Effect of Symbicort on Sleep Quality in Patients With Emphysema

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602523

Locations
United States, Pennsylvania
Temple Lung Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
  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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Budesonide
Formoterol
Symbicort
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
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 August 26, 2014