drugset / Trial / NCT01602523

Effect of Symbicort on Sleep Quality in Patients With Emphysema

NCT01602523

Phase 3 Unknown 40 enrolled Temple University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an inhaled medication that contains 2 drugs. One is a medication that opens up the airways (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort is not an experimental medication. It is approved by the Food and Drug Administration for use in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening the airways and reducing lung inflammation. It is not known for sure if these effects actually improve sleep and quality of life. It is hoped that this study will answer this question.

Timeline

Start
2011-03
Primary completion
2014-04
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 160 ug Inhaled
Comparator Formoterol Other / unclassified 4.5 ug Inhaled

Indications