Phase 3 Study of Inhaled Human Interferon Alpha 1b to Treat Respiratory Syncytial Virus Infection in Children Under 2 Years

What this Trial Is About

This research aims to evaluate the safety and effectiveness of interferon 1b GB05 inhalation solution in treating children under 2 years old who have respiratory syncytial virus RSV infections affecting their lower respiratory tract. The study is a phase III, randomized, double-blind, placebo-controlled clinical trial focused on this young patient group with moderate to severe bronchiolitis symptoms. Participants are randomly assigned to one of three groups receiving nebulized human interferon 1b inhalation solution at either 4 gkg or 6 gkg doses twice daily, or a placebo, all administered for up to 7 days. After evaluating the safety and effectiveness of these doses, the study will confirm the optimal dose and adjust the sample size for the next part of the trial. Throughout the study, children will be monitored with regular assessments including the Wang bronchiolitis score measured at day 5 and throughout treatment, and RSV viral load from before dosing up to 120 hours after. Parents or guardians will provide informed consent, and safety evaluations will include clinical examinations and laboratory tests. Participation involves careful observation over the treatment period and follow-up to assess treatment impact and safety.

Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections