Aclidinium Bromide Clinical Trials

Size	Price	Qty
10mg	USD 170

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate aclidinium bromide, focusing primarily on chronic obstructive pulmonary disease (COPD), chronic obstructive airway disease, smoking, and safety in healthy volunteers through Phase 2 pharmacokinetic and Phase 3 efficacy studies. Conducted by pharmaceutical sponsors such as AstraZeneca and Daewoong Pharmaceutical Co. LTD. alongside academic institutions including the University of Milan, University of Dundee, and Maastricht University Medical Center, most of these trials are completed, while others are listed as withdrawn, terminated, or unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03022097	COMPLETED	COPD	AstraZeneca	2017-02-02	PHASE3
NCT03276052	COMPLETED	Healthy Volunteers	AstraZeneca	2021-10-14	PHASE1
NCT03275116	UNKNOWN	Chronic Obstructive Airway Disease	Maastricht University Medical Center	2017-07-07	PHASE4
NCT02972476	COMPLETED	Chronic Obstructive Pulmonary Disease	University of Dundee	2016-12	PHASE4
NCT03181880	WITHDRAWN	Chronic Obstructive Pulmonary Disease	AstraZeneca	2017-12-04	PHASE4
NCT03104634	COMPLETED	Smoking	McGill University Health Centre/Research Institute of the McGill University Health Centre	2017-05-01	PHASE3
NCT02429765	COMPLETED	COPD	Queen's University	2015-10	PHASE4
NCT03276078	COMPLETED	Pulmonary Disease, Chronic Obstructive	AstraZeneca	2017-11-23	PHASE2
NCT03276078	Completed	Pulmonary Disease Chronic Obstructive	AstraZeneca	2017-11-23	Phase 2
NCT01966107	COMPLETED	COPD; Chronic Obstructive Pulmonary Disease; Moderate to Very Severe COPD	AstraZeneca	2013-10-16	PHASE4
NCT02796677	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2016-07-05	PHASE3
NCT02424344	COMPLETED	Pulmonary Disease, Chronic Obstructive	AstraZeneca	2015-04-27	PHASE4
NCT02375724	COMPLETED	Pulmonary Disease, Chronic Obstructive	AstraZeneca	2015-03	PHASE4
NCT02039050	COMPLETED	Pulmonary Disease, Chronic Obstructive	University of Dundee	2014-02	PHASE4
NCT02153489	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2014-04	PHASE4
NCT02181023	COMPLETED	Chronic Obstructive Pulmonary Disease	University of Milan	2014-06	PHASE4
NCT01908140	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2013-09	PHASE3
NCT01572792	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2012-04	PHASE3
NCT01636401	COMPLETED	COPD	Daewoong Pharmaceutical Co. LTD.	2012-08	PHASE3
NCT01437540	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2011-09-19	PHASE3
NCT01437397	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2011-09	PHASE3
NCT01462942	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2011-10	PHASE3
NCT01471171	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2011-11	PHASE3
NCT01462929	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2011-11	PHASE3
NCT01045161	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2009-03	PHASE3
NCT01044459	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2009-11	PHASE3
NCT01001494	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2009-10	PHASE3
NCT00970268	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2009-08	PHASE3
NCT01078623	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2010-02	PHASE2
NCT01120093	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2010-05	PHASE2
NCT01049360	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2009-12	PHASE2
NCT00891462	COMPLETED	Chronic Obstructive Pulmonary Disease	AstraZeneca	2009-04	PHASE3
NCT00868231	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2009-03	PHASE2
NCT00500318	COMPLETED	Pulmonary Disease, Chronic Obstructive	AstraZeneca	2007-07	PHASE3
NCT00706914	TERMINATED	Pulmonary Disease, Chronic Obstructive	AstraZeneca	2008-06-30	PHASE2
NCT00626522	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2008-02	PHASE2
NCT00358436	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2006-08	PHASE3
NCT00363896	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2006-07	PHASE3
NCT00435760	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	AstraZeneca	2007-02	PHASE3

(data from https://clinicaltrials.gov, updated on 2025-03-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aclidinium Bromide functions as a potent competitive antagonist that binds human muscarinic acetylcholine receptors M1 through M5 with sub-nanomolar affinity, thereby blocking downstream cholinergic signaling pathways and preventing intracellular calcium accumulation in airway smooth muscle cells. This inhibition leads to sustained relaxation of bronchial smooth muscle and localized bronchodilation, directly counteracting airflow obstruction and hyperinflation in patients with chronic obstructive pulmonary disease.

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>).