A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if treatment with a medication called Nucala®
      (mepolizumab), given along with standard asthma care, makes children less likely to have
      asthma attacks.
    

Detailed description: 
      Asthma is a growing problem, especially in children. It causes frequent wheezing, shortness
      of breath, chest tightness, and cough. Asthma attacks, or exacerbations, are problems for
      children with asthma.

      The purpose of this study is to see if treatment with a medication called mepolizumab
      (Nucala®), given along with standard asthma care, makes children less likely to have asthma
      attacks. Mepolizumab is a new drug that is approved by the Food and Drug Administration (FDA)
      for use in children with asthma who are aged 12 years and older. Mepolizumab is given by
      injection. It is being studied by other researchers in children aged 6-11 years.

      All participants will be prescribed standard asthma medications by a clinician who is trained
      in asthma care. Medications will include controller medications, a rescue medication, and a
      medication for severe asthma attacks (prednisone). The amount of medication that participants
      receive may be increased or decreased during the study based on their symptoms and breathing
      test results. Study clinicians will treat all participants according to the same guidelines.
      These treatment guidelines are based on recommendations from a group of national experts in
      asthma. This study has been designed this way so that all participants will have safe and
      effective standard asthma care.

      In order to enroll in this study, participants must be willing to have their asthma managed
      by the study clinician during the entire study period. Participants must also be willing to
      bring study medications to all study visits.

      This study will include up to 20 study visits. Participant involvement in the study will
      endure for approximately 1 year.

      During the treatment period, participants will be placed in one of two treatment groups:

        -  Mepolizumab injection and guidelines-based asthma care or

        -  Placebo injection and guidelines-based asthma care.

      Participants will not be able to choose which group they are assigned. This assignment is
      random and by chance, much like flipping a coin. Participants will not know if they are
      receiving mepolizumab or placebo. Investigators will compare the study results between the
      participants of each group.
    

Intervention name(s): Mepolizumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of:
100 mg for participants ≥12 years of age and
40 mg for participants ages 6 to 11 years and weighing ≥40 kg.
Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.
Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.; Placebo administered every 4 weeks by subcutaneous injection at a dose of:
100 mg for participants ≥12 years of age and
40 mg for participants ages 6 to 11 years and weighing ≥40 kg.
Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.
Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study.
Other intervention name(s): Nucala®; anti-Interleukin 5 (IL5) antagonist monoclonal antibody; Placebo for Mepolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: urban setting; children and adolescents; double-masked, placebo-controlled randomized trial; asthma exacerbations (attacks); mepolizumab adjunctive therapy; asthma exacerbations prevention; difficult-to-control exacerbation-prone asthma