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Trial Underway Testing Preterm Respiratory Treatment

Baby in neonatal unit

(Pacific Northwest National Lab)

30 December 2015. A clinical trial testing new treatment methods for a common respiratory disorder faced by preterm babies began enrolling patients. The trial is testing an aerosol-delivered surfactant, a wetting agent applied to the lungs of babies born prematurely without natural surfactants to keep open air sacs in lungs, made by Discovery Laboratories a biotechnology company in Warrington, Pennsylvania.

Preterm infants born 6 weeks early or more often have a condition called respiratory distress syndrome, where their lungs do not produce surfactants that reduce the surface tension of fluid lining air sacs in the lungs. Without these surfactants, air sacs collapse rather than stay open, and babies must immediately receive surfactant replacement therapy to enable breathing.

Discovery Laboratories develops synthetic surfactants for treating respiratory distress syndrome that contains peptides similar in structure and that act like natural lung surfactants. Because of the fragile condition of many preterm babies, physicians are sometimes reluctant to use liquid surfactants, since they require insertion of a tube in the windpipe, which the baby might not be able to support. Instead, physicians choose a less invasive method, known as nasal continuous positive airway pressure or nCPAP, that sends air into the lungs through prongs in the baby’s nostrils.

Discovery Laboratories first developed a liquid suspension called lucinactant, approved by FDA in 2012 to treat respiratory distress syndrome and marketed by the company as Surfaxin. Because of Surfaxin’s limitations with many preterm babies, the company later produced a formulation of lucinactant in aerosol form that can be mixed with air given to babies receiving nCPAP. Discovery Laboratories calls this product Aerosurf, which it tested in early-stage safety trials.

The new clinical study is an intermediate-stage trial testing Aerosurf with babies born in 26 to 32 weeks, receiving nCPAP therapy for respiratory distress syndrome. The company plans to enroll 240 preterm infants at 8 sites in the U.S., with more sites planned in Canada, Europe, and Latin America.

Patients will be randomly assigned to receive Aerosurf surfactant in high or low doses with nCPAP therapy, or receive nCPAP therapy alone. The study team is looking primarily for the ability of babies with respiratory distress syndrome to remain on nCPAP therapy, instead of switching to liquid lucinactant delivered through a tube to the lungs.

Earlier in December, Discovery Laboratories presented results of another intermediate-stage trial of Aerosurf at a meeting of neonatology physicians. That study mainly investigated safety of the Aerosurf treatments in preterm infants compared to nCPAP therapy alone. The findings, says the company, show Aerosurf treatments were no less safe nor tolerated any worse than nCPAP alone. In addition, more babies receiving Aerosurf in the trial were able to continue with nCPAP therapy than those receiving only nCPAP treatments.

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