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Effect of Symbicort on Sleep Quality in Patients With Emphysema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01602523
Recruitment Status : Unknown
Verified December 2012 by Samuel Krachman, Temple University.
Recruitment status was:  Active, not recruiting
First Posted : May 21, 2012
Last Update Posted : December 7, 2012
Information provided by (Responsible Party):
Samuel Krachman, 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.

Condition or disease Intervention/treatment Phase
Emphysema Poor Sleep Quality Drug: Budesonide/formoterol Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Symbicort on Sleep Quality in Patients With Emphysema
Study Start Date : March 2011
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The primary outcome is the objective assessment of sleep quality. [ Time Frame: 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 :
  1. Secondary outcome includes assessment of nocturnal oxygenation. [ Time Frame: 28 days ]
    Nocturnal oxygenation will be measured by pulse oximetry.

  2. Secondary outcome is the subjective assessment of sleep quality. [ Time Frame: 28 days ]
    Quality of life will be assessed by SF-36 and SGRQ-C scores.

  3. Secondary outcome includes assessment respiratory mechanics/function. [ Time Frame: 28 days ]
    Respiratory function will be assessed by spirometry performed before sleep onset and upon awakening.

  4. Secondary outcome includes assessment of overall quality of life. [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01602523

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United States, Pennsylvania
Temple Lung Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University

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Responsible Party: Samuel Krachman, Principal Investigator, Professor of Medicine, Temple University Identifier: NCT01602523     History of Changes
Other Study ID Numbers: 13383
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012

Keywords provided by Samuel Krachman, Temple University:

Additional relevant MeSH terms:
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Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists