Inhaled Ciclesonide for Bronchopulmonary Dysplasia

Overseen By Miah R Ruffin, BA, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new inhaled medication, ciclesonide, to determine its safety for treating lung problems in very premature infants. The researchers aim to understand the drug's absorption and effects on the body. Two groups participate: one receives the treatment, and the other follows standard care. Infants who might be suitable are those born very early (between 23 and 29 weeks) and currently requiring a breathing tube. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new medication.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that inhaled ciclesonide is likely to be safe for humans?

Research has shown that inhaled ciclesonide might be safe for premature babies. Studies have found that it is well-tolerated and primarily remains in the lungs, reducing the risk of side effects elsewhere in the body. In newborn studies, ciclesonide has been linked to improved lung function. Although these results are encouraging, researchers continue to investigate the long-term effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about inhaled Ciclesonide for bronchopulmonary dysplasia because it introduces a new method of delivering treatment directly to the lungs. Unlike current treatments that often involve systemic administration, Ciclesonide is inhaled, which means it can target the lungs more directly and potentially with fewer side effects. Additionally, its active ingredient, Ciclesonide, is a corticosteroid that may reduce inflammation in the lungs more effectively than existing options. This delivery method and targeted action could lead to quicker and more efficient relief for infants with this condition.

What evidence suggests that inhaled ciclesonide might be an effective treatment for bronchopulmonary dysplasia?

Research has shown that ciclesonide, an inhaled medication, may protect the lungs of newborn rats. This treatment improved their lung function and overall lung health. Studies suggest it could serve as a good alternative to other steroids for treating bronchopulmonary dysplasia (BPD) in newborns. In animals, ciclesonide helped the lungs expand and contract more easily. In this trial, some infants will receive inhaled ciclesonide to explore its potential benefits for lung health. There is hope for similar benefits in infants, but more research is needed to confirm this in humans. ^{2 3 4 5 6}

Who Is on the Research Team?

Venkatesh Sampath, MD

Principal Investigator

Physician-Scientist

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11472001/

Ciclesonide exhibits lung-protective effects in neonatal rats ... Postnatal administration of ciclesonide for 5 days was associated with significantly better outcomes in terms of lung compliance, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06589245

NCT06589245 | Inhaled Ciclesonide Study in Preterm Infants Clinical trials have shown that hydrocortisone targeted to infants with emerging lung disease does not prevent BPD, while inhaled sGC therapy has shown mixed ...

3. clinicaltrial.be clinicaltrial.be/en/details/451489?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Inhaled Ciclesonide Study in Preterm Infants This study tests the hypothesis that CIC will have minimal systemic absorption and a favorable safety profile in premature infants at risk of developing BPD.

4. e-cep.org e-cep.org/upload/pdf/cep-2025-01137.pdf

Accepted Article These findings suggest that postnatal ciclesonide may be an alternative to existing corticosteroids for the treatment of BPD. However, longterm studies are ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41035248/

Ciclesonide shows a lung-protective effect in neonatal ... Ciclesonide administration was associated with smaller body weight changes and significantly improved lung compliance, alveolarization, lung ...

6. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11161516

Inhaled ciclesonide - a phase I study in preterm infants We hypothesize that CIC will have minimal systemic absorption and a favorable safety profile in premature infants at risk of developing BPD. In Aim 1, we will ...