Effect of Symbicort on Sleep Quality in Patients With Emphysema

Temple University

Status and phase: Unknown; Phase 3

Conditions: Poor Sleep Quality; Emphysema

Treatments: Drug: Placebo; Drug: Budesonide/formoterol

Study type: Interventional

Funder types: Other

Identifiers

NCT01602523

13383

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

budesonide/formoterol

Active Comparator group

Description:

budesonide/formoterol 160/4.5 mcg (Symbicort)

Treatment:

Drug: Budesonide/formoterol

Placebo

Placebo Comparator group

Description:

Symbicort placebo

Treatment:

Drug: Placebo