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

NCT03332459 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR1083752016-002095-2664041575RSV2002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

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).

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (2)

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

  Percentage of participants with asthma diagnosed by physician were reported.

  Up to 2 years

• Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection

  Percentage of wheezing days in participants within the first 2 Years after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days was calculated by (number of wheezing days/days of study completion - day of informed consent + 1)\*100.

  Up to 2 years

Secondary Outcomes (6)

• 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

• 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 Participants With Reportable Adverse Events (AEs)

  Up to 2 years

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 2 years

• Number of Respiratory Infections Per Participant

  Up to 2 years

Study Arms (2)

Lumicitabine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Lumicitabine DRUG

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

Lumicitabine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 56 Days - 39 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Fukuyama City Hospital

Fukuyama, 721-8511, Japan

Location

Hirosaki National Hospital

Hirosaki, 036-8545, Japan

Location

National Hospital Organization Niigata National Hospital

Niigata, 945-8585, Japan

Location

National Hospital Organization Beppu Medical Center

Ōita, 874-0011, Japan

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

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

Results Point of Contact

• Title: Medical Leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: November 6, 2017
• Study Start: January 5, 2018
• Primary Completion: April 13, 2020
• Study Completion: April 13, 2020
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-03

Locations

JP (4)