Bronchopulmonary DysplasiaPhase 1NCT06589245
Inhaled Ciclesonide Study in Preterm Infants
A Phase 1 study testing Alvesco Inhalant Product in people with Bronchopulmonary Dysplasia, run by Venkatesh Sampath at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 8 to 35 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Alvesco Inhalant Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 35 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Viable Infants born between 23 0/7 - 29 6/7 gestation
- Requiring invasive (through an endotracheal tube) mechanical ventilation
- Between day of life 8 to 35.
- Infants have not received dexamethasone for 120 hours
- If receiving hydrocortisone, then receiving ≤ 1mg/kg/day
Who cannot join
- Infants with major congenital lung or other organ anomalies, life-threatening illness, active sepsis or NEC, and grade IV hemorrhage will be excluded.
- Infants receiving DEX therapy will be excluded.
- We will exclude infants who have had ≥ 1 glucose level > 150mg in the 24 hours prior to study entry or those on insulin therapy to treat hyperglycemia. We will exclude infants who have hypertension (>95% centile for gestational age) in the 48 hours prior to study entry.
- For small for gestational age, we will exclude infants with a birthweight < 5% centile for gestational age.
- Infants with history of recent pulmonary hemorrhage (within 72 hours of study entry) will also be excluded.
- Infants receiving or have received any dexamethasone in the prior 120 hours.
- Infants receiving >1mg/kg/day of hydrocortisone.
- Infants receiving any other inhaled or systemic steroid.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Venkatesh Sampath, MD, 816-802-1177 ext. 78167, vsampath@cmh.edu
Mariana Theodoro, MD, 816-234-3591, mftheodoro@cmh.edu
About this study
Official title: The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia
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).
Read the detailed description
Preterm infants born before 30 weeks gestation are at increased risk of developing bronchopulmonary dysplasia (BPD), a leading cause of death and long-term pulmonary insufficiency. Both hydrocortisone and synthetic glucocorticoids (sGC) are commonly used to prevent BPD in premature 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 efficacy in clinical trials. Dexamethasone (DEX) has been shown in clinical trials to reduce BPD rates in premature infants but is associated with short term and long-term adverse effects including cerebral palsy. There is an unmet need for efficacious Glucocorticoid (GC) therapy in premature infants to prevent BPD without encumbering serious adverse events. To address this challenge, our group has been investigating ciclesonide (CIC), a sGC pro-drug that in the inhaled form is FDA approved for use in asthma and allergic rhinitis in older children. Our published and ongoing work has shown that DEX and CIC regulate GR transcriptional targets and several genes implicated in lung protective effects in neonatal rats. Remarkably, CIC does not suppress somatic growth nor IGF-1 levels, induce hyperglycemia, or cause neuroanatomical changes in the cerebral cortex of neonatal rats, which are known pathologies caused by DEX in premature infants. Furthermore, ongoing studies reveal that CIC is as efficacious as DEX in preventing lung injury in a hyperoxia-model of experimental BPD. 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.
The fear of long-term neurological adverse effects has limited optimal use of sGC therapy to prevent BPD. This application is significant as it proposes to repurpose CIC, an existing sGC, for novel therapeutic use in preterm infants to prevent BPD. CIC is already FDA-approved for use in children >5 years for allergic rhinitis and asthma, and can be used on a compassionate basis down to 2 years of age. The investigators believe our study is impactful and translationally relevant as it addresses an unmet need for efficacious GC therapy to prevent BPD in premature infants without encumbering the neurological and somatic adverse effects. Successful testing of our hypothesis will pave the way for a large, multicenter randomized control trial of CIC therapy in premature infants to prevent BPD.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Alvesco Inhalant Product
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alvesco Inhalant ProductDrug
Also called ciclesonide
Inhaled Alvesco will be administered daily for 14 days at escalating doses of 80mcg and 160mcg.
| Study group | Role | What they receive |
|---|---|---|
| Ciclesonide | Experimental | 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. Receives: Drug: Alvesco Inhalant Product |
| Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hyperglycemia events (blood glucose >150mg/dL) during treatment.
Blood Glucose (BG) levels will be collected 24 hours prior to initiation of study drug and then every 12 hours after initiation of study drug for 2 weeks. BG will be monitored daily for a week after cessation of drug treatment and as per NICU protocol thereafter.
Measured: Through study completion, an average of 4 months.
Average change in z-scores for weight, length, and head circumference.
Baseline weight, head circumference, and length measurements will be measured as per routine NICU standards, which is daily weights and weekly length and head circumference. Weights, lengths and weights/lengths are routinely plotted in the growth chart for each baby in the NICU, and z-scores trajectories deviations (positive or negative) derived against published reference standards for this population. We will compare the average z-score deviations for growth parameters among infants exposed to the study drug and controls unexposed to study drug.
Measured: Through the time of discharge, an average of 4 months.
Number of high systolic blood pressure events defined as >95% centile for gestational age and day of life.
Blood Pressure will be collected 48 hours prior to initiation of study drug as per NICU protocol (at least twice a day) and then every 8 hours after initiation of study drug for 2 weeks. Blood pressure will also be monitored at least daily for first two weeks after cessation of drug treatment, and as per NICU protocol till discharge (at least once a day). Blood pressure is usually monitored using appropriate BP cuff size for weights. If indwelling arterial catheters are present, then blood pressures will be measured that way.
Measured: Through the time of discharge, an average of 4 months.
Number of infants who do not pass the Adrenocorticotrophic Hormone (ACTH) stimulation test.
Measured via Adrenocorticotropic Hormone (ACTH) Stimulation Test, which quantifies the increase in cortisol after ACTH administration.
Measured: 6 weeks or later after last postnatal steroid course, prior to discharge
Number of episodes of bronchospasm related to inhaled ciclesonide administration.
The investigators will quantify any episodes of bronchospasm as evaluated by changes in oxygenation/ventilation status, auscultation for wheezes and changes in ventilator loops. This is evaluated by experienced respiratory therapists and bedside nurses.
Measured: The entire duration of the study drug treatment (14 days).
Number of infants who develop oral thrush that require treatment.
Bedside nurses routinely evaluate for this common, mostly benign complication of prematurity. We will collect data on % of infants who develop oral thrush and % of infants that require topical treatment among infants exposed to inhaled ciclesonide and the control group.
Measured: The duration of study drug treatment (14 days).
Compare rates of BPD and severe BPD between cases and controls.
Investigators will collect and report data on BPD and severity on each infant in the study irrespective of whether they were treated with inhaled ciclesonide or served as a control. We will also compare rates of BPD and severe BPD among the two groups.
Measured: BPD and severe BPD are ascertained at 36 weeks post-menstrual age.
Systemic Absorption of inhaled Ciclesonide
Investigators will measure serum levels of ciclesonide and its active metabolite, des-ciclesonide 3 hour after inhaled drug administration (based on T1/2 in prior studies in children) in peripheral blood by mass spectrometry. This will provide us information on CIC to des-CIC conversion in preterm neonates, as well correlation with doses administered. Measured in picomol/ml (pmol/mL).
Measured: Day 1, 3, 7, 15 of study (during drug administration).
Secondary outcomes (2)
Compare rates of extubation success between infants exposed to study drug and controls receiving standard NICU clinical care
Investigators will compare the rates of extubation (weaning from invasive endotracheal tube-delivered mechanical ventilation to nasal respiratory support) between infants receiving study drug and controls not receiving study drug. Successful extubation will be considered as staying extubated for 72 hours.
Measured: Extubation rates will be calculated from the day of study drug initiation to 7 days after cessation of study drug, i.e., a 21 day window.
Assess changes in lung injury and need in mechanical ventilation support.
Lung injury is difficult to characterize in preterm neonates. The pulmonary severity score that combines level and type of support (high frequency oscillator vs. conventional ventilator), oxygen requirements and respiratory drug therapy to calculate a score is accepted as a measure of lung injury and lung disease severity in this population. We will measure pulmonary severity scores to assess lung injury and lung disease severity. Temporal trends will assess whether PSS decreased after initiation of CIC therapy. Higher score indicate a worse outcome. PSS scores range between 0.21 to 2.95
Measured: Baseline, and daily from study drug initiation to 1 week after study drug cessation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Sep 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An open label dose escalation
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venkatesh Sampath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Venkatesh Sampath, Children's Mercy Hospital Kansas City
- Investigators
- Venkatesh Sampath, MD, Principal investigator, Children's Mercy Hospital Kansas CityVenkatesh Sampath, MD, Principal investigator, Physician-Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589245
- Sponsor's protocol ID
- STUDY00003195
- Other IDs
- R21HD116421
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT06589245
- Acronym / sponsor ID
- STUDY00003195
- Conditions
- Bronchopulmonary Dysplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Venkatesh SampathUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Preterm infants born before 30 weeks gestation are at increased risk of developing bronchopulmonary dysplasia (BPD), a leading cause of death and long-term pulmonary insufficiency. Both hydrocortisone and synthetic glucocorticoids (sGC) are commonly used to prevent BPD in premature 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 efficacy in clinical trials. Dexamethasone (DEX) has been shown in clinical trials to reduce BPD rates in premature infants but is associated with short term and long-term adverse effects including cerebral palsy. There is an unmet need for efficacious Glucocorticoid (GC) therapy in premature infants to prevent BPD without encumbering serious adverse events. To address this challenge, our group has been investigating ciclesonide (CIC), a sGC pro-drug that in the inhaled form is FDA approved for use in asthma and allergic rhinitis in older children. Our published and ongoing work has shown that DEX and CIC regulate GR transcriptional targets and several genes implicated in lung protective effects in neonatal rats. Remarkably, CIC does not suppress somatic growth nor IGF-1 levels, induce hyperglycemia, or cause neuroanatomical changes in the cerebral cortex of neonatal rats, which are known pathologies caused by DEX in premature infants. Furthermore, ongoing studies reveal that CIC is as efficacious as DEX in preventing lung injury in a hyperoxia-model of experimental BPD. 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.
The fear of long-term neurological adverse effects has limited optimal use of sGC therapy to prevent BPD. This application is significant as it proposes to repurpose CIC, an existing sGC, for novel therapeutic use in preterm infants to prevent BPD. CIC is already FDA-approved for use in children >5 years for allergic rhinitis and asthma, and can be used on a compassionate basis down to 2 years of age. The investigators believe our study is impactful and translationally relevant as it addresses an unmet need for efficacious GC therapy to prevent BPD in premature infants without encumbering the neurological and somatic adverse effects. Successful testing of our hypothesis will pave the way for a large, multicenter randomized control trial of CIC therapy in premature infants to prevent BPD.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open label dose escalation
| Arm | Type | Receives |
|---|---|---|
| Ciclesonide | Experimental | Drug: Alvesco Inhalant ProductEligible 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. |
| Control | No 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 may qualify
- Ages
- 8 to 35 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Viable Infants born between 23 0/7 - 29 6/7 gestation
- Requiring invasive (through an endotracheal tube) mechanical ventilation
- Between day of life 8 to 35.
- Infants have not received dexamethasone for 120 hours
- If receiving hydrocortisone, then receiving ≤ 1mg/kg/day
Key exclusion criteria (8 listed)
- Infants with major congenital lung or other organ anomalies, life-threatening illness, active sepsis or NEC, and grade IV hemorrhage will be excluded.
- Infants receiving DEX therapy will be excluded.
- We will exclude infants who have had ≥ 1 glucose level > 150mg in the 24 hours prior to study entry or those on insulin therapy to treat hyperglycemia. We will exclude infants who have hypertension (>95% centile for gestational age) in the 48 hours prior to study entry.
- For small for gestational age, we will exclude infants with a birthweight < 5% centile for gestational age.
- Infants with history of recent pulmonary hemorrhage (within 72 hours of study entry) will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alvesco Inhalant ProductAlso: ciclesonideInhaled Alvesco will be administered daily for 14 days at escalating doses of 80mcg and 160mcg. | Drug | Ciclesonide |
Primary outcome
Number of hyperglycemia events (blood glucose >150mg/dL) during treatment.
Time frame: Through study completion, an average of 4 months.
Blood Glucose (BG) levels will be collected 24 hours prior to initiation of study drug and then every 12 hours after initiation of study drug for 2 weeks. BG will be monitored daily for a week after cessation of drug treatment and as per NICU protocol thereafter.
Average change in z-scores for weight, length, and head circumference.
Time frame: Through the time of discharge, an average of 4 months.
Baseline weight, head circumference, and length measurements will be measured as per routine NICU standards, which is daily weights and weekly length and head circumference. Weights, lengths and weights/lengths are routinely plotted in the growth chart for each baby in the NICU, and z-scores trajectories deviations (positive or negative) derived against published reference standards for this population. We will compare the average z-score deviations for growth parameters among infants exposed to the study drug and controls unexposed to study drug.
Number of high systolic blood pressure events defined as >95% centile for gestational age and day of life.
Time frame: Through the time of discharge, an average of 4 months.
Blood Pressure will be collected 48 hours prior to initiation of study drug as per NICU protocol (at least twice a day) and then every 8 hours after initiation of study drug for 2 weeks. Blood pressure will also be monitored at least daily for first two weeks after cessation of drug treatment, and as per NICU protocol till discharge (at least once a day). Blood pressure is usually monitored using appropriate BP cuff size for weights. If indwelling arterial catheters are present, then blood pressures will be measured that way.
Number of infants who do not pass the Adrenocorticotrophic Hormone (ACTH) stimulation test.
Time frame: 6 weeks or later after last postnatal steroid course, prior to discharge
Measured via Adrenocorticotropic Hormone (ACTH) Stimulation Test, which quantifies the increase in cortisol after ACTH administration.
Number of episodes of bronchospasm related to inhaled ciclesonide administration.
Time frame: The entire duration of the study drug treatment (14 days).
The investigators will quantify any episodes of bronchospasm as evaluated by changes in oxygenation/ventilation status, auscultation for wheezes and changes in ventilator loops. This is evaluated by experienced respiratory therapists and bedside nurses.
Number of infants who develop oral thrush that require treatment.
Time frame: The duration of study drug treatment (14 days).
Bedside nurses routinely evaluate for this common, mostly benign complication of prematurity. We will collect data on % of infants who develop oral thrush and % of infants that require topical treatment among infants exposed to inhaled ciclesonide and the control group.
Compare rates of BPD and severe BPD between cases and controls.
Time frame: BPD and severe BPD are ascertained at 36 weeks post-menstrual age.
Investigators will collect and report data on BPD and severity on each infant in the study irrespective of whether they were treated with inhaled ciclesonide or served as a control. We will also compare rates of BPD and severe BPD among the two groups.
Systemic Absorption of inhaled Ciclesonide
Time frame: Day 1, 3, 7, 15 of study (during drug administration).
Investigators will measure serum levels of ciclesonide and its active metabolite, des-ciclesonide 3 hour after inhaled drug administration (based on T1/2 in prior studies in children) in peripheral blood by mass spectrometry. This will provide us information on CIC to des-CIC conversion in preterm neonates, as well correlation with doses administered. Measured in picomol/ml (pmol/mL).
2 secondary outcomes
Compare rates of extubation success between infants exposed to study drug and controls receiving standard NICU clinical care
Time frame: Extubation rates will be calculated from the day of study drug initiation to 7 days after cessation of study drug, i.e., a 21 day window.
Assess changes in lung injury and need in mechanical ventilation support.
Time frame: Baseline, and daily from study drug initiation to 1 week after study drug cessation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Venkatesh Sampath, MD principal investigator
Children's Mercy Hospital Kansas City
Venkatesh Sampath, MD principal investigator
Physician-Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alvesco Inhalant Product in people with Bronchopulmonary Dysplasia, run by Venkatesh Sampath at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Venkatesh Sampath, MD (816-234-3596, vsampath@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hyperglycemia events (blood glucose >150mg/dL) during treatment. (time frame: Through study completion, an average of 4 months.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.