Corticosteroids for Swallowing Difficulty
(COPED Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Colorado, Denver
Must not be taking: Immunosuppressives, Corticosteroids
Disqualifiers: Dysphagia, Neuromuscular disorder, Tracheostomy, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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, 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on chronic corticosteroid treatment, you cannot participate.
What data supports the effectiveness of the drug Methylprednisolone for swallowing difficulty?
Methylprednisolone has shown effectiveness in improving clinical conditions in patients with brain tumors and reducing inflammation in multiple sclerosis, suggesting its potential to help with conditions involving inflammation, which might be relevant for swallowing difficulties.
12345Is methylprednisolone generally safe for humans?
Methylprednisolone, used under various names like Depo-Medrol and Medrol, has been associated with some safety concerns. There have been reports of serious side effects such as retinal toxicity and visual loss when injected improperly, and it has been linked to a condition called arachnoiditis in some cases.
34678How is the drug Methylprednisolone unique for treating swallowing difficulty?
Methylprednisolone is a corticosteroid that reduces inflammation, which might help with swallowing difficulties by decreasing swelling in the throat. Its use in this context is unique because there are no standard treatments specifically for swallowing difficulties, making it a novel approach.
13689Eligibility Criteria
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.Inclusion Criteria
I have been extubated for reasons other than end-of-life care.
Participant enrolled in primary study COMIRB #21-3873/ NCT #05108896
I was admitted to the ICU during my hospital stay.
+2 more
Exclusion Criteria
I have a bleeding disorder causing uncontrolled nose or throat bleeding.
I have a history of swallowing difficulties or inhaling food/liquid into my lungs.
I cannot receive nutrition by mouth or feeding tube.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either 50 mg of methylprednisolone intravenously every six hours for four doses or a saline placebo under the same regimen
5 days
Daily visits for 5 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of laryngeal edema and swallowing function
1 month
Telephone follow-up
Post-Discharge Assessment
Participants complete various assessments to evaluate quality of life, caregiver assistance, and social support one month after hospital discharge
1 month post-discharge
Participant Groups
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.
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
Methylprednisolone is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Medrol for:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
🇪🇺 Approved in European Union as Depo-Medrol for:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
🇨🇦 Approved in Canada as Solu-Medrol for:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ColoradoAurora, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Methylprednisolone treatment in patients with brain tumors. [2019]A study was made in 10 patients with brain tumors of the effect of methylprednisolone sodium succinate (Solu-Medrol) on clinical neurological status, intracranial pressure, and periventricular elastance. Significant clinical improvement and reduction in periventricular elastance both ocurred within 24 hours of starting treatment, whereas intracranaial pressure was not significantly reduced until the 2nd day of therapy.
Absolute bioavailability of a new high dose methylprednisolone tablet formulation. [2013]This was a single-blind, single-dose, randomized crossover study to determine the absolute bioavailability of Medrol, a new high dose (100 mg) methylprednisolone tablet product, by comparing it with 100 mg methylprednisolone from an intravenous formulation, Solu-Medrol. Fourteen healthy, non-smoking, Caucasian male volunteers took part. On treatment days volunteers remained recumbent for 4 hours after drug administration, with food and fluid intake standardized over this period. Serial blood samples were drawn over a 14-hour period after drug administration. Plasma methylprednisolone concentrations were determined by high performance liquid chromatography. The geometric means of AUCi.v. and AUCtablet were 4,049 and 3,334 ng.h/ml, respectively. The absolute bioavailability of the tablet product was 82%, which is in agreement with published data for other oral dosage forms of methylprednisolone. Volunteers displayed the expected rise in peripheral blood neutrophil count, but no other clinically relevant changes in hematology or clinical chemistry were observed. No adverse drug reactions were recorded. It is concluded that the tablet product can be used as a substitute for parenteral methylprednisolone in situations requiring high-dose therapy.
Depo-Medrol and myelographic arachnoiditis. [2021]This study was undertaken to see if patients who had a radiological diagnosis of arachnoiditis attributed to methylprednisolone acetate (Depo-Medrol, Upjohn Pty Limited) had the clinical syndrome of arachnoiditis.
Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital. [2022]To manage relapsing-remitting multiple sclerosis (MS) in the course of acute exacerbations, methylprednisolone (MP) (Medrol or Solu-Medrol), has the ability to lock the injured blood-brain barrier and decrease irritation in the central nervous system. The aim of this preliminary study was to investigate the frequency and time interval related to MP pulse therapy in patients with MS.
Survey of orthopaedic and sports medicine physicians regarding use of medrol dosepak for sports injuries. [2018]To study the use of a methylprednisolone taper (Medrol Dosepak; Pfizer, New York, NY) short-term oral corticosteroid treatment modality by sports medicine physicians; included is discussion on indications, perceived efficacy, and complications.
Retinal and choroidal microvascular embolism after intranasal corticosteroid injection. [2022]Two patients had uniocular visual loss after methylprednisolone acetate (Depo-Medrol) injection for control of chronic inflammatory conditions in the nose. The cause of the visual loss was embolic retinal and choroidal vascular occlusion. The emboli were presumably aggregates of microcrystals of methylprednisolone acetate.
Pharmacokinetics and bioequivalence of two methylprednisolone tablet formulations in healthy Chinese subjects under fasting and fed conditions. [2023]The aims of this study were to evaluate and compare the pharmacokinetic profiles and bioequivalence of two tablet formulations of methylprednisolone (test formulation: Zhejiang Xianju Pharmaceutical Co., Ltd., China; reference formulation: Medrol, Pfizer Italia SRL) in healthy Chinese subjects under fasting and fed conditions.
Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]Methylprednisolone acetate (Depo-Medrol, Pfizer, New York) is a depot corticosteroid that is commonly injected periorbitally to treat various ophthalmologic conditions. Accidental intravitreal injections secondary to globe perforations have resulted in rapid retinal toxicity. To their knowledge, the authors report the first case of inadvertent intravitreal methylprednisolone acetate injection during pars plana vitrectomy.
Management of diskogenic pain using epidural and intrathecal steroids. [2019]The use of methylprednisolone acetate (Depo-Medrol) injected by the epidural or intrathecal route for the relief of diskogenic back pain with or without radiculopathy is an adjunct to conservative management useful when conservative measures fail and surgical treatment is under consideration. This is especially true when symptoms have been present for only a few months. Corticosteroids injected in the same manner seem to have little effect on patients with symptoms persisting for periods longer than 3 months or in patients treated previously by surgical methods.