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Corticosteroid

budesonide/formoterol for Insomnia

Phase 3
Waitlist Available
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate to severe emphysema (GOLD stages 2 and 3)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study 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.

Eligible Conditions
  • Insomnia
  • Emphysema

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The is the objective assessment of sleep quality.
Secondary outcome measures
includes assessment of nocturnal oxygenation.
includes assessment of overall quality of life.
includes assessment respiratory mechanics/function.
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: budesonide/formoterolActive Control1 Intervention
budesonide/formoterol 160/4.5 mcg (Symbicort)
Group II: PlaceboPlacebo Group1 Intervention
Symbicort placebo

Find a Location

Who is running the clinical trial?

Temple UniversityLead Sponsor
296 Previous Clinical Trials
82,755 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Apr 2025