A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants

Wheezing Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Motavizumab Prophylaxis on Reduction of the Incidence of Serious Early Childhood Wheezing in Preterm Infants

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00628303
• Other study ID #: MI-CP169
• Status: Withdrawn
• Phase: Phase 3
• First received: February 20, 2008
• Last updated: July 30, 2012
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.

Description:

The primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection during the first RSV season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Male or female infants born at 32 & 1/7 - 35 & 0/7 weeks GA, determined according to available medical records

• Chronological age of <6 months of age at randomization

• In good health, in the opinion of the investigator

• Not more than one of the following AAP-defined risk factors:

1. Childcare attendance

2. School-aged siblings

3. Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)

• Ability and willingness of the subject's parent/legal guardian to complete all protocol-mandated follow-up telephone contacts, visits and procedures

• Written informed consent obtained from the subject's parent(s) or legal guardian

Exclusion Criteria:

• Diagnosis of CLD of prematurity (also referred to as BPD) or other chronic pulmonary diseases

• Diagnosis of hemodynamically significant CHD, defined as requiring medication or supplemental oxygen for their CHD

• Congenital abnormalities of the airways

• Severe neuromuscular disease, as determined by the investigator

• Previous or concurrent treatment with palivizumab or intravenous immunoglobulin (IVIG)

• Eligible for prophylaxis based on local medical standards and guidelines at participating sites

• Known immunodeficiency

• Previous or current diagnosis of an upper or lower respiratory infection by a medical professional

• Previous or current diagnosis of wheezing, asthma, or other wheezing-related diagnoses

• Hospitalization at the time of enrollment (in case admitted to nursery as part of routine care, infant should only be randomized immediately prior to being discharged)

• Any illness or condition that would preclude long-term survival

• Participation in a trial or an investigational agent for RSV prophylaxis or therapy

• Inability to be followed through their 3rd birthday

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wheezing

Intervention

Biological:
• Motavizumab
15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections

Other:
• Placebo
15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of serious early childhood wheezing episodes		Between 2nd and 3rd birthdays	No
Secondary	Frequency of medically-attended lower respiratory tract wheezing events		During 2nd and 3rd birthday	No
Secondary	Frequency of medically-attended lower respiratory tract wheezing events from randomization through 3 years of age		From randomization through 3 yrs.	No
Secondary	Incidence of serious RSV disease		Through Day 150	No