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CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) (MIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00675584
Recruitment Status : Completed
First Posted : May 9, 2008
Results First Posted : June 1, 2012
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center

Study Type Interventional
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description 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
Arm/Group Title Daily Budesonide Intermittent Budesonide Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 139 participants 278 participants
<=18 years
139
 100.0%
139
 100.0%
278
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 139 participants 139 participants 278 participants
Female
49
  35.3%
37
  26.6%
86
  30.9%
Male
90
  64.7%
102
  73.4%
192
  69.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 139 participants 139 participants 278 participants
139 139 278
1.Primary Outcome
Title Rate of Exacerbations Requiring Systemic Corticosteroids
Hide Description The rate of exacerbations was calculated as the number of exacerbations requiring prednisone per years of follow-up
Time Frame Measured during the 12-month follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the numerator and denominator of the exacerbation rate
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Mean (95% Confidence Interval)
Unit of Measure: events per years of follow-up
0.97
(0.76 to 1.22)
0.95
(0.75 to 1.20)
2.Secondary Outcome
Title Proportion of Episode-free Days
Hide Description An episode-free day consisted of no asthma symptoms and no asthma rescue medications
Time Frame Measured during the 12-month follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the numerator and denominator of the proportion of episode-free days
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Mean (95% Confidence Interval)
Unit of Measure: proportion of episode-free days
0.78
(0.76 to 0.81)
0.78
(0.75 to 0.80)
3.Secondary Outcome
Title Number of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma Per 12 Months
Hide Description [Not Specified]
Time Frame Measured during the 12-month follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of urgent care visits
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Mean (95% Confidence Interval)
Unit of Measure: visits per 12 months
2.40
(1.91 to 3.02)
2.37
(1.89 to 2.97)
4.Secondary Outcome
Title Number of Participants With Treatment Failure
Hide Description

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 rationale
Time Frame Measured during the 12-month follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
Even if a child terminated prior to completion of the 12 months of follow-up, his/her data were included in the assessment of treatment failure
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Measure Type: Count of Participants
Unit of Measure: Participants
17
  12.2%
9
   6.5%
5.Secondary Outcome
Title Change Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO)
Hide Description Exhaled nitric oxide (eNO) is measured in parts per billion, and the change constructed between 12 months and baseline
Time Frame baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Even if a child terminated prior to completion of the 12 months of follow-up, his/her data were included in the analysis based on the linear mixed-effects model
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Least Squares Mean (95% Confidence Interval)
Unit of Measure: parts per billion
-0.14
(-0.32 to 0.04)
-0.18
(-0.38 to 0.02)
6.Secondary Outcome
Title Change Between 12 Months and Baseline in Pulmonary Reactance and Resistance Measured Via Oscillometry
Hide Description [Not Specified]
Time Frame baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Prior to enrollment of the first randomized study participant, the clinical investigators decided that it would be futile to perform oscillometry in children of the target age range for MIST (2-5 years of age). A previous CARE Network trial (PEAK) performed oscillometry in such children, but the data were highly variable and of poor quality.
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Adverse Events Associated With Corticosteroid Use
Hide Description [Not Specified]
Time Frame Measured during the 12-month follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized children are included
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Measure Type: Count of Participants
Unit of Measure: Participants
3
   2.2%
0
   0.0%
8.Secondary Outcome
Title Number of Days of Absence From Daycare and Preschool for the Child and From Work for the Caregiver Per 12 Months
Hide Description [Not Specified]
Time Frame Measured during the 12-month follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of days
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Mean (95% Confidence Interval)
Unit of Measure: days per 12 months
3.02
(2.22 to 4.12)
2.72
(2.00 to 3.70)
9.Secondary Outcome
Title Proportion of Days With Rescue Albuterol Use
Hide Description [Not Specified]
Time Frame Measured during the 12-month follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of days
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Mean (95% Confidence Interval)
Unit of Measure: proportion of days
0.05
(0.04 to 0.06)
0.06
(0.05 to 0.07)
10.Secondary Outcome
Title Change in Wheeze Severity During a Respiratory Tract Illness
Hide Description Wheeze severity is scored as 0 (none) to 5 (very severe) during a respiratory tract illness
Time Frame Measured during the first seven days for each respiratory tract illness
Hide Outcome Measure Data
Hide Analysis Population Description
The data from every respiratory tract illness is included in the analysis
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.5
(0.1 to 0.8)
0.8
(0.5 to 1.1)
11.Secondary Outcome
Title Change Between 12 Months and Baseline in the Caregiver Quality-of-life
Hide Description 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
Time Frame baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Even if a child terminated prior to completion of the 12 months of follow-up, his/her data were included in the analysis based on the linear mixed-effects model
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 139 139
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.4
(-3.0 to 5.8)
2.0
(-1.8 to 5.8)
Time Frame 1 year
Adverse Event Reporting Description does not differ from the clinicaltrials.gov definitions
 
Arm/Group Title Daily Budesonide Intermittent Budesonide
Hide Arm/Group Description 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.
All-Cause Mortality
Daily Budesonide Intermittent Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Daily Budesonide Intermittent Budesonide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/139 (5.04%)      10/139 (7.19%)    
Injury, poisoning and procedural complications     
other   3/139 (2.16%)  3 5/139 (3.60%)  5
Respiratory, thoracic and mediastinal disorders     
hospitalization due to exacerbation   4/139 (2.88%)  4 5/139 (3.60%)  5
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daily Budesonide Intermittent Budesonide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/139 (6.47%)      11/139 (7.91%)    
Gastrointestinal disorders     
nausea or vomiting *  9/139 (6.47%)  9 11/139 (7.91%)  11
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vernon M. Chinchilli, PhD
Organization: Penn State Hershey College of Medicine
Phone: 717-531-4262
EMail: vchinchi@psu.edu
Layout table for additonal information
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