Ipratropium Bromide Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials evaluate ipratropium bromide across pediatric and respiratory indications, including exercise-induced bronchospasm in athletes, pediatric depression-related asthma, and bronchopulmonary dysplasia and bronchial hyperreactivity in preterm infants. Conducted across Early Phase 1, Phase 4, and unassigned phases, these studies are sponsored by academic and federal institutions such as Charles University, the University of California, San Francisco, and the State University of New York at Buffalo in collaboration with NCATS. Trial recruitment status ranges from currently recruiting to completed, encompassing both active and concluded evaluations of the drug's bronchodilatory efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06110481	Recruiting	Bronchopulmonary Dysplasia\|Chronic Lung Disease of Prematurity\|Chronic Lung Disease of Newborn\|Preterm Birth Complication\|Bronchial Hyperreactivity\|Bronchial Obstruction\|Reversible Dilatation	Charles University Czech Republic	2021-04-01	--
NCT04617015	Completed	Asthma\|Depression\|Childhood Asthma	State University of New York at Buffalo\|National Center for Advancing Translational Sciences (NCATS)	2016-09-09	Early Phase 1
NCT01691079	Completed	Bronchospasm Exercise-Induced	University of California San Francisco	2012-12	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ipratropium bromide selectively binds to and antagonizes M3 muscarinic acetylcholine receptors, thereby inhibiting acetylcholine-mediated cholinergic signaling and preventing parasympathetic signal transduction in airway smooth muscle cells. This pharmacological blockade relaxes bronchial smooth muscle tissue to induce bronchodilation, directly counteracting airway hyperreactivity and obstruction in clinical conditions such as chronic obstructive pulmonary disease, asthma, and exercise-induced bronchospasm.

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>).