Aminophylline Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate aminophylline across diverse indications, including anesthesia brain monitoring during propofol administration, premature obstetric labor, and severe asthma. Sponsored by academic and healthcare entities such as the University of Padova, Action Medical Research, St Stephens Aids Trust, and the Royal Brompton & Harefield NHS Foundation Trust, these studies comprise Phase 1 and unclassified phase designations. Their recruitment statuses range from completed to unknown and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06134037	Completed	Anesthesia Brain Monitoring	University of Padova	2023-11-12	--
NCT06098196	Completed	Propofol\|Anesthesia Brain Monitoring	University of Padova	2023-10-25	--
NCT03152942	Unknown status	Premature Obstetric Labor	St Stephens Aids Trust\|Action Medical Research	2017-10-05	Phase 1
NCT02270827	Terminated	Asthma	Royal Brompton & Harefield NHS Foundation Trust	2014-06	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aminophylline acts as a competitive nonselective phosphodiesterase inhibitor and nonselective adenosine receptor antagonist, thereby blocking the enzymatic degradation of cyclic AMP and interfering with adenosine-mediated signaling cascades. The resulting elevation in intracellular cyclic AMP levels promotes airway smooth muscle relaxation and bronchodilation, which underlies its clinical evaluation for respiratory conditions such as severe asthma and smooth muscle modulation in premature obstetric labor.

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>).