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Mineralocorticoid Receptor Antagonist

Spironolactone for Lung Disease

Phase 2 & 3
Waitlist Available
Led By Courtney B Sweet, PharmD
Research Sponsored by West Virginia University Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights

Study Summary

Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major complication of premature birth and is associated with a significant increased risk of complications including death. Diuretics have been used for decades in babies with BPD and are considered a standard of care. Patients receive electrolyte supplementation to replace the electrolytes removed by the diuretics. Spironolactone is not as good as other diuretics at removing extra fluid, but it is different from chlorothiazide and furosemide because instead of removing potassium, it actually can increase potassium levels in our body. Spironolactone is used with chlorothiazide to try to minimize the potassium lost; therefore, reduce the electrolyte supplementation needed. However, studies have suggested that preterm babies aren´t developed enough to appropriately respond to spironolactone. Also, one study has shown that adding spironolactone to chlorothiazide in patients with BPD has no effect on whether or not patients receive electrolyte supplementation. This study will examine whether there is a difference in the amount of electrolyte supplementation between patients receiving chlorothiazide only or chlorothiazide plus spironolactone. the investigators hypothesize there will be no difference in the amount of electrolyte supplementation between the two groups.

Eligible Conditions
  • Lung Disease
  • Bronchopulmonary Dysplasia

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose of potassium chloride in milliequivalents/kg/day
Secondary outcome measures
Analyze the use of furosemide rescue doses
Escalation in respiratory support
Number of furosemide doses utilized
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SpironolactoneActive Control1 Intervention
Oral spironolactone suspension dosed at 3 mg/kg/day will be administered once-daily to the patients assigned to the treatment arm.
Group II: Placebo suspensionPlacebo Group1 Intervention
An oral placebo suspension dosed at 3 mg/kg/day administered once-daily will be given to patients in the placebo arm.

Find a Location

Who is running the clinical trial?

West Virginia University HealthcareLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Courtney B Sweet, PharmDPrincipal InvestigatorWVU Healthcare

Frequently Asked Questions

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Recent research and studies
~3 spots leftby May 2025