Clinical Trials

Multiple clinical trials spanning early phase 1 through phase 4 evaluate the pharmacological profile and therapeutic application of fenoterol across conditions including asthma, chronic obstructive pulmonary disease, bronchopulmonary dysplasia, pediatric airway obstruction, congestive heart failure, and thermogenesis. Supported by major pharmaceutical companies, academic bodies, and government institutions, these studies encompass completed, actively recruiting, terminated, and unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05183841 UNKNOWN
Bronchiectasis Adult
University of Sao Paulo General Hospital
 2022-04-14
NCT05294965 COMPLETED
Thermogenesis
University Hospital, Basel, Switzerland
 2022-04-27 EARLY_PHASE1
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 --
NCT02054299 COMPLETED
Drug Metabolism; Membrane Transport
University Medical Center Goettingen
 2013-04 PHASE1
NCT01440335 COMPLETED
Congestive Heart Failure
National Institute on Aging (NIA)
 2011-07-10 PHASE1
NCT00460577 COMPLETED
Acute Bronchial Obstruction, Asthma
Novartis
 2007-03 PHASE4
NCT00274066 COMPLETED
Pulmonary Disease, Chronic Obstructive
Boehringer Ingelheim
 2002-10 PHASE3
NCT02182505 COMPLETED
Asthma
Boehringer Ingelheim
 1998-09 PHASE3
NCT02182479 COMPLETED
Asthma
Boehringer Ingelheim
 1998-04 PHASE3
NCT02173782 COMPLETED
Pulmonary Disease, Chronic Obstructive
Boehringer Ingelheim
 1998-02 PHASE3
NCT02177370 TERMINATED
Asthma
Boehringer Ingelheim
 1990-02 PHASE3

(data from https://clinicaltrials.gov, updated on 2023-12-11)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fenoterol selectively binds to and activates β2-adrenergic receptors, stimulating adenylyl cyclase activity and increasing intracellular cyclic adenosine monophosphate levels. This signaling cascade leads to protein kinase A activation and subsequent airway smooth muscle relaxation, providing therapeutic bronchodilation directly relevant to clinical trial investigations in asthma, chronic obstructive pulmonary disease, and bronchopulmonary dysplasia.

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>).

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Note: Technical data last updated: Sep 1, 2026.