Last reviewed · How we verify
NCT03098680: PRIME
A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
Phase 1 trial testing Albuterol Sulfate in Drug-Related Side Effects and Adverse Reactions in 18 participants. Terminated before completion.
29 February 2020
Quick facts
| Lead sponsor | Cambridge University Hospitals NHS Foundation Trust |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 18 |
| Start date | 24 April 2017 |
| Primary completion | 29 February 2020 |
| Estimated completion | 29 February 2020 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Albuterol Sulfate — full drug profile →
- Nicardipine Hydrochloride — full drug profile →
- Dobutamine Hydrochloride (Dobutamine Hydrochloride) — full drug profile →
- Phenylephrine Hydrochloride
- Verapamil Hydrochloride — full drug profile →
- Phentolamine Mesylate — full drug profile →
- Placebo
Conditions studied
- Drug-Related Side Effects and Adverse Reactions — all drugs for Drug-Related Side Effects and Adverse Reactions →
- Cardiovascular System Disease — all drugs for Cardiovascular System Disease →
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Who can join
18 and older, male only, with Drug-Related Side Effects and Adverse Reactions or Cardiovascular System Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Unwanted effects on the cardiovascular system is one of the most common causes of safety related discontinuation of a drug. This study aims to develop an in silico model of the human cardiovascular system that can be used to predict unwanted cardiovascular effects of drugs. This will be achieved through a drug administration study that will generate comprehensive pharmacokinetic and pharmacodynamic data following the administration of the following drugs, all known to have effects on the cardiovascular system. Half the participants will receive: Placebo, Salbutamol, Nicardipine, Dobutamine and the other half will receive Placebo, Phenylephrine, Verapamil, Phentolamine.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03098680
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Albuterol Sulfate
Trials testing the same drug.
- NCT05035862 — Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma · Phase 1 · terminated
- NCT03586544 — Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity · Phase 4 · terminated
- NCT03091504 — Evaluation on the Efficacy of Bronchodilator Nebulization Via High Flow Nasal Cannula · NA · completed
- NCT02969408 — A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and E · Phase 3 · completed
- NCT03480997 — Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD · Phase 1 · completed
Other recruiting trials for Drug-Related Side Effects and Adverse Reactions
Currently open trials in the same condition.
- NCT06427317 — Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment · recruiting
- NCT05951660 — Sex, Psychopharmacology, and Diabetes · NA · recruiting
Other Cambridge University Hospitals NHS Foundation Trust trials
Trials by the same sponsor.
- NCT07516496 — Metabolic Phenotyping in vEDS · recruiting
- NCT07129577 — Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury · not yet recruiting
- NCT05093231 — Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer · Phase 2 · recruiting
- NCT06555757 — Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation · not yet recruiting
- NCT06427694 — Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03098680 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cambridge University Hospitals NHS Foundation Trust
- Last refreshed: 22 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03098680.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing