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

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03332459
• Collaborator: (none)
• Enrollment: 7
• Locations: 4
• Arms: 2
• Actual Duration (Months): 27.2
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infections	Drug: Lumicitabine; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jan 5, 2018
• Actual Primary Completion Date: Apr 13, 2020
• Actual Study Completion Date: Apr 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lumicitabine 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.	Drug: Lumicitabine; Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
Placebo Comparator: Placebo 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.	Drug: Placebo; Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection [Up to 2 years]

   Percentage of participants with asthma diagnosed by physician were reported.

2. Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection [Up to 2 years]

   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

1. Percentage of Wheezing Days in Participants Per Month After RSV Infection [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]

   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%.

2. Number of Wheezing Episodes in Participants Per Month After the RSV Infection [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]

   Number of wheezing episodes in participants per month after the RSV infection based on information reported by the parent/caregiver were reported.

3. Number of Participants With Reportable Adverse Events (AEs) [Up to 2 years]

   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.

4. Number of Participants With Serious Adverse Events (SAEs) [Up to 2 years]

   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.

5. Number of Respiratory Infections Per Participant [Up to 2 years]

   The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.

6. Number of Participants With Medical Encounters [Up to 2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 56 Days to 39 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fukuyama City Hospital	Fukuyama		Japan	721-8511
2	Hirosaki National Hospital	Hirosaki		Japan	036-8545
3	National Hospital Organization Niigata National Hospital	Niigata		Japan	945-8585
4	National Hospital Organization Beppu Medical Center	Oita		Japan	874-0011

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

• Study Protocol - Jan 30, 2018
• Statistical Analysis Plan - May 11, 2020

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03332459
• Other Study ID Numbers: CR108375; 2016-002095-26; 64041575RSV2002
• First Posted: Nov 6, 2017
• Last Update Posted: Apr 13, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Respiratory Sounds

Study Results

Participant Flow

Pre-assignment Detail	Participants who previously received lumicitabine or placebo in study 64041575RSV2004 (NCT03333317) were enrolled in this long term follow-up (LTFU) study.

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
Period Title: Overall Study
STARTED	3	1	3
COMPLETED	3	1	3
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD	Total
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Total of all reporting groups
Overall Participants	3	1	3	7
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	16 (13.08)	17 (NA)	6.3 (2.52)	12 (9.35)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	1 33.3%	1 14.3%
Male	3 100%	1 100%	2 66.7%	6 85.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	2 66.7%	1 100%	2 66.7%	5 71.4%
Unknown or Not Reported	1 33.3%	0 0%	1 33.3%	2 28.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	3 100%	1 100%	3 100%	7 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
JAPAN	3 100%	1 100%	3 100%	7 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this long term follow up (LTFU) study.

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
Measure Participants	3	1	3
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
Measure Participants	3	1	3
Mean (Standard Deviation) [percentage of wheezing days]	0.03 (0.058)	0.00 (NA)	2.53 (4.388)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
Measure Participants	3	1	3
Month 1	1.00 (1.732)	0.00 (NA)	1.00 (1.732)
Month 2	0.00 (0.00)	0.00 (NA)	1.00 (1.732)
Month 3	0.00 (0.00)	0.00 (NA)	5.67 (9.815)
Month 4	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 5	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 6	0.00 (0.00)	0.00 (NA)	2.00 (3.464)
Month 7	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 8	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 9	0.00 (0.00)	0.00 (NA)	4.33 (7.506)
Month 10	0.00 (0.00)	0.00 (NA)	3.33 (5.774)
Month 11	0.00 (0.00)	0.00 (NA)	5.00 (8.660)
Month 12	0.00 (0.00)	0.00 (NA)	5.67 (9.815)
Month 13	0.00 (0.00)	0.00 (NA)	6.33 (10.970)
Month 14	0.00 (0.00)	0.00 (NA)	4.33 (7.506)
Month 15	0.00 (0.00)	0.00 (NA)	6.00 (10.392)
Month 16	0.00 (0.00)	0.00 (NA)	7.67 (13.279)
Month 17	0.00 (0.00)	0.00 (NA)	4.00 (6.928)
Month 18	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 19	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 20	0.00 (0.00)	0.00 (NA)	1.00 (1.732)
Month 21	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 22	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 23	0.00 (0.00)	0.00 (NA)	4.00 (6.928)
Month 24	0.00 (0.00)	0.00 (NA)	0.00 (0.00)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
Measure Participants	3	1	3
Month 1	0.33 (0.577)	0.00 (NA)	0.33 (0.577)
Month 2	0.00 (0.00)	0.00 (NA)	0.33 (0.577)
Month 3	0.00 (0.00)	0.00 (NA)	0.33 (0.577)
Month 4	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 5	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 6	0.00 (0.00)	0.00 (NA)	0.33 (0.577)
Month 7	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 8	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 9	0.00 (0.00)	0.00 (NA)	0.33 (0.577)
Month 10	0.00 (0.00)	0.00 (NA)	0.33 (0.577)
Month 11	0.00 (0.00)	0.00 (NA)	1.00 (1.732)
Month 12	0.00 (0.00)	0.00 (NA)	1.00 (1.732)
Month 13	0.00 (0.00)	0.00 (NA)	1.00 (1.732)
Month 14	0.00 (0.00)	0.00 (NA)	0.67 (1.155)
Month 15	0.00 (0.00)	0.00 (NA)	0.33 (0.577)
Month 16	0.00 (0.00)	0.00 (NA)	0.33 (0.577)
Month 17	0.00 (0.00)	0.00 (NA)	0.33 (0.577)
Month 18	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 19	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 20	0.00 (0.00)	0.00 (NA)	0.33 (0.577)
Month 21	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 22	0.00 (0.00)	0.00 (NA)	0.00 (0.00)
Month 23	0.00 (0.00)	0.00 (NA)	0.67 (1.155)
Month 24	0.00 (0.00)	0.00 (NA)	0.00 (0.00)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
Measure Participants	3	1	3
Count of Participants [Participants]	3 100%	1 100%	2 66.7%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
Measure Participants	3	1	3
Count of Participants [Participants]	0 0%	0 0%	1 33.3%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study. Here 'N' (number of participants analyzed) included all participants who had a respiratory infection.

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
Measure Participants	3	1	2
Mean (Standard Deviation) [infections per participant]	10.7 (4.62)	6.0 (0.00)	19.5 (6.36)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.

Arm/Group Title	Placebo	Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.	Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
Measure Participants	3	1	3
Hospital Inpatient Department Visits	0 0%	0 0%	1 33.3%
Hospital Outpatient Department Visits	3 100%	1 100%	2 66.7%
Medical Practitioner Office Visits	2 66.7%	1 100%	1 33.3%

Adverse Events

Time Frame	Up to 2 years (during this long term follow up study)
Adverse Event Reporting Description	Reportable AEs (Respiratory illness AEs, including subsequent RSV infections, AEs considered at least possibly related to study treatment [lumicitabine or placebo, as received in Study 64041575RSV2004], and serious adverse events) reported below. All Enrolled analysis set: all participants from 64041575RSV2004 study enrolled in this LTFU study.
Arm/Group Title	Placebo		Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)		Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.		Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.		Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.
All Cause Mortality
	Placebo		Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)		Lumicitabine 60/40 mg/kg LD/MD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)		0/3 (0%)
Serious Adverse Events
	Placebo		Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)		Lumicitabine 60/40 mg/kg LD/MD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Gastrointestinal disorders
Enterocolitis	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Inguinal Hernia	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Infections and infestations
Exanthema Subitum	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Gastroenteritis Norovirus	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Gastroenteritis Rotavirus	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Oral Herpes	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Other (Not Including Serious) Adverse Events
	Placebo		Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)		Lumicitabine 60/40 mg/kg LD/MD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		1/1 (100%)		2/3 (66.7%)
Infections and infestations
Adenovirus Infection	1/3 (33.3%)		0/1 (0%)		0/3 (0%)
Bronchitis	2/3 (66.7%)		1/1 (100%)		1/3 (33.3%)
Enterocolitis Viral	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Exanthema Subitum	1/3 (33.3%)		0/1 (0%)		0/3 (0%)
Nasopharyngitis	1/3 (33.3%)		0/1 (0%)		1/3 (33.3%)
Pharyngitis	2/3 (66.7%)		1/1 (100%)		1/3 (33.3%)
Rhinitis	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Tonsillitis	1/3 (33.3%)		0/1 (0%)		0/3 (0%)
Upper Respiratory Tract Infection	1/3 (33.3%)		1/1 (100%)		1/3 (33.3%)
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic	1/3 (33.3%)		0/1 (0%)		0/3 (0%)
Rhinorrhoea	1/3 (33.3%)		0/1 (0%)		0/3 (0%)
Upper Respiratory Tract Inflammation	2/3 (66.7%)		0/1 (0%)		0/3 (0%)
Wheezing	1/3 (33.3%)		0/1 (0%)		1/3 (33.3%)
Skin and subcutaneous tissue disorders
Eczema	2/3 (66.7%)		0/1 (0%)		0/3 (0%)

Limitations/Caveats

Due to the limited number of participants enrolled in this study (n=7), no meaningful conclusions can be made.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.