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Corticosteroid

Budesonide for Engraftment Syndrome After Stem Cell Transplant

Phase 3
Recruiting
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post stem cell transplant
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if a drug can reduce fever after stem cell transplants, to help patients recover better.

Who is the study for?
This trial is for adults aged 18-80 who are set to undergo stem cell transplantation for blood cancers. It's not open to those getting transplants for non-blood cancers or anyone already in another clinical study.
What is being tested?
The trial is testing if budesonide, started on day 5 after a transplant, can prevent engraftment fever in patients receiving their own (autologous) or donor (allogeneic) stem cells.
What are the potential side effects?
Budesonide may cause side effects like irritation of the stomach lining, increased risk of infection, high blood sugar levels, and mood swings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post stem cell transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post stem cell transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
non-infectious fever

Side effects data

From 2016 Phase 4 trial • 222 Patients • NCT02055352
9%
Influenza
9%
Nasopharyngitis
8%
Headache
7%
Dysphonia
6%
Urinary tract infection
6%
Arthralgia
5%
Back pain
2%
Chronic obstructive pulmonary disease
1%
Vascular insufficiency
1%
Venous thrombosis limb
1%
Peripheral arterial occlusive disease
1%
Acute myocardial infarction
1%
Cor pulmonale
1%
Nodal arrhythmia
1%
Pneumonia
1%
Hip fracture
1%
Hepatocellular carcinoma
1%
Acute pulmonary oedema
1%
Bradycardia
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluticasone / Salmeterol (B)
Budesonide / Indacaterol (A)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BudesonideExperimental Treatment1 Intervention
Group II: nothingActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
2017
Completed Phase 4
~13050

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,256 Total Patients Enrolled

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05509933 — Phase 3
Transplant reaction Research Study Groups: nothing, Budesonide
Transplant reaction Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT05509933 — Phase 3
Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05509933 — Phase 3
~8 spots leftby Jan 2025
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