Respiratory Syncytial Virus Infections
Conditions
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.
Interventions
DRUGLumicitabine
Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
DRUGPlacebo
Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
56 Days to 39 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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%. |
| 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. |
| 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. |
| 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. |
Countries
Japan
Participant flow
Pre-assignment details
Participants who previously received lumicitabine or placebo in study 64041575RSV2004 (NCT03333317) were enrolled in this long term follow-up (LTFU) study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 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. | 3 |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) 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. | 1 |
| Lumicitabine 60/40 mg/kg LD/MD 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. | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Placebo | Total | Lumicitabine 60/40 mg/kg LD/MD | Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) |
|---|---|---|---|---|
| Age, Continuous | 16 months STANDARD_DEVIATION 13.08 | 12 months STANDARD_DEVIATION 9.35 | 6.3 months STANDARD_DEVIATION 2.52 | 17 months |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 7 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment JAPAN | 3 Participants | 7 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 3 / 3 | 1 / 1 | 2 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 | 1 / 3 |
Outcome results
Primary
Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection
Percentage of participants with asthma diagnosed by physician were reported.
Time frame: Up to 2 years
Population: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this long term follow up (LTFU) study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection | 0 percentage of participants |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection | 0 percentage of participants |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection | 0 percentage of participants |
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.
Time frame: Up to 2 years
Population: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection | 0.03 percentage of wheezing days | Standard Deviation 0.058 |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection | 0.00 percentage of wheezing days | — |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection | 2.53 percentage of wheezing days | Standard Deviation 4.388 |
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.
Time frame: Up to 2 years
Population: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Medical Encounters | Hospital Inpatient Department Visits | 0 Participants |
| Placebo | Number of Participants With Medical Encounters | Medical Practitioner Office Visits | 2 Participants |
| Placebo | Number of Participants With Medical Encounters | Hospital Outpatient Department Visits | 3 Participants |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Participants With Medical Encounters | Hospital Inpatient Department Visits | 0 Participants |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Participants With Medical Encounters | Medical Practitioner Office Visits | 1 Participants |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Participants With Medical Encounters | Hospital Outpatient Department Visits | 1 Participants |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Participants With Medical Encounters | Medical Practitioner Office Visits | 1 Participants |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Participants With Medical Encounters | Hospital Outpatient Department Visits | 2 Participants |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Participants With Medical Encounters | Hospital Inpatient Department Visits | 1 Participants |
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.
Time frame: Up to 2 years
Population: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Reportable Adverse Events (AEs) | 3 Participants |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Participants With Reportable Adverse Events (AEs) | 1 Participants |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Participants With Reportable Adverse Events (AEs) | 2 Participants |
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.
Time frame: Up to 2 years
Population: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Respiratory Infections Per Participant
The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.
Time frame: Up to 2 years
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Respiratory Infections Per Participant | 10.7 infections per participant | Standard Deviation 4.62 |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Respiratory Infections Per Participant | 6.0 infections per participant | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Respiratory Infections Per Participant | 19.5 infections per participant | Standard Deviation 6.36 |
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.
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
Population: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 16 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 11 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 14 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 22 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 19 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 13 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 2 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 20 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 10 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 1 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 18 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 23 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 4 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 17 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 3 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 5 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 24 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 21 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 6 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 8 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 9 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 7 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 12 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Placebo | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 15 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 7 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 13 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 11 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 15 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 16 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 17 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 6 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 20 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 21 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 22 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 14 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 23 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 24 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 8 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 18 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 2 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 19 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 1 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 3 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 4 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 10 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 5 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 12 | 0.00 wheezing episodes per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 9 | 0.00 wheezing episodes per month | — |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 24 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 2 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 3 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 5 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 6 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 8 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 9 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 10 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 11 | 1.00 wheezing episodes per month | Standard Deviation 1.732 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 14 | 0.67 wheezing episodes per month | Standard Deviation 1.155 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 15 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 16 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 18 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 19 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 20 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 4 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 7 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 12 | 1.00 wheezing episodes per month | Standard Deviation 1.732 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 13 | 1.00 wheezing episodes per month | Standard Deviation 1.732 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 17 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 21 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 22 | 0.00 wheezing episodes per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 23 | 0.67 wheezing episodes per month | Standard Deviation 1.155 |
| Lumicitabine 60/40 mg/kg LD/MD | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Month 1 | 0.33 wheezing episodes per month | Standard Deviation 0.577 |
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%.
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
Population: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 12 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 2 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 4 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 5 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 6 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 10 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 13 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 14 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 15 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 17 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 22 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 23 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 24 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 1 | 1.00 percentage of wheezing days per month | Standard Deviation 1.732 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 3 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 7 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 8 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 9 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 11 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 16 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 18 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 19 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 20 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Placebo | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 21 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 23 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 19 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 11 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 4 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 3 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 16 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 5 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 6 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 8 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 22 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 18 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 10 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 7 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 12 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 13 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 14 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 1 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 15 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 2 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 24 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 20 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 9 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 21 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 17 | 0.00 percentage of wheezing days per month | — |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 5 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 22 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 23 | 4.00 percentage of wheezing days per month | Standard Deviation 6.928 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 24 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 17 | 4.00 percentage of wheezing days per month | Standard Deviation 6.928 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 2 | 1.00 percentage of wheezing days per month | Standard Deviation 1.732 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 3 | 5.67 percentage of wheezing days per month | Standard Deviation 9.815 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 6 | 2.00 percentage of wheezing days per month | Standard Deviation 3.464 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 7 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 18 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 9 | 4.33 percentage of wheezing days per month | Standard Deviation 7.506 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 10 | 3.33 percentage of wheezing days per month | Standard Deviation 5.774 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 4 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 13 | 6.33 percentage of wheezing days per month | Standard Deviation 10.97 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 19 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 11 | 5.00 percentage of wheezing days per month | Standard Deviation 8.66 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 8 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 1 | 1.00 percentage of wheezing days per month | Standard Deviation 1.732 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 12 | 5.67 percentage of wheezing days per month | Standard Deviation 9.815 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 14 | 4.33 percentage of wheezing days per month | Standard Deviation 7.506 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 16 | 7.67 percentage of wheezing days per month | Standard Deviation 13.279 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 15 | 6.00 percentage of wheezing days per month | Standard Deviation 10.392 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 20 | 1.00 percentage of wheezing days per month | Standard Deviation 1.732 |
| Lumicitabine 60/40 mg/kg LD/MD | Percentage of Wheezing Days in Participants Per Month After RSV Infection | Month 21 | 0.00 percentage of wheezing days per month | Standard Deviation 0 |