NCT03067701

Effects of Carbon Monoxide Breathing on Blood Vessel Function

Completed Phase 1 Last updated 1 April 2019

What this trial tests

Phase 1 trial testing Carbon Monoxide in Endothelial Dysfunction in 9 participants. Completed in 1 March 2019.

Timeline

23 June 2017

Primary endpoint
1 December 2018

1 March 2019

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	9
Start date	23 June 2017
Primary completion	1 December 2018
Estimated completion	1 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Carbon Monoxide — full drug profile →

Conditions studied

• Endothelial Dysfunction — all drugs for Endothelial Dysfunction →

Sponsor

Cedars-Sinai Medical Center

Who can join

Adults 18 to 39, any sex, with Endothelial Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In healthy young adults 18-39 years of age, the investigators will determine if intermittent inhalation a 0.1% CO, from a 1-liter bag once every minute for 30-40 minutes, at a level that approaches the CO boost with hookah smoking, augments endothelial function, thus implicating CO as the major endothelial vasodilator substance in hookah smoke.

Rationale: Our group has demonstrated (PRO36547) that in contrast to cigarette smoking, hookah smoking (tobacco heated with charcoal) acutely augments, rather than impairs, brachial artery FMD. Importantly, our data strongly implicate-but do not prove-that the augmentation in FMD is caused by CO. Therefore; the investigators would like to extend the scientific priority of this work by directly investigating cause and effect of CO breathing (similar levels than ones obtained after hookah smoking) on brachial artery FMD.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Carbon Monoxide: from Poison to Clinical Trials.
   Siracusa R, Schaufler A, Calabrese V, Fuller PM, et al · · 2021 · cited 57× · PMID 33781582 · DOI 10.1016/j.tips.2021.02.003
2. Carbon Monoxide as a Potential Therapeutic Agent: A Molecular Analysis of Its Safety Profiles.
   Bansal S, Liu D, Mao Q, Bauer N, et al · · 2024 · cited 44× · PMID 38864348 · DOI 10.1021/acs.jmedchem.4c00823
3. Carbon Monoxide and Nitric Oxide as Examples of the Youngest Class of Transmitters.
   Nowaczyk A, Kowalska M, Nowaczyk J, Grześk G. · · 2021 · cited 40× · PMID 34199647 · DOI 10.3390/ijms22116029
4. Nature's marvels endowed in gaseous molecules I: Carbon monoxide and its physiological and therapeutic roles.
   Yang X, Lu W, Hopper CP, Ke B, et al · · 2021 · cited 28× · PMID 34221861 · DOI 10.1016/j.apsb.2020.10.010
5. High Carbon Monoxide Levels from Charcoal Combustion Mask Acute Endothelial Dysfunction Induced by Hookah (Waterpipe) Smoking in Young Adults.
   Rezk-Hanna M, Mosenifar Z, Benowitz NL, Rader F, et al · · 2019 · cited 24× · PMID 30764644 · DOI 10.1161/circulationaha.118.037375