Effect of Symbicort on Sleep Quality in Patients With Emphysema

Phase 3

• Conditions: Emphysema; Poor Sleep Quality
• Interventions: Drug: Budesonide/formoterol; Drug: Placebo

• Registration Number: NCT01602523
• Lead Sponsor: Temple University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-05-18
• Study First Posted: 2012-05-21
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-07
• Primary Completion: 2014-04
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
budesonide/formoterol	Budesonide/formoterol	budesonide/formoterol 160/4.5 mcg (Symbicort)
Placebo	Placebo	Symbicort placebo

Primary Outcome Measures

Name	Time	Method
The primary outcome is the objective assessment of sleep quality.	28 days	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 Measures

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

Trial Locations

Locations (1)

Temple Lung Center; 🇺🇸 Philadelphia, Pennsylvania, United States