CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) (MIST)
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ClinicalTrials.gov Identifier: NCT00675584 |
Recruitment Status :
Completed
First Posted : May 9, 2008
Results First Posted : June 1, 2012
Last Update Posted : June 26, 2018
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Tracking Information | ||||||||||||||||||||||
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First Submitted Date ICMJE | May 7, 2008 | |||||||||||||||||||||
First Posted Date ICMJE | May 9, 2008 | |||||||||||||||||||||
Results First Submitted Date ICMJE | April 30, 2012 | |||||||||||||||||||||
Results First Posted Date ICMJE | June 1, 2012 | |||||||||||||||||||||
Last Update Posted Date | June 26, 2018 | |||||||||||||||||||||
Study Start Date ICMJE | August 2008 | |||||||||||||||||||||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Rate of Exacerbations Requiring Systemic Corticosteroids [ Time Frame: 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
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Original Primary Outcome Measures ICMJE |
Rate of exacerbations requiring systemic corticosteroids [ Time Frame: Measured at Month 12 ] | |||||||||||||||||||||
Change History | ||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||
Descriptive Information | ||||||||||||||||||||||
Brief Title ICMJE | CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) | |||||||||||||||||||||
Official Title ICMJE | Childhood Asthma Research and Education (CARE) Network Trial - Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) | |||||||||||||||||||||
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:
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. |
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Study Type ICMJE | Interventional | |||||||||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Asthma | |||||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Zeiger RS, Mauger D, Bacharier LB, Guilbert TW, Martinez FD, Lemanske RF Jr, Strunk RC, Covar R, Szefler SJ, Boehmer S, Jackson DJ, Sorkness CA, Gern JE, Kelly HW, Friedman NJ, Mellon MH, Schatz M, Morgan WJ, Chinchilli VM, Raissy HH, Bade E, Malka-Rais J, Beigelman A, Taussig LM; CARE Network of the National Heart, Lung, and Blood Institute. Daily or intermittent budesonide in preschool children with recurrent wheezing. N Engl J Med. 2011 Nov 24;365(21):1990-2001. doi: 10.1056/NEJMoa1104647. | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||||||||
Actual Enrollment ICMJE |
278 | |||||||||||||||||||||
Original Estimated Enrollment ICMJE |
250 | |||||||||||||||||||||
Actual Study Completion Date ICMJE | July 2010 | |||||||||||||||||||||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Eligibility Criteria ICMJE | 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.
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:
Participants who meet any of the following criteria are NOT eligible for enrollment, and they may not be re-enrolled:
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:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Months to 53 Months (Child) | |||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||
Listed Location Countries ICMJE | United States | |||||||||||||||||||||
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Administrative Information | ||||||||||||||||||||||
NCT Number ICMJE | NCT00675584 | |||||||||||||||||||||
Other Study ID Numbers ICMJE | 581 5U10HL064313 ( U.S. NIH Grant/Contract ) 5U10HL064288 ( U.S. NIH Grant/Contract ) 5U10HL064305 ( U.S. NIH Grant/Contract ) 5U10HL064295 ( U.S. NIH Grant/Contract ) 5U10HL064287 ( U.S. NIH Grant/Contract ) 5U10HL064307 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||
Current Responsible Party | Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center | |||||||||||||||||||||
Original Responsible Party | David T. Mauger, PhD, The Pennsylvania State University, College of Medicine | |||||||||||||||||||||
Current Study Sponsor ICMJE | Milton S. Hershey Medical Center | |||||||||||||||||||||
Original Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | |||||||||||||||||||||
Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | |||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Milton S. Hershey Medical Center | |||||||||||||||||||||
Verification Date | May 2018 | |||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |