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Corticosteroid

Corticosteroids for Swallowing Difficulty (COPED Trial)

Phase 2
Recruiting
Led By Marc Moss, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admission to an ICU during their hospitalization
Mechanical ventilation with an endotracheal tube for greater than 48 hours
Must not have
Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding
Pre-existing history of dysphagia or aspiration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month post-hospital discharge

Summary

"This trial is testing the effectiveness of intravenous corticosteroids for Acute Respiratory Failure Survivors with laryngeal edema. The study will be double-blind, meaning neither the patients

Who is the study for?
This trial is for Acute Respiratory Failure Survivors who have been previously enrolled in an R01 cohort study and show laryngeal edema on their initial FEES exam. It's not specified who can't join, but typically there would be criteria excluding certain patients.
What is being tested?
The trial tests if a short course of intravenous corticosteroids (Methylprednisolone) helps with swallowing difficulties post-extubation compared to a placebo (Normal Saline). The study is blinded, meaning neither the doctors nor the patients know who gets the real drug or placebo.
What are the potential side effects?
Corticosteroids like Methylprednisolone may cause side effects such as increased blood sugar levels, mood swings, increased risk of infection, and high blood pressure. Placebos generally have no active ingredients so any side effects are usually psychological.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was admitted to the ICU during my hospital stay.
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I have been on a breathing machine with a tube for more than 2 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bleeding disorder causing uncontrolled nose or throat bleeding.
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I have a history of swallowing difficulties or inhaling food/liquid into my lungs.
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I cannot receive nutrition by mouth or feeding tube.
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I am on a high dose of corticosteroids daily.
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I or my doctor have decided not to participate.
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I have a muscle or nerve disorder.
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I have had head or neck cancer or surgery before.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post-hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month post-hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pre/post intervention change in the revised Patterson edema scale on FEES exam
Secondary study objectives
Change in Individual Components of the Revised Patterson Edema Scale
Change in the Penetration-Aspiration Scale (PAS) Score
Other study objectives
Post-Discharge 20-Item Medical Outcomes Study (MOS) Social Support Survey
Post-Discharge Caregiver Assistance Scale (CAS)
Post-Discharge Caregiving Impact Scale (CIS)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Corticosteroid InterventionExperimental Treatment1 Intervention
50 mg Methylprednisolone IV every 6 hours for 4 doses (total dose 200mg)
Group II: Placebo ControlPlacebo Group1 Intervention
Normal Saline placebo dose IV every 6 hours for 4 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
2015
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,797 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,252 Total Patients Enrolled
Marc Moss, MDPrincipal InvestigatorUniversity of Colorado, Denver
7 Previous Clinical Trials
1,649 Total Patients Enrolled
~53 spots leftby Nov 2026
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