Effect of Symbicort on Sleep Quality in Patients With Emphysema
This study is ongoing, but not recruiting participants.
Sponsor:
Temple University
Information provided by (Responsible Party):
Samuel Krachman, Temple University
ClinicalTrials.gov Identifier:
NCT01602523
First received: April 23, 2012
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Emphysema Poor Sleep Quality |
Drug: Budesonide/formoterol Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Temple University:
Primary Outcome Measures:
- 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 Measures:
- 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.
| Estimated Enrollment: | 40 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: budesonide/formoterol
budesonide/formoterol 160/4.5 mcg (Symbicort)
|
Drug: Budesonide/formoterol
Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
Other Name: Symbicort
|
|
Placebo Comparator: Placebo
Symbicort placebo
|
Drug: Placebo
Placebo inhaler once daily 28 days
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Samuel Krachman, Principal Investigator, Professor of Medicine, Temple University |
| ClinicalTrials.gov Identifier: | NCT01602523 History of Changes |
| Other Study ID Numbers: | 13383 |
| Study First Received: | April 23, 2012 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Temple University:
|
Emphysema COPD Sleep |
Additional relevant MeSH terms:
|
Emphysema Pulmonary Emphysema Pathologic Processes Lung Diseases Respiratory Tract Diseases Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013