple clinical trials evaluate tiotropium bromide across Phase 1, Phase 2, and Not Applicable designations, with recruitment statuses including completed and actively recruiting. Sponsored by diverse entities such as Orion Pharma, Nemours Children's Clinic, the Guangzhou Institute of Respiratory Disease with Boehringer Ingelheim, and the National University of Malaysia, these studies involve healthy volunteers, pediatric asthma, and chronic obstructive pulmonary disease. Specific protocols investigate pharmacokinetic profiles, comparative treatment regimens, administration devices, and small airway remodeling.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05246046	Completed	Healthy Volunteers	Orion Corporation Orion Pharma	2022-02-16	Phase 1
NCT04990167	Recruiting	Asthma in Children	Nemours Children''s Clinic	2022-01-01	Phase 2
NCT05295355	Recruiting	Chronic Obstructive Pulmonary Disease	Guangzhou Institute of Respiratory Disease\|Boehringer Ingelheim	2021-01-25	Not Applicable
NCT04999930	Completed	Chronic Obstructive Pulmonary Disease	National University of Malaysia	2020-01-10	Not Applicable

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

Check the Tiotropium Bromide hydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tiotropium Bromide hydrate acts as a muscarinic receptor antagonist that targets and binds M3 muscarinic receptors on smooth muscle cells and submucosal glands, blocking downstream cholinergic signaling pathways to inhibit smooth muscle contraction and excessive mucus secretion. This cellular inhibition produces prolonged bronchodilation, providing therapeutic relevance for clinical applications in chronic obstructive pulmonary disease and pediatric 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>).