CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)
Condition: Asthma
MeSH terms: Asthma; Respiratory Sounds
Intervention: Budesonide; Placebo Budesonide
Intervention description: Participants in Arm 1 will receive 0.5 mg of budesonide once a day. Participants in Arm 2 will receive 1 mg of budesonide twice a day for 7 days at the onset of respiratory tract illnesses.; Participants in Arm 1 will receive placebo budesonide each morning during respiratory tract illnesses for 7 days. Participants in Arm 2 will receive placebo budesonide once a day for the entire study, other than when they have a respiratory tract illness.
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 278.0
Sex: All
Minimum age: 12 Months
Maximum age: 53 Months
Healthy volunteers: No

Summary:

      Asthma affects about 4 million children in the United States and is a leading cause of
      hospitalizations and school absenteeism. Continuous wheezing in very young children may
      develop into asthma. Low doses of inhaled corticosteroids (ICS) are commonly prescribed to
      treat children with particularly bad wheezing episodes. This study will compare the safety
      and effectiveness of low doses of ICS taken daily versus higher doses of ICS taken only
      during respiratory tract illnesses for toddlers with continuous wheezing or coughing
      illnesses.
    

Eligibility criteria:

        Inclusion Criteria at Screening Visit:

        Participants who meet all of the following criteria are eligible for study entry.
        Participants may be reassessed if not initially eligible.

          -  Positive asthma predictive index (API) status

          -  A history of at least 4 wheezing episodes in the prior year with at least one
             physician diagnosed or at least 3 wheezing episodes in the prior year with at least
             one physician diagnosed and at least 3 months of asthma controller therapy in the
             prior year

          -  Experienced a severe exacerbation requiring systemic corticosteroids, urgent
             unscheduled or emergency visit, or hospitalization in the 12 months before the
             screening visit

          -  All immunizations must be completed, including varicella (unless the child has already
             had clinical varicella). If the child needs the varicella vaccine, this will be
             arranged with the primary care physician and must be received before study entry.

          -  Allows blood to be used for genetic analysis

          -  Willingness to provide informed consent by the child's parent or guardian

        Exclusion Criteria at Screening Visit:

        Participants who meet any of the following criteria are NOT eligible for enrollment, but
        they may be re-enrolled if these exclusion criteria disappear:

          -  Use of more than six courses of systemic corticosteroids in the 12 months before the
             screening visit

          -  More than two hospitalizations for wheezing illnesses in the 12 months before the
             screening visit

          -  Use of oral or systemic corticosteroids in the 2 weeks before the screening visit

          -  Current treatment with antibiotics for diagnosed sinus disease

          -  Current participation or has participated in the month before the screening visit in
             another investigational drug trial

          -  Evidence that the family may be unreliable or nonadherent, or may move from the
             clinical center area before trial completion

          -  Medically unable to use systemic corticosteroids

          -  Clinically relevant gastroesophageal reflux

          -  Inability of the child to cooperate with nebulizer therapy

        Participants who meet any of the following criteria are NOT eligible for enrollment, and
        they may not be re-enrolled:

          -  Gestation less than late preterm, as defined as birth before 34 weeks gestational age

          -  Significant developmental delay/failure to thrive, defined as crossing of two major
             percentile lines during the last year for age and gender. If a child plots less than
             the 10th percentile for age and gender, a growth chart for the previous year will be
             obtained from the child's primary care provider.

          -  Head circumference less than the 3rd percentile or greater than the 97th percentile
             unless medical evaluation documents no associated illness

          -  Presence of lung disease other than asthma, such as cystic fibrosis and
             bronchopulmonary dysplasia (BPD). Evaluation during the screening process will assure
             that an adequate evaluation of other lung diseases has been performed.

          -  Presence of other significant medical illnesses (e.g., cardiac, liver,
             gastrointestinal, endocrine) that would place the child at increased risk of
             participating in the study

          -  Immunodeficiency disorders

          -  History of respiratory failure requiring mechanical ventilation

          -  History of hypoxic seizure

          -  History of significant adverse reaction to any study medication ingredient

        Exclusion Criteria at Baseline Visit:

        Participants will be ineligible to continue in the study and be randomly assigned to a
        treatment group if any of the following is documented during the 2-week observation period,
        but they may be re-enrolled if these exclusion criteria disappear:

          -  Persistent symptomatic asthma, as defined as experiencing symptoms requiring albuterol
             use on average three or more days per week or two or more night time awakenings due to
             asthma-associated symptoms

          -  Inadequate adherence (less than 75% of days) to diary card completion or nebulizer
             medication use

          -  Use of any asthma medication except albuterol (used on as needed basis)