Effect of Symbicort on Sleep Quality in Patients With Emphysema
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedDecember 7, 2012
December 1, 2012
3.1 years
April 23, 2012
December 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Secondary outcome includes assessment of nocturnal oxygenation.
28 days
Secondary outcome is the subjective assessment of sleep quality.
28 days
Secondary outcome includes assessment respiratory mechanics/function.
28 days
Secondary outcome includes assessment of overall quality of life.
28 days
Study Arms (2)
budesonide/formoterol
ACTIVE COMPARATORbudesonide/formoterol 160/4.5 mcg (Symbicort)
Placebo
PLACEBO COMPARATORSymbicort placebo
Interventions
Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
Eligibility Criteria
You may qualify if:
- Moderate to severe emphysema (GOLD stages 2 and 3)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Temple Lung Center
Philadelphia, Pennsylvania, 19140, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Professor of Medicine
Study Record Dates
First Submitted
April 23, 2012
First Posted
May 21, 2012
Study Start
March 1, 2011
Primary Completion
April 1, 2014
Study Completion
August 1, 2014
Last Updated
December 7, 2012
Record last verified: 2012-12