Back to resultsA 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
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Lumicitabine
Placebo
Sponsored by
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
Arm Type
Experimental
Placebo Comparator
Arm Label
Lumicitabine
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection
Percentage of participants with asthma diagnosed by physician were reported.
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.
Secondary Outcome Measures
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%.
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.
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.
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.
Number of Respiratory Infections Per Participant
The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.
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.
Full Information
NCT ID
NCT03332459
First Posted
October 16, 2017
Last Updated
March 18, 2021
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03332459
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
April 13, 2020 (Actual)
Study Completion Date
April 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumicitabine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lumicitabine
Intervention Description
Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
Primary Outcome Measure Information:
Title
Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection
Description
Percentage of participants with asthma diagnosed by physician were reported.
Time Frame
Up to 2 years
Title
Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Description
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%.
Time Frame
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
Title
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Description
Number of wheezing episodes in participants per month after the RSV infection based on information reported by the parent/caregiver were reported.
Time Frame
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
Title
Number of Participants With Reportable Adverse Events (AEs)
Description
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.
Time Frame
Up to 2 years
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 2 years
Title
Number of Respiratory Infections Per Participant
Description
The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.
Time Frame
Up to 2 years
Title
Number of Participants With Medical Encounters
Description
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.
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Days
Maximum Age & Unit of Time
39 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Fukuyama City Hospital
City
Fukuyama
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Hirosaki National Hospital
City
Hirosaki
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
National Hospital Organization Niigata National Hospital
City
Niigata
ZIP/Postal Code
945-8585
Country
Japan
Facility Name
National Hospital Organization Beppu Medical Center
City
Oita
ZIP/Postal Code
874-0011
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
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
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