Trial · NCT03969992
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
NCT03969992, Phase 2, Completed, Aerogen Pharma Limited; results first posted 2025-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact. Trials, record NCT03969992. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03969992
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
- NCT number
- NCT03969992
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 261 participants, actual
- Lead sponsor
- Aerogen Pharma Limited
- Conditions
- Respiratory Distress Syndrome in Premature Infant
- Interventions
- AeroFact, nCPAP
- First posted
- 2019-05-31
- Last updated
- 2025-08-07
- Results first posted
- 2025-08-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intubation/Cannulation and Instilled Surfactant | First 7 days of life | Number of patients who require intubation/cannulation with bolus surfactant instillation |
| Secondary | Time to First Intubation/Cannulation and Bolus Surfactant Instillation | First 7 days of life | Time from randomization to intubation/cannulation and bolus surfactant instillation in the first 7 days of life |
| Secondary | Proportion of Infants Who Received Multiple Doses of Bolus Surfactant | First 7 days of life | |
| Secondary | Number of Days on Invasive Mechanical Ventilation | Assessed daily from birth to 40 weeks post-menstrual age or discharge | Total number of days each participant required support with invasive mechanical ventilation |
| Secondary | Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA) | Birth to 36 weeks post-menstrual age | Total number of patients per treatment group who were alive and did not experience BPD at 36 weeks PMA |
| Secondary | Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA) | Birth to 40 weeks post-menstrual age | Total number of patients per treatment group who were alive and did not experience BPD at 40 weeks PMA |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intubation/Cannulation and Instilled Surfactant | First 7 days of life | Per Protocol population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Intubation/Cannulation and Bolus Surfactant Instillation | First 7 days of life | Per protocol population | hours | MEDIAN |
| SECONDARY | Proportion of Infants Who Received Multiple Doses of Bolus Surfactant | First 7 days of life | Per protocol population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Days on Invasive Mechanical Ventilation | Assessed daily from birth to 40 weeks post-menstrual age or discharge | Per protocol population | Days | MEAN |
| SECONDARY | Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA) | Birth to 36 weeks post-menstrual age | Per protocol population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA) | Birth to 40 weeks post-menstrual age | Per protocol population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intubation/Cannulation and Instilled Surfactant | Control: nCPAP Alone | 45 | Participants | ||
| Intubation/Cannulation and Instilled Surfactant | Drug: Low Dose AeroFact | 21 | Participants | ||
| Intubation/Cannulation and Instilled Surfactant | Drug: High Dose AeroFact | 26 | Participants | ||
| Time to First Intubation/Cannulation and Bolus Surfactant Instillation | Control: nCPAP Alone | 17.5 | Full Range 2.0 to 53.9 | hours | |
| Time to First Intubation/Cannulation and Bolus Surfactant Instillation | Drug: Low Dose AeroFact | 13.6 | Full Range 3.2 to 43.4 | hours | |
| Time to First Intubation/Cannulation and Bolus Surfactant Instillation | Drug: High Dose AeroFact | 22.4 | Full Range 1.8 to 53.7 | hours | |
| Proportion of Infants Who Received Multiple Doses of Bolus Surfactant | Control: nCPAP Alone | 7 | Participants | ||
| Proportion of Infants Who Received Multiple Doses of Bolus Surfactant | Drug: Low Dose AeroFact | 1 | Participants | ||
| Proportion of Infants Who Received Multiple Doses of Bolus Surfactant | Drug: High Dose AeroFact | 5 | Participants | ||
| Number of Days on Invasive Mechanical Ventilation | Control: nCPAP Alone | 4.8 | Standard Deviation 7.1 | Days |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Birth to Discharge/40 Weeks PMA | STARTED | Control: nCPAP Alone | 92 | |
| Part 1: Birth to Discharge/40 Weeks PMA | STARTED | Drug: Low Dose AeroFact | 83 | |
| Part 1: Birth to Discharge/40 Weeks PMA | STARTED | Drug: High Dose AeroFact | 86 | |
| Part 1: Birth to Discharge/40 Weeks PMA | COMPLETED | Control: nCPAP Alone | 89 | |
| Part 1: Birth to Discharge/40 Weeks PMA | COMPLETED | Drug: Low Dose AeroFact | 80 | |
| Part 1: Birth to Discharge/40 Weeks PMA | COMPLETED | Drug: High Dose AeroFact | 81 | |
| Part 1: Birth to Discharge/40 Weeks PMA | NOT COMPLETED | Control: nCPAP Alone | 3 | |
| Part 1: Birth to Discharge/40 Weeks PMA | NOT COMPLETED | Drug: Low Dose AeroFact | 3 | |
| Part 1: Birth to Discharge/40 Weeks PMA | NOT COMPLETED | Drug: High Dose AeroFact | 5 | |
| Part 2: Discharge/40 Wks PMA to 12 Mos | STARTED | Control: nCPAP Alone | 89 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Intraventricular hemorrhage neonatal | Nervous system disorders | Control: nCPAP Alone | 6 | 92 | |
| other | Intraventricular hemorrhage neonatal | Nervous system disorders | Drug: Low Dose AeroFact | 15 | 83 | |
| other | Intraventricular hemorrhage neonatal | Nervous system disorders | Drug: High Dose AeroFact | 18 | 86 | |
| other | Retinopathy or prematurity | Eye disorders | Control: nCPAP Alone | 14 | 92 | |
| other | Retinopathy or prematurity | Eye disorders | Drug: Low Dose AeroFact | 13 | 83 | |
| other | Retinopathy or prematurity | Eye disorders | Drug: High Dose AeroFact | 13 | 86 | |
| other | Pneumothorax | Respiratory, thoracic and mediastinal disorders | Control: nCPAP Alone | 3 | 92 | |
| other | Pneumothorax | Respiratory, thoracic and mediastinal disorders | Drug: Low Dose AeroFact | 5 | 83 | |
| other | Pneumothorax | Respiratory, thoracic and mediastinal disorders | Drug: High Dose AeroFact | 4 | 86 | |
| other | Infantile apnea | Respiratory, thoracic and mediastinal disorders | Control: nCPAP Alone | 3 | 92 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control: nCPAP Alone | 2 | 92 |
| Total, all-cause mortality | Drug: Low Dose AeroFact | 3 | 83 |
| Total, all-cause mortality | Drug: High Dose AeroFact | 2 | 86 |
| Total, other adverse events | Control: nCPAP Alone | 43 | 92 |
| Total, other adverse events | Drug: Low Dose AeroFact | 45 | 83 |
| Total, other adverse events | Drug: High Dose AeroFact | 42 | 86 |
| Total, serious adverse events | Control: nCPAP Alone | 7 | 92 |
| Total, serious adverse events | Drug: Low Dose AeroFact | 9 | 83 |
| Total, serious adverse events | Drug: High Dose AeroFact | 5 | 86 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42442657 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03969992
GET https://conductscience.org/api/trials/v1/NCT03969992/events?page=2