This trial is active, not recruiting.

Conditions emphysema, poor sleep quality
Treatments budesonide/formoterol, placebo
Phase phase 3
Sponsor Temple University
Start date March 2011
End date April 2014
Trial size 40 participants
Trial identifier NCT01602523, 13383


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
budesonide/formoterol 160/4.5 mcg (Symbicort)
budesonide/formoterol Symbicort
Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
(Placebo Comparator)
Symbicort placebo
Placebo inhaler once daily 28 days

Primary Outcomes

The primary outcome is the objective assessment of sleep quality.
time frame: 28 days

Secondary Outcomes

Secondary outcome includes assessment of nocturnal oxygenation.
time frame: 28 days
Secondary outcome is the subjective assessment of sleep quality.
time frame: 28 days
Secondary outcome includes assessment respiratory mechanics/function.
time frame: 28 days
Secondary outcome includes assessment of overall quality of life.
time frame: 28 days

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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.

Additional Information

Official title Effect of Symbicort on Sleep Quality in Patients With Emphysema
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Temple University.