Effect of Symbicort on Sleep Quality in Patients With Emphysema

December 6, 2012 updated by: Samuel Krachman, Temple University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple Lung Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Symbicort
Placebo Comparator: Placebo
Symbicort placebo
Drug: Placebo
Placebo inhaler once daily 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome includes assessment of nocturnal oxygenation.
Time Frame: 28 days
Nocturnal oxygenation will be measured by pulse oximetry.
28 days
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.
28 days
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.
28 days
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

May 18, 2012

First Posted (Estimate)

May 21, 2012

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13383

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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