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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
Placebo inhaler once daily 28 days
Temple Lung Center
Philadelphia, Pennsylvania, United States
The primary outcome is the objective assessment of sleep quality.
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.
Time frame: 28 days
Secondary outcome includes assessment of nocturnal oxygenation.
Nocturnal oxygenation will be measured by pulse oximetry.
Time frame: 28 days
Secondary outcome is the subjective assessment of sleep quality.
Quality of life will be assessed by SF-36 and SGRQ-C scores.
Time frame: 28 days
Secondary outcome includes assessment respiratory mechanics/function.
Respiratory function will be assessed by spirometry performed before sleep onset and upon awakening.
Time frame: 28 days
Secondary outcome includes assessment of overall quality of life.
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.
Time frame: 28 days
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