A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection
Respiratory Syncytial Virus Infections
About this trial
This is an interventional other trial for Respiratory Syncytial Virus Infections
Eligibility Criteria
Inclusion Criteria:
- Male or female infants and children who were previously randomized in study 64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and who completed the planned course of the study drug and the last study-related visit of study 64041575RSV2004
- The participant's legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing for the participant to participate in the study
Exclusion Criteria:
- The participants legally acceptable representative, i.e, parent/legal guardian/caregiver, is not able to maintain reliable communication with the investigator
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Sites / Locations
- Fukuyama City Hospital
- Hirosaki National Hospital
- National Hospital Organization Niigata National Hospital
- National Hospital Organization Beppu Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lumicitabine
Placebo
Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing lumicitabine for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.
Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing placebo for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage.