drugset / Trial / NCT01554488

Inhaled Fluticasone Effects on Upper Airway Patency in Obstructive Lung Disease

NCT01554488

Phase 4 Terminated 25 enrolled VA Office of Research and Development
RandomizedParallel-groupOpen-labelOther

Summary

The Chairman of the Veterans' Disability Benefits Commission reported at a recent US Senate hearing that asthma, chronic obstructive pulmonary disease (COPD), and sleep apnea are among the top 13 most frequent diagnoses leading to disability under the Department of Defense and the VA system statutes. Recent research finds that sleep apnea is more common among asthma and COPD individuals, and this may be caused by inhaled corticosteroid use. Many Veterans are currently using inhaled corticosteroids, and many more will be prescribed such medications, given their recent inclusion in international treatment guidelines. As such, this study addresses a critical need by researching the role of a potent inhaled corticosteroid in promoting sleep apnea, the determinants of this response, and the ways through which it occurs. Results from this study will form the foundation for future research aimed at expanding understanding of the effects of inhaled corticosteroids on the upper airway, as well as developing means to prevent or counteract them.

Timeline

Start
2013-03-12
Primary completion
2016-02-03
Completion
2016-04-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 44 ug Inhaled
Subject Fluticasone propionate Other / unclassified 220 ug Inhaled