Synthetic Surfactant CHF5633 Compared with Poractant Alfa in the Treatment of Neonatal Respiratory Distress Syndrome: A Multicenter, Double-Blind, Randomized, Controlled Clinical Trial - 22/09/20
, Manoj Biniwale, MD 1, Krishnamurthy Sekar, MD 2, Nazeeh Hanna, MD 3, Sergio Golombek, MD 4, Jatinder Bhatia, MD 5, Martha Naylor, MD 6, Laura Fabbri, PhD 7, Guido Varoli, Pharm D 7, Debora Santoro, MSc 7, Dorothea Del Buono, MD 7, Annalisa Piccinno, MSc 7, Christiane E. Dammann, MD 8, ∗Abstract |
Objective |
To compare efficacy and safety of a new synthetic surfactant, CHF5633, enriched with surfactant proteins, SP-B and SP-C peptide analogues, with porcine surfactant, poractant alfa, for the treatment of respiratory distress syndrome in infants born preterm.
Study design |
Neonates born preterm on respiratory support requiring fraction of inspired oxygen (FiO2) ≥0.30 from 240/7 to 266/7 weeks and FiO2 ≥0.35 from 270/7 to 296/7 weeks of gestation to maintain 88%-95% oxygen saturation were randomized to receive 200 mg/kg of CHF5633 or poractant alfa. If necessary, redosing was given at 100 mg/kg. Efficacy end points were oxygen requirement (FiO2, respiratory severity score [FiO2 × mean airway pressure]) in the first 24 hours, 7 and 28 days, discharge home, and/or 36 weeks of postmenstrual age; mortality and bronchopulmonary dysplasia at 28 days and 36 weeks of PMA. Adverse events and immunogenicity were monitored for safety.
Results |
Of the 123 randomized neonates, 113 were treated (56 and 57 in CHF5633 and poractant alfa groups, respectively). In both arms, FiO2 and respiratory severity score decreased from baseline at all time points (P < .001) with no statistically significant differences between groups. Rescue surfactant use (19 [33.9%] vs 17 [29.8%]), bronchopulmonary dysplasia (31 [55.4%] and 32 [56.1%]), and mortality at day 28 (4 [7.1%] and 3 [5.3%]) were similar in the CHF5633 and poractant alfa groups, respectively. In 2 (3.4%) and 1 (1.7%) neonates, adverse drug reactions were reported in CHF5633 and poractant alfa groups, respectively. No immunogenicity was detected.
Conclusions |
Treatment with CHF5633 showed similar efficacy and safety as poractant alfa in neonates born preterm with moderate-to-severe respiratory distress syndrome.
Trial registration |
ClinicalTrials.gov: NCT02452476.
Le texte complet de cet article est disponible en PDF.Abbreviations : AE, ADR, BPD, BW, CHF5633, FiO2, MAP, OSI, PMA, RDS, RR, RSS, SpO2
Plan
| Sponsored by Chiesi Farmaceutici, SpA, Parma, Italy. R.R., M.B., K.S., N.H., S.G., J.B., M.N., and C.D. received clinical research funds from Chiesi Farmaceutici S.p.A. as site investigators for this study. R.R. is a member of Chiesi USA-Speaker's Bureau; received associated research funding from the NIH, University of Miami Miller School of Medicine, and University of Tasmania, Australia; is a joint patent holder for RAM Nasal Cannula, Neotech Products, Inc, USA and receives royalty payments. M.B. received associated research funding from Vyaire. C.D. received research funding from Vyaire. K.S. received associated research funding from Pfizer and Mallinckrodt Inc. S.G. received associated research funding from Mallinckrodt Inc. J.B. received associated research funding from Novartis. G.V., L.F., D.S., A.P., C.B., and D.B. are full employees of Chiesi Farmaceutici S.p.A.V.C. H.H., M.K., and T.S. declare no conflicts of interest; however, their institutions received a standard fee for their time dedicated for serving as members of the Independent Safe Monitoring Board from the Contract Research Organization, delegated by Chiesi Farmaceutici S.p.A. |
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| Portions of this study were presented at the Pediatric Academic Societies annual meeting, April 24-May 1, 2019, Baltimore, MD; and at the SPIN Congress, June 8, 2019, Parma, Italy. |
Vol 225
P. 90 - octobre 2020 Retour au numéro
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