Olodaterol hydrochloride Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 227

Clinical Trials

Numerous clinical trials spanning early to late phases have evaluated olodaterol hydrochloride, primarily investigating chronic obstructive pulmonary disease, asthma, and safety in healthy volunteers. Sponsored by pharmaceutical leaders such as Boehringer Ingelheim and GlaxoSmithKline alongside academic institutions, most studies are completed, although some were withdrawn, suspended, or terminated. Key late-phase investigations focused on long-term safety, lung function outcomes, and the comparative efficacy of daily inhaled regimens to optimize respiratory care.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07267130	TERMINATED	Chronic Obstructive Pulmonary Disease	Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.	2025-11-25	PHASE1
NCT07541378	SUSPENDED	COPD (Chronic Obstructive Pulmonary Disease)	Medical University of Bialystok	2024-03-11
NCT04994574	COMPLETED	Chronic Obstructive Pulmonary Disease	Yonsei University	2021-08-23
NCT04231214	COMPLETED	Chronic Obstructive Pulmonary Disease	Fraunhofer-Institute of Toxicology and Experimental Medicine	2020-01-28	PHASE4
NCT04223843	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2020-01-08	PHASE4
NCT03152149	COMPLETED	Chronic Obstructive Pulmonary Disease	University of Dundee	2017-06-01	PHASE4
NCT02682862	COMPLETED	Asthma	University of Dundee	2016-07-11	PHASE4
NCT03240575	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2017-08-14	PHASE4
NCT03673670	COMPLETED	COPD	Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA	2018-07-16	PHASE2
NCT03425617	COMPLETED	Chronic Obstructive Pulmonary Disease	Queen's University	2017-01-01	PHASE4
NCT03055988	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2017-03-29	PHASE4
NCT02812862	WITHDRAWN	COPD	RWTH Aachen University	2016-08	PHASE4
NCT02853123	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2016-09-22	PHASE4
NCT02969317	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2017-02-24	PHASE1
NCT02799784	COMPLETED	Pulmonary Disease, Chronic Obstructive	GlaxoSmithKline	2016-07-14	PHASE4
NCT02629965	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2016-02-12	PHASE3
NCT02296138	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2015-01-13	PHASE3
NCT02683109	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2016-03-08	PHASE4
NCT02085161	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2014-03	PHASE3
NCT01969721	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2013-10	PHASE3
NCT01964352	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2013-11	PHASE3
NCT02006732	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2013-11	PHASE3
NCT02030535	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2014-01	PHASE2
NCT01533935	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2012-02	PHASE3
NCT01533922	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2012-03	PHASE3
NCT01431287	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2011-09	PHASE3
NCT01696058	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2012-09	PHASE3
NCT01431274	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2011-09	PHASE3
NCT01536262	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2012-02	PHASE3
NCT01525615	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2012-02	PHASE3
NCT01694771	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2012-09	PHASE3
NCT01559116	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2012-03	PHASE3
NCT01703845	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2012-10	PHASE1
NCT01311661	COMPLETED	Asthma	Boehringer Ingelheim	2011-03	PHASE2
NCT01040793	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2010-01	PHASE3
NCT01040130	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2010-01	PHASE3
NCT01040403	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2010-01	PHASE2
NCT01040728	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2010-01	PHASE3
NCT01040689	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2010-01	PHASE3
NCT01013753	COMPLETED	Asthma	Boehringer Ingelheim	2010-02	PHASE2
NCT00793624	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2009-02	PHASE3
NCT00796653	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2009-01	PHASE3
NCT00782509	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2009-02	PHASE3
NCT00782210	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2008-11	PHASE3
NCT01153711	COMPLETED	Healthy; Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2010-05	PHASE1
NCT01153724	COMPLETED	Healthy; Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2010-05	PHASE1
NCT00932646	COMPLETED	Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2009-06	PHASE3
NCT00928668	COMPLETED	Asthma	Boehringer Ingelheim	2006-01	PHASE2
NCT01428622	WITHDRAWN	Asthma	Boehringer Ingelheim	2011-10	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-27)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olodaterol hydrochloride selectively binds to and activates beta-2 adrenergic receptors on airway smooth muscle cells, which stimulates intracellular adenylate cyclase and elevates cyclic adenosine monophosphate levels. This biochemical signaling cascade induces sustained bronchial smooth muscle relaxation, thereby effectively reducing airflow resistance and improving pulmonary function in patients suffering from 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>).