Effect of Symbicort on Sleep Quality in Patients With Emphysema

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Emphysema, Poor Sleep Quality

In brief

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.

Key facts

Study ID

NCT01602523

Run by

Temple University

People needed

40

Starts

2011-03-01

Expected to finish

2014-08-01

Last updated by the study team

2012-12-07

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe emphysema (GOLD stages 2 and 3)

You may not qualify if…

• Use of supplemental oxygen,
• A recent COPD exacerbation within the past 4 weeks.
• A previous diagnosis of obstructive sleep apnea
• A known urinary outflow obstruction,
• Glaucoma
• History of an allergic reaction to one of the study medications.

Where it is running

• Temple Lung Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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