Effect of Symbicort on Sleep Quality in Patients With Emphysema

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Symbicort on Sleep Quality in Patients With Emphysema

Conditions
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Emphysema, Poor Sleep Quality

Intervention / Treatment
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* Drug: Budesonide/formoterol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: budesonide/formoterol<br>budesonide/formoterol 160/4.5 mcg (Symbicort) | Drug: Budesonide/formoterol<br>* Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days<br>* Other names: Symbicort;|
| Placebo Comparator: Placebo<br>Symbicort placebo | Drug: Placebo<br>* Placebo inhaler once daily 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome includes assessment of nocturnal oxygenation. | Nocturnal oxygenation will be measured by pulse oximetry. | 28 days | 
| Secondary outcome is the subjective assessment of sleep quality. | Quality of life will be assessed by SF-36 and SGRQ-C scores. | 28 days | 
| Secondary outcome includes assessment respiratory mechanics/function. | Respiratory function will be assessed by spirometry performed before sleep onset and upon awakening. | 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. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emphysema, COPD, Sleep