Clinical trial NCT03332459: 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
Official title: A Long-term Follow-up of Study 64041575RSV2004 to Evaluate the Impact of Lumicitabine (JNJ-64041575) on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 7
Sex: ALL
Minimum age (years): 56
Maximum age (years): 39
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

Detailed description: RSV is a leading cause of lower respiratory tract disease in infants. The primary hypothesis is that treatment of RSV-infected infants/children with lumicitabine (also known as JNJ-64041575 or ALS-008176) will decrease subsequent wheezing/asthma compared to placebo (looks like lumicitabine). The participants who have completed treatment course (lumicitabine/placebo) and last study visit in a previous study, 64041575RSV2004, for the treatment of RSV infection will be enrolled in this LTFU study. The main purpose of this study is to understand the impact of lumicitabine on the occurrence of asthma/wheezing in infants/children with a history of RSV infection. The participants will be assessed via monthly calls with the parents/caregivers and also at site visits at 3, 6,12 and 24 months.

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

Primary outcomes:
measure: Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection
timeFrame: Up to 2 years
measure: Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection
timeFrame: Up to 2 years
Secondary outcomes:
measure: Percentage of Wheezing Days in Participants Per Month After RSV Infection
timeFrame: Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
measure: Number of Wheezing Episodes in Participants Per Month After the RSV Infection
timeFrame: Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
measure: Number of Participants With Reportable Adverse Events (AEs)
timeFrame: Up to 2 years
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 2 years
measure: Number of Respiratory Infections Per Participant
timeFrame: Up to 2 years
measure: Number of Participants With Medical Encounters
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Fukuyama
country: Japan
facility: Fukuyama City Hospital
city: Hirosaki
country: Japan
facility: Hirosaki National Hospital
city: Niigata
country: Japan
facility: National Hospital Organization Niigata National Hospital
city: Oita
country: Japan
facility: National Hospital Organization Beppu Medical Center
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: