Phase 2
Completed N=7
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
Source: ClinicalTrials.gov NCT03332459 ↗Enrolled (actual)
7
Serious AEs
14.3%
Results posted
Apr 2021
Primary outcomePrimary: Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection — 0; 0; 0 percentage of participants
Summary
The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned study-related visit in a feeding Phase 2 study (64041575RSV2004).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection |
0; 0; 0 | — |
| PRIMARY Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection |
0.03; 0.00; 2.53 | — |
| SECONDARY Percentage of Wheezing Days in Participants Per Month After RSV Infection |
1.00; 0.00; 1.00; 0.00; 0.00; 1.00 | — |
| SECONDARY Number of Wheezing Episodes in Participants Per Month After the RSV Infection |
0.33; 0.00; 0.33; 0.00; 0.00; 0.33 | — |
| SECONDARY Number of Participants With Reportable Adverse Events (AEs) |
3; 1; 2 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
0; 0; 1 | — |
| SECONDARY Number of Respiratory Infections Per Participant |
10.7; 6.0; 19.5 | — |
| SECONDARY Number of Participants With Medical Encounters |
0; 0; 1; 3; 1; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT03332459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.