CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)
- Registration Number
- NCT00675584
- Lead Sponsor
- Milton S. Hershey Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Budesonide Budesonide Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days. Budesonide Budesonide Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study. Budesonide Placebo Budesonide Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study. Placebo Budesonide Placebo Budesonide Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
- Primary Outcome Measures
Name Time Method Rate of Exacerbations Requiring Systemic Corticosteroids Measured during the 12-month follow-up period The rate of exacerbations was calculated as the number of exacerbations requiring prednisone per years of follow-up
- Secondary Outcome Measures
Name Time Method Adverse Events Associated With Corticosteroid Use Measured during the 12-month follow-up period Proportion of Episode-free Days Measured during the 12-month follow-up period An episode-free day consisted of no asthma symptoms and no asthma rescue medications
Number of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma Per 12 Months Measured during the 12-month follow-up period Number of Participants With Treatment Failure Measured during the 12-month follow-up period Treatment failure was defined as the occurrence of at least one of the following events:
1. four courses of systemic corticosteroids
2. one hospitalization for acute exacerbation of wheezing
3. hypoxic seizure during an acute exacerbation of asthma/wheezing
4. intubation for acute asthma/wheezing
5. serious adverse event related to a study medication
6. physician discretion with specific rationaleChange Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO) baseline and 12 months Exhaled nitric oxide (eNO) is measured in parts per billion, and the change constructed between 12 months and baseline
Change Between 12 Months and Baseline in Pulmonary Reactance and Resistance Measured Via Oscillometry baseline and 12 months Number of Days of Absence From Daycare and Preschool for the Child and From Work for the Caregiver Per 12 Months Measured during the 12-month follow-up period Proportion of Days With Rescue Albuterol Use Measured during the 12-month follow-up period Change in Wheeze Severity During a Respiratory Tract Illness Measured during the first seven days for each respiratory tract illness Wheeze severity is scored as 0 (none) to 5 (very severe) during a respiratory tract illness
Change Between 12 Months and Baseline in the Caregiver Quality-of-life baseline and 12 months The caregiver quality-of-life questionnaire consists of seven questions, each scored from 0 (worse) to 3 (best), and all seven questions are summed to yield a total score ranging from 0 to 21
Trial Locations
- Locations (5)
University of Arizona College of Medicine
🇺🇸Tucson, Arizona, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
National Jewish Medical and Research Center
🇺🇸Denver, Colorado, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States
Kaiser Permanente Medical Center
🇺🇸San Diego, California, United States