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AeroFact for Sleep Apnea

Phase 2
Waitlist Available
Research Sponsored by Aerogen Pharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight <2.0 Kg
26 0/7 to 30 6/7 weeks of gestational age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new inhaler for treating sleep apnea.

Who is the study for?
This trial is for newborns with Respiratory Distress Syndrome, born between 26 and nearly 31 weeks of gestation, weighing less than 2 kg. They must have a specific level of respiratory distress but not too severe that they required extensive resuscitation at birth or have other significant health issues like genetic anomalies.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of AeroFact, an aerosolized medication delivered through nCPAP (a type of breathing support), in two different doses to help babies with Respiratory Distress Syndrome breathe easier.See study design
What are the potential side effects?
While the side effects are not explicitly listed here, common concerns may include irritation or inflammation in the airways, reactions to the drug's components, or potential impacts on breathing due to the delivery method.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is less than 2.0 Kg.
Select...
I am between 26 and 30 weeks pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of intubation/cannulation and instilled surfactant
Oxygen
Percent of patients with respiratory symptoms requiring intervention across groups
Secondary outcome measures
Percent of patients requiring repeat surfactant dosing between groups

Trial Design

3Treatment groups
Experimental Treatment
Group I: nCPAP aloneExperimental Treatment1 Intervention
Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary
Group II: Drug: Low Dose AeroFactExperimental Treatment1 Intervention
AeroFact-low dose SF-RI 1
Group III: Drug: High Dose AeroFactExperimental Treatment1 Intervention
AeroFact-high dose SF-RI 1

Find a Location

Who is running the clinical trial?

Aerogen Pharma LimitedLead Sponsor
2 Previous Clinical Trials
26 Total Patients Enrolled
Andy Clark, PhDStudy DirectorAerogen Pharma Corp

Media Library

AeroFact (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03969992 — Phase 2
Respiratory Distress Syndrome Research Study Groups: Drug: High Dose AeroFact, Drug: Low Dose AeroFact, nCPAP alone
Respiratory Distress Syndrome Clinical Trial 2023: AeroFact Highlights & Side Effects. Trial Name: NCT03969992 — Phase 2
AeroFact (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03969992 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there several hospitals running this trial in the metropolitan area?

"The University of Washington in Seattle, the University of Maryland in Baltimore, South Miami Hospital in Miami are a few examples of the 33 active sites for this study."

Answered by AI

Are we still able to enroll individuals in this experiment?

"Yes, the most recent information available on clinicaltrials.gov suggests that this trial is still looking for enrollees. The original posting was on March 4th 2020 and it has been updated as recently as February 22nd of this year. There are a total of 33 different sites where 261 patients can be enrolled in the study."

Answered by AI

Have similar studies been conducted in the past?

"At the moment, the only ongoing AeroFact study is located in 33 cities across 2 nations. The first trial for this occurred in 2020 and was completed Phase 2 drug approval stage. In total, 261 patients were involved in the original study that was sponsored by Aerogen Pharma Limited. Since then, 13 more trials have been carried out."

Answered by AI

Is this research being conducted with elderly individuals?

"The age requirement for this clinical trial is 26-31 weeks."

Answered by AI

What is the clinical evidence for AeroFact's efficacy?

"AeroFact was first trialed in 2020 at West Chester Medical Center-Maria Fareri Children's Hospital. As of now, there have been 13 completed trials with 1 study still recruiting patients. The majority of these trials are based out of Seattle, Washington."

Answered by AI

Are there any specific requirements to join this clinical trial?

"This study is accepting 261 patients that have respiratory distress syndrome and are aged between 26 weeks to 31 weeks."

Answered by AI

What is the status of AeroFact's drug approval from the FDA?

"Although there is some data supporting AeroFact's safety, it has not been proven to be effective yet. Therefore, our team at Power rates its safety as a 2."

Answered by AI

What is the recruitment goal for this research project?

"That is correct. According to the listing on clinicaltrials.gov, this trial has an open recruitment status. The first posting date was March 4th, 2020 with the most recent update being February 22nd, 2022. 261 individuals are needed for the 33 different locations participating in the study."

Answered by AI

Who else is applying?

What site did they apply to?
University of Illinois
Women's Hospital of Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Need some help on certain things.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
2020. "A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03969992.
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~51 spots leftby May 2025
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