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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Sponsor:
Milton S. Hershey Medical Center
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Asthma |
Interventions |
Drug: Budesonide Drug: Placebo Budesonide |
Enrollment | 278 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Daily Budesonide | Intermittent Budesonide |
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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. | 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. |
Period Title: Overall Study | ||
Started | 139 | 139 |
Completed | 100 | 113 |
Not Completed | 39 | 26 |
Baseline Characteristics
Arm/Group Title | Daily Budesonide | Intermittent Budesonide | Total | |
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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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 139 | 139 | 278 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 139 participants | 139 participants | 278 participants | |
<=18 years |
139 100.0%
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139 100.0%
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278 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 139 participants | 139 participants | 278 participants | |
2.9 (0.9) | 2.9 (0.9) | 2.9 (0.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 139 participants | 139 participants | 278 participants | |
Female |
49 35.3%
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37 26.6%
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86 30.9%
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Male |
90 64.7%
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102 73.4%
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192 69.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 139 participants | 139 participants | 278 participants |
139 | 139 | 278 |
Outcome Measures
Adverse Events
Limitations and Caveats
May not be applicable to young children whose asthma is more severe than that of the children in the study. Daily or intermittent use of inhaled glucocorticoids may not be efficacious in preschool-age children with transient or infrequent wheezing.
More Information
Results Point of Contact
Name/Title: | Vernon M. Chinchilli, PhD |
Organization: | Penn State Hershey College of Medicine |
Phone: | 717-531-4262 |
EMail: | vchinchi@psu.edu |
Responsible Party: | Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center |
ClinicalTrials.gov Identifier: | NCT00675584 |
Other Study ID Numbers: |
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 ) |
First Submitted: | May 7, 2008 |
First Posted: | May 9, 2008 |
Results First Submitted: | April 30, 2012 |
Results First Posted: | June 1, 2012 |
Last Update Posted: | June 26, 2018 |