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Effect of Symbicort on Sleep Quality in Patients With Emphysema

NCT ID: NCT01602523

Last Updated: 2012-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Emphysema Poor Sleep Quality

Keywords

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Emphysema COPD Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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budesonide/formoterol

budesonide/formoterol 160/4.5 mcg (Symbicort)

Group Type ACTIVE_COMPARATOR

Budesonide/formoterol

Intervention Type DRUG

Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days

Placebo

Symbicort placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo inhaler once daily 28 days

Interventions

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Budesonide/formoterol

Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days

Intervention Type DRUG

Placebo

Placebo inhaler once daily 28 days

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role lead

Responsible Party

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Samuel Krachman

Principal Investigator, Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Temple Lung Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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13383

Identifier Type: -

Identifier Source: org_study_id