Olodaterol Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 357

Clinical Trials

Several completed clinical trials have evaluated olodaterol to assess its clinical utility, pharmacokinetic profile, and real-world drug utilization in subjects with chronic obstructive pulmonary disease and healthy volunteers. Sponsored by organizations including Boehringer Ingelheim and RTI Health Solutions US, these studies encompassed Phase 1 protocols and post-marketing observational research. Key investigations focused on fixed-dose combination delivery, safety parameters, and real-world prescribing patterns.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03030638	Completed	Pulmonary Disease Chronic Obstructive	Boehringer Ingelheim\|RTI health solutions US	2017-02-08	--
NCT02969317	Completed	Pulmonary Disease Chronic Obstructive	Boehringer Ingelheim	2017-02-24	Phase 1
NCT02172118	Completed	Healthy	Boehringer Ingelheim	2009-08	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olodaterol selectively binds to and activates β2-adrenergic receptors, triggering adenylyl cyclase stimulation and increasing intracellular cyclic adenosine monophosphate levels. This signaling cascade promotes airway smooth muscle relaxation and sustained bronchodilation, effectively relieving airflow obstruction 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>).