drugset / Trial / NCT03104634
The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers
Phase 3
Completed
43 enrolled
McGill University Health Centre/Research Institute of the McGill University Health Centre
RandomizedCrossoverQuadruple-blindTreatment
Summary
This short-term study aims to prove the potential cardio-protective physiological effect of inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures. Smoking is associated with gas-trapping (hyperinflation), even in the absence of chronic obstructive pulmonary disease. Breathing in the presence of gas-trapping requires large negative inspiratory pleural pressures, which are transmitted to the surface of the heart and increase cardiac wall stress. Inhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is unknown.
Timeline
- Start
- 2017-05-01
- Primary completion
- 2018-12-01
- Completion
- 2019-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclidinium | Small molecule | 400 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 12 ug | Inhaled |
Indications
No indication recorded.