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Respiratory Syncytial Virus InfectionsPhase 2NCT03332459

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

A Phase 2 study testing Lumicitabine in people with Respiratory Syncytial Virus Infections, run by Janssen Research & Development, LLC at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned… Read more about this study

Who is it for?
Ages 56 days to 39 months
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
Lumicitabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7 participants
Where
4 sitesJapan
Study dates
5 Jan 2018to 13 Apr 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 56 days to 39 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Fukuyama City Hospital

    Fukuyama, 721-8511

  • Hirosaki National Hospital

    Hirosaki, 036-8545

  • National Hospital Organization Niigata National Hospital

    Niigata, 945-8585

  • National Hospital Organization Beppu Medical Center

    Ōita, 874-0011

Other trials in Japan

About this study

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

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).

Read the 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.

Being tested
Lumicitabine, Placebo
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LumicitabineDrug

    Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.

  • PlaceboDrug

    Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.

Study groups in NCT03332459
Study groupRoleWhat they receive
LumicitabineExperimentalParticipants 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.
Receives: Drug: Lumicitabine
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection

    Percentage of participants with asthma diagnosed by physician were reported.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

Secondary outcomes (6)

  1. 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%.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: Up to 2 years

  4. 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.

    Measured: Up to 2 years

  5. Number of Respiratory Infections Per Participant

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

    Measured: Up to 2 years

  6. 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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start5 Jan 2018
  3. Primary completion13 Apr 2020
  4. Study completion13 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03332459
Sponsor's protocol ID
CR108375
Other IDs
2016-002095-26, 64041575RSV2002, 2016
Status last verified
Mar 2021
First submitted
16 Oct 2017
Last updated
13 Apr 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lumicitabine in people with Respiratory Syncytial Virus Infections, run by Janssen Research & Development, LLC at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03332459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.

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