CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)
Condition: Asthma
MeSH terms: Asthma; Respiratory Sounds
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Childhood asthma can be caused by many factors, including allergens, cigarette smoke, air
      pollution, or infections. Symptoms include wheezing, shortness of breath, chest tightness,
      and coughing. Wheezing illnesses are common during the first several years of life, and
      continuous wheezing, or recurrent intermittent wheezing, may be an indicator of asthma.
      Recurrent intermittent wheezing can also lead to breathing difficulties, sleep disturbances,
      and severe exacerbations that result in emergency department visits, hospitalizations, or
      even death. The Prevention of Early Asthma in Kids (PEAK) and Acute Intervention Management
      Strategies (AIMS) studies, both of which are part of the Childhood Asthma Research and
      Education (CARE) Network, as well as several other studies, have identified therapies that
      may improve recurrent wheezing in young children. This study will compare the safety and
      effectiveness of two treatment regimens-low doses of ICS taken on a daily basis versus higher
      doses of ICS taken only during respiratory tract illnesses-at improving recurrent wheezing in
      toddlers. Study researchers will also identify individual characteristics (e.g., age, gender,
      family history of asthma and allergies, the degree of allergy, genetics) that may be
      associated with treatment response. Lastly, the relationship of virus infections to
      respiratory illnesses, wheezing episodes, and response to study treatments will also be
      studied.

      This study will enroll children between 12 and 53 months of age who have experienced episodes
      of wheezing or coughing in the year before study entry, with at least one episode that
      required one of the following: oral steroids, an urgent unscheduled medical visit, an
      emergency room visit, or hospitalization. This study will begin with a 2-week evaluation
      period during which potential participants will receive placebo once a day. Parents will
      document their child's asthma symptoms and medication use in a daily diary. Next, at a
      baseline study visit, eligible participants will be randomly assigned to one of the following
      two 12-month treatment groups:

        -  Group 1 participants will receive a low dose of ICS once a day at night, except during
           respiratory tract illnesses. During a respiratory tract illness, participants will
           receive placebo each morning and a low dose of ICS each night for 7 days.

        -  Group 2 participants will receive a high dose of ICS twice a day for 7 days during each
           respiratory illness and placebo once a day at night at all other times.

      Throughout the 12 months of treatment, all participants will receive albuterol to treat
      respiratory symptoms and prednisolone if asthma symptoms worsen. Parents will be given an
      action plan to help manage their child's symptoms, and during respiratory illnesses, parents
      will contact study researchers to determine the best treatment plan. Study visits will occur
      at baseline and Weeks 4, 12, 20, 28, 36, 44, and 52. Participants' parents will take part in
      scheduled telephone interviews one month after each clinic visit to provide information on
      their child's asthma symptoms, study medication use, and health problems. Most study visits
      will include a physical exam and lung function testing. At select study visits, the following
      will occur: allergy skin testing, blood collection, nasal mucus sampling, and parent
      questionnaires to assess asthma, quality of life, and environmental factors. A portion of the
      participants' blood will undergo genetic analysis; a blood collection from parents for
      genetic analysis will be optional. Throughout the treatment period, participants' parents
      will record asthma symptoms and medication usage in a daily diary.
    

Intervention name(s): Budesonide; Placebo Budesonide
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Pulmicort Respules®; Placebo Pulmicort Respules®
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment