Effect of Symbicort on Sleep Quality in Patients With Emphysema
Recruitment status was Active, not recruiting
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.
Poor Sleep Quality
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Symbicort on Sleep Quality in Patients With Emphysema|
- The primary outcome is the objective assessment of sleep quality. [ Time Frame: 28 days ] [ Designated as safety issue: No ]Sleep quality will be assessed quantitatively by polysomnogram and include measurement of sleep efficiency (total sleep time/time in bed), total sleep time, and arousal index during the night. Subjective sleep quality and assessment of daytime function will be measured using the Pittsburgh sleep quality index (PSQI) and the Epworth Sleepiness scale (ESS), respectively.
- Secondary outcome includes assessment of nocturnal oxygenation. [ Time Frame: 28 days ] [ Designated as safety issue: No ]Nocturnal oxygenation will be measured by pulse oximetry.
- Secondary outcome is the subjective assessment of sleep quality. [ Time Frame: 28 days ] [ Designated as safety issue: No ]Quality of life will be assessed by SF-36 and SGRQ-C scores.
- Secondary outcome includes assessment respiratory mechanics/function. [ Time Frame: 28 days ] [ Designated as safety issue: No ]Respiratory function will be assessed by spirometry performed before sleep onset and upon awakening.
- Secondary outcome includes assessment of overall quality of life. [ Time Frame: 28 days ] [ Designated as safety issue: No ]Quality of life will be assessed by SF(short form)-36 and SGRQ-C(ST George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease patients)scores.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: budesonide/formoterol
budesonide/formoterol 160/4.5 mcg (Symbicort)
Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
Other Name: Symbicort
Placebo Comparator: Placebo
Placebo inhaler once daily 28 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602523
|United States, Pennsylvania|
|Temple Lung Center|
|Philadelphia, Pennsylvania, United States, 19140|