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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332459
• Other study ID #: CR108375
• Secondary ID: 2016-002095-2664
• Status: Completed
• Phase: Phase 2
• Start date: January 5, 2018
• Est. completion date: April 13, 2020

Study information

• Verified date: March 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 13, 2020
• Est. primary completion date: April 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 56 Days to 39 Months

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Sounds
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• Lumicitabine
Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
• Placebo
Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.

Locations

Country	Name	City	State
Japan	Fukuyama City Hospital	Fukuyama
Japan	Hirosaki National Hospital	Hirosaki
Japan	National Hospital Organization Niigata National Hospital	Niigata
Japan	National Hospital Organization Beppu Medical Center	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection	Percentage of participants with asthma diagnosed by physician were reported.	Up to 2 years
Primary	Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection	Percentage of wheezing days in participants within the first 2 Years after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days was calculated by (number of wheezing days/days of study completion - day of informed consent + 1)*100.	Up to 2 years
Secondary	Percentage of Wheezing Days in Participants Per Month After RSV Infection	Percentage of wheezing days in participants per month after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days per month was calculated by number of days reported in that period with wheezing, using last day - first day + 1 for reported days of wheezing and multiplied by 100%.	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
Secondary	Number of Wheezing Episodes in Participants Per Month After the RSV Infection	Number of wheezing episodes in participants per month after the RSV infection based on information reported by the parent/caregiver were reported.	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
Secondary	Number of Participants With Reportable Adverse Events (AEs)	Number of participants with reportable AEs were reported. The following AEs were considered reportable (within the context of this study): respiratory illness AEs, including subsequent RSV infections, adverse events considered at least possibly related to study treatment (lumicitabine or placebo, as received in study 64041575RSV2004), and serious adverse events.	Up to 2 years
Secondary	Number of Participants With Serious Adverse Events (SAEs)	SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.	Up to 2 years
Secondary	Number of Respiratory Infections Per Participant	The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.	Up to 2 years
Secondary	Number of Participants With Medical Encounters	Number of participants with medical encounters (hospital inpatient department visits, hospital outpatient department visits, medical practitioner office visits) was reported based on information reported by the parent/caregiver.	Up to 2 years