Inhaled Ciclesonide for Bronchopulmonary Dysplasia

Overseen By Anne M Holmes, RN, MSN,CCRC

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Congenital anomalies, Life-threatening illness, Sepsis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Our overall objective is to conduct a safety study with inhaled ciclesonide to evaluate known glucocorticoids (sGC)-related acute and intermediate toxic effects while measuring for the first time in neonates its systemic absorption and potential bioactivity (i.e. activation of primary target, the GR, in blood cells).

Research Team

Venkatesh Sampath, MD

Principal Investigator

Physician-Scientist

Eligibility Criteria

This trial is for preterm infants born between 23 to just under 30 weeks of gestation, who are between 8 and 28 days old and need breathing support through a tube. It's not suitable for those outside this age or gestational range.

Inclusion Criteria

I need a breathing machine through a tube in my windpipe.

My baby was born between 23 and 29 weeks of pregnancy.

My newborn is between 8 to 28 days old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Inhaled Alvesco is administered daily for 14 days at escalating doses of 80mcg and 160mcg

2 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood glucose and blood pressure monitoring

4 months

Long-term follow-up

Monitoring of BPD and severe BPD rates at 36 weeks post-menstrual age

Until 36 weeks post-menstrual age

Treatment Details

Interventions

• Ciclesonide

Trial Overview The study tests the safety of an inhaled medication called Ciclesonide (Alvesco) on premature babies with lung problems. It checks for side effects related to steroid use, measures how much gets into the bloodstream, and its activity in blood cells.

Participant Groups

Group I: Ciclesonide Experimental Treatment 1 Intervention

Eligible infants will be approached by study team. Parents whose infants consent to the study drug will enter the dose-escalation part of the study. Inhaled Alvesco will be administered daily for 14 days at escalating doses 80mcg and 160mcg.

Group II: Control Active Control 1 Intervention

Eligible infants will be approached by study team. Parents who refuse consent to the study drug will have standard of care. These parents can accept for their infant's de-identified clinical data to be used as part of the control group.

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+