DysphagiaPhase 2COPEDNCT06670521
Corticosteroids for Post-Extubation Dysphagia
A Phase 2 study testing Methylprednisolone and Normal Saline in people with Dysphagia and Laryngeal Edema, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a placebo-controlled, double-blind randomized trial of a short course of intravenous corticosteroids for Acute Respiratory Failure Survivors with Fiberoptic Endoscopic Evaluation of Swallowing (FEES) documented laryngeal edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Laryngeal Edema
- What is being tested?
- Methylprednisolone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant enrolled in primary study COMIRB #21-3873/ NCT # 05108896
- Laryngeal edema identified on participants primary study Fiberoptic Endoscopic Evaluation of Swallowing (FEES) as defined as a revised Patterson edema score greater than zero
- Admission to an ICU during their hospitalization
- Mechanical ventilation with an endotracheal tube for greater than 48 hours.
- Extubation except for compassionate extubation or transition to end-of-life care.
Who cannot join
- Patient or provider refusal
- Contraindication or corticosteroids defined as an allergic reaction (extremely rate) or taking other immunosuppressive medications.
- Chronic treatment with corticosteroids (>= 40 mg Prednisone/day, >=32 Methylprednisolone/day)
- Contraindication to enteral/oral nutrition administration.
- Pre-existing history of dysphagia or aspiration.
- Pre-existing or acute primary central or peripheral neuromuscular disorder.
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- Presence of a chronic tracheostomy (present prior to ICU admission).
- Pre-existing head and neck cancer or surgery.
- Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
- Delirium as assessed by CAM-ICU
- Inability to obtain informed consent from patient or an appropriate surrogate.
- Age <18 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Anna Matheson, BSN, 484-883-6222, anna.matheson@cuanschutz.edu
Jeffrey McKeehan, MSN, 3037246080, jeffrey.mckeehan@cuanschutz.edu
About this study
Official title: Randomized Trial of Corticosteroids for Post-Extubation Aspiration
This is a placebo-controlled, double-blind randomized trial of a short course of intravenous corticosteroids for Acute Respiratory Failure Survivors with Fiberoptic Endoscopic Evaluation of Swallowing (FEES) documented laryngeal edema. Study was leveraged using the existing R01 grant infrastructure COMIRB # 21-3873, study design, and research methods. Patients for the study proposed will have already been enrolled in the R01 longitudinal cohort study. The sites to perform this study include Colorado, BU, Yale, Tufts, and Stanford. Those R01-enrolled patients with laryngeal edema on their initial FEES examination: defined as the revised Patterson edema score greater than zero, will be approached for enrollment.
Read the detailed description
This is a multicenter study conducted across the University of Colorado, Boston University, Stanford University, Tufts Medical Center, and Yale University. The study aims to enroll a total of 80 participants, with approximately 20 participants at each site. This study aims to investigate the effects of intravenous corticosteroids on laryngeal edema and swallowing function in survivors of acute respiratory failure (ARF) who have documented laryngeal edema. It evaluates whether administering corticosteroids can reduce edema and improve quality of life related to swallowing after hospital discharge. The study includes ARF survivors with confirmed laryngeal edema, who will be randomized into two groups. Patients in the intervention group will receive 50 mg of methylprednisolone intravenously every six hours for a total of four doses, amounting to 200 mg (equivalent to 1,000 mg of hydrocortisone), while the control group will receive a saline placebo intravenously under the same regimen.
The primary outcomes of the study focus on measuring the reduction in laryngeal edema post-treatment and evaluating post-extubation swallowing function. Secondary outcomes include assessing quality of life one month after hospitalization, particularly regarding swallowing function and the ability to return to pre-hospitalization dietary habits. To measure laryngeal edema, the Revised Patterson Edema Scale will be utilized, which assesses edema across eight specific regions of the upper airway (such as the epiglottis and vallecula). Each area is rated on a scale from 0 to 3, resulting in an overall score ranging from 0 (normal) to 24 (severe edema). This scale has been adapted for the study to enhance sensitivity and reliability, showing moderate to good interrater reliability across assessed areas.
Participants will be randomized in a 1:1 ratio using a permuted block randomization method to ensure balanced allocation. The findings from this study could have significant implications for post-extubation care in ARF survivors, potentially guiding clinical practices for managing laryngeal edema and improving patients' swallowing function and overall quality of life after hospitalization.
- Conditions
- Dysphagia, Laryngeal Edema
- Being tested
- Methylprednisolone, Normal Saline
- Medical subject headings
- Deglutition Disorders, Laryngeal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg methylprednisolone IV every 6 hours for 4 doses to reduce laryngeal edema
Normal SalineDrug
Normal Saline placebo IV every 6 hours for 4 doses
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Intervention | Experimental | 50 mg Methylprednisolone IV every 6 hours for 4 doses (total dose 200mg) Receives: Drug: Methylprednisolone |
| Placebo Control | Placebo comparator | Normal Saline placebo dose IV every 6 hours for 4 doses Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre/post intervention change in the revised Patterson edema scale on FEES exam
Investigators hypothesize that corticosteroids will be more effective (a larger pre/post reduction in the revised Patterson Edema scale) for resolution of swallowing dysfunction in patients recovering from acute respiratory failure with the presence of laryngeal edema on a FEES examination. Change is defined as the pre-study total FEES revised Patterson Edema scale minus the post-study total FEES revised Patterson Edema scale. Improvement in the total revised Patterson Edema scale would a positive number. For example, the pre-study total score was 15, the post-study total score was 8; therefore, the change would be a score of 7. Improvement in the total revised Patterson Edema scale would a positive number
Measured: Day 1 through Day 5
Secondary outcomes (2)
Change in Individual Components of the Revised Patterson Edema Scale
Since there is variability in the amount of edema in the eight different locations of the revised Patterson edema scale, investigators will examine the effect of corticosteroids compared to placebo on the change in edema in each of these eight areas. Change is defined as the pre-study FEES revised Patterson Edema scale minus the post-study FEES revised Patterson Edema scale. The scale assesses eight areas of the upper airway (epiglottis, vallecula, pharyngoepiglottic folds, aryepiglottic folds, arytenoids, false vocal cords, true vocal cords, and pyriform sinuses) using a normal, mild, moderate, or severe scale. For this proposal, we have adapted this rating system to a 0-3 scale (normal =0 and severe = 3) for each of the eight locations in the upper airway. The overall score can range from 0 (normal) to 24 (severe edema in all 8 areas). The overall interrater reliability of the revised Patterson scale maintains moderate-good agreement for each of the eight upper airway locations.
Measured: Day 1 through Day 5
Change in the Penetration-Aspiration Scale (PAS) Score
Investigators will determine whether the administration of corticosteroids results in improvement in the severity of dysphagia and aspiration. The PAS score is a validated measure of the degree of aspiration on FEES of the visualized swallowed bolus. A PAS score of 2-5 defined penetration of the bolus into the laryngeal area above the vocal cords but without entering the airway. A PAS score of 6 or greater defines as aspiration. A PAS score of 6-7 represents non-silent aspiration, and a score of 8 represents silent aspiration. Investigators will determine a PAS score for each bolus during the two FEES examinations.
Measured: Day 1 through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start2 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter prospective randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Marc Moss, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670521
- Sponsor's protocol ID
- 24-1535
- Other IDs
- R21AG089278
- Acronym
- COPED
- Status last verified
- May 2026
- First submitted
- 19 Sep 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Corticosteroids for Post-Extubation Aspiration
- ClinicalTrials.gov ID
- NCT06670521
- Acronym / sponsor ID
- COPED / 24-1535
- Conditions
- Dysphagia, Laryngeal Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a placebo-controlled, double-blind randomized trial of a short course of intravenous corticosteroids for Acute Respiratory Failure Survivors with Fiberoptic Endoscopic Evaluation of Swallowing (FEES) documented laryngeal edema. Study was leveraged using the existing R01 grant infrastructure COMIRB # 21-3873, study design, and research methods. Patients for the study proposed will have already been enrolled in the R01 longitudinal cohort study. The sites to perform this study include Colorado, BU, Yale, Tufts, and Stanford. Those R01-enrolled patients with laryngeal edema on their initial FEES examination: defined as the revised Patterson edema score greater than zero, will be approached for enrollment.
Detailed description
This is a multicenter study conducted across the University of Colorado, Boston University, Stanford University, Tufts Medical Center, and Yale University. The study aims to enroll a total of 80 participants, with approximately 20 participants at each site. This study aims to investigate the effects of intravenous corticosteroids on laryngeal edema and swallowing function in survivors of acute respiratory failure (ARF) who have documented laryngeal edema. It evaluates whether administering corticosteroids can reduce edema and improve quality of life related to swallowing after hospital discharge. The study includes ARF survivors with confirmed laryngeal edema, who will be randomized into two groups. Patients in the intervention group will receive 50 mg of methylprednisolone intravenously every six hours for a total of four doses, amounting to 200 mg (equivalent to 1,000 mg of hydrocortisone), while the control group will receive a saline placebo intravenously under the same regimen.
The primary outcomes of the study focus on measuring the reduction in laryngeal edema post-treatment and evaluating post-extubation swallowing function. Secondary outcomes include assessing quality of life one month after hospitalization, particularly regarding swallowing function and the ability to return to pre-hospitalization dietary habits. To measure laryngeal edema, the Revised Patterson Edema Scale will be utilized, which assesses edema across eight specific regions of the upper airway (such as the epiglottis and vallecula). Each area is rated on a scale from 0 to 3, resulting in an overall score ranging from 0 (normal) to 24 (severe edema). This scale has been adapted for the study to enhance sensitivity and reliability, showing moderate to good interrater reliability across assessed areas.
Participants will be randomized in a 1:1 ratio using a permuted block randomization method to ensure balanced allocation. The findings from this study could have significant implications for post-extubation care in ARF survivors, potentially guiding clinical practices for managing laryngeal edema and improving patients' swallowing function and overall quality of life after hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter prospective randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Intervention | Experimental | Drug: Methylprednisolone50 mg Methylprednisolone IV every 6 hours for 4 doses (total dose 200mg) |
| Placebo Control | Placebo comparator | Drug: Normal SalineNormal Saline placebo dose IV every 6 hours for 4 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant enrolled in primary study COMIRB #21-3873/ NCT # 05108896
- Laryngeal edema identified on participants primary study Fiberoptic Endoscopic Evaluation of Swallowing (FEES) as defined as a revised Patterson edema score greater than zero
- Admission to an ICU during their hospitalization
- Mechanical ventilation with an endotracheal tube for greater than 48 hours.
- Extubation except for compassionate extubation or transition to end-of-life care.
Key exclusion criteria (12 listed)
- Patient or provider refusal
- Contraindication or corticosteroids defined as an allergic reaction (extremely rate) or taking other immunosuppressive medications.
- Chronic treatment with corticosteroids (>= 40 mg Prednisone/day, >=32 Methylprednisolone/day)
- Contraindication to enteral/oral nutrition administration.
- Pre-existing history of dysphagia or aspiration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone50 mg methylprednisolone IV every 6 hours for 4 doses to reduce laryngeal edema | Drug | Corticosteroid Intervention |
| Normal SalineNormal Saline placebo IV every 6 hours for 4 doses | Drug | Placebo Control |
Primary outcome
Pre/post intervention change in the revised Patterson edema scale on FEES exam
Time frame: Day 1 through Day 5
Investigators hypothesize that corticosteroids will be more effective (a larger pre/post reduction in the revised Patterson Edema scale) for resolution of swallowing dysfunction in patients recovering from acute respiratory failure with the presence of laryngeal edema on a FEES examination. Change is defined as the pre-study total FEES revised Patterson Edema scale minus the post-study total FEES revised Patterson Edema scale. Improvement in the total revised Patterson Edema scale would a positive number. For example, the pre-study total score was 15, the post-study total score was 8; therefore, the change would be a score of 7. Improvement in the total revised Patterson Edema scale would a positive number
2 secondary outcomes
Change in Individual Components of the Revised Patterson Edema Scale
Time frame: Day 1 through Day 5
Change in the Penetration-Aspiration Scale (PAS) Score
Time frame: Day 1 through Day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Moss, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylprednisolone and Normal Saline in people with Dysphagia and Laryngeal Edema, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Matheson, BSN (4848836222, anna.matheson@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre/post intervention change in the revised Patterson edema scale on FEES exam (time frame: Day 1 through Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.