NCT01602523

Effect of Symbicort on Sleep Quality in Patients With Emphysema

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emphysema
• Poor Sleep Quality

Interventions

Type	Name	Description
DRUG	Budesonide/formoterol	Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
DRUG	Placebo	Placebo inhaler once daily 28 days

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-04-01
• Completion: 2014-08-01
• First posted: 2012-05-21
• Last updated: 2012-12-07

Locations

1 site across 1 country: United States