Trial · NCT00675584
CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)
NCT00675584, Phase 3, Completed, Milton S. Hershey Medical Center; results first posted 2012-06-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST). Trials, record NCT00675584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00675584
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CARE Network Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST)
- NCT number
- NCT00675584
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 278 participants, actual
- Lead sponsor
- Milton S. Hershey Medical Center
- Conditions
- Asthma
- Interventions
- Budesonide, Placebo Budesonide
- First posted
- 2008-05-09
- Last updated
- 2018-06-26
- Results first posted
- 2012-06-01
- 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.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | 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 | |
| Secondary | 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 rationale |
| Secondary | Change 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 |
| Secondary | Change Between 12 Months and Baseline in Pulmonary Reactance and Resistance Measured Via Oscillometry | baseline and 12 months | |
| Secondary | Adverse Events Associated With Corticosteroid Use | Measured during the 12-month follow-up period | |
| Secondary | 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 | |
| Secondary | Proportion of Days With Rescue Albuterol Use | Measured during the 12-month follow-up period | |
| Secondary | 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Exacerbations Requiring Systemic Corticosteroids | Measured during the 12-month follow-up period | 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 | events per years of follow-up | MEAN |
| SECONDARY | Proportion of Episode-free Days | Measured during the 12-month follow-up period | 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 | proportion of episode-free days | MEAN |
| SECONDARY | 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 | 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 | visits per 12 months | MEAN |
| SECONDARY | Number of Participants With Treatment Failure | Measured during the 12-month follow-up period | 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 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO) | baseline and 12 months | 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 | parts per billion | LEAST_SQUARES_MEAN |
| SECONDARY | Change Between 12 Months and Baseline in Pulmonary Reactance and Resistance Measured Via Oscillometry | baseline and 12 months | 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. | ||
| SECONDARY | Adverse Events Associated With Corticosteroid Use | Measured during the 12-month follow-up period | All randomized children are included | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of days | days per 12 months | MEAN |
| SECONDARY | Proportion of Days With Rescue Albuterol Use | Measured during the 12-month follow-up period | Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the number of days | proportion of days | MEAN |
| SECONDARY | Change in Wheeze Severity During a Respiratory Tract Illness | Measured during the first seven days for each respiratory tract illness | The data from every respiratory tract illness is included in the analysis | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Exacerbations Requiring Systemic Corticosteroids | Daily Budesonide | 0.97 | 95% Confidence Interval 0.76 to 1.22 | events per years of follow-up | |
| Rate of Exacerbations Requiring Systemic Corticosteroids | Intermittent Budesonide | 0.95 | 95% Confidence Interval 0.75 to 1.20 | events per years of follow-up | |
| Proportion of Episode-free Days | Daily Budesonide | 0.78 | 95% Confidence Interval 0.76 to 0.81 | proportion of episode-free days | |
| Proportion of Episode-free Days | Intermittent Budesonide | 0.78 | 95% Confidence Interval 0.75 to 0.80 | proportion of episode-free days | |
| Number of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma Per 12 Months | Daily Budesonide | 2.40 | 95% Confidence Interval 1.91 to 3.02 | visits per 12 months | |
| Number of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma Per 12 Months | Intermittent Budesonide | 2.37 | 95% Confidence Interval 1.89 to 2.97 | visits per 12 months | |
| Number of Participants With Treatment Failure | Daily Budesonide | 17 | Participants | ||
| Number of Participants With Treatment Failure | Intermittent Budesonide | 9 | Participants | ||
| Change Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO) | Daily Budesonide | -0.14 | 95% Confidence Interval -0.32 to 0.04 | parts per billion | |
| Change Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO) | Intermittent Budesonide | -0.18 | 95% Confidence Interval -0.38 to 0.02 | parts per billion |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daily Budesonide | 139 | |
| Overall Study | STARTED | Intermittent Budesonide | 139 | |
| Overall Study | COMPLETED | Daily Budesonide | 100 | |
| Overall Study | COMPLETED | Intermittent Budesonide | 113 | |
| Overall Study | NOT COMPLETED | Daily Budesonide | 39 | |
| Overall Study | NOT COMPLETED | Intermittent Budesonide | 26 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea or vomiting | Gastrointestinal disorders | Daily Budesonide | 9 | 139 | 9 |
| other | nausea or vomiting | Gastrointestinal disorders | Intermittent Budesonide | 11 | 139 | 11 |
| serious | hospitalization due to exacerbation | Respiratory, thoracic and mediastinal disorders | Daily Budesonide | 4 | 139 | 4 |
| serious | hospitalization due to exacerbation | Respiratory, thoracic and mediastinal disorders | Intermittent Budesonide | 5 | 139 | 5 |
| serious | other | Injury, poisoning and procedural complications | Daily Budesonide | 3 | 139 | 3 |
| serious | other | Injury, poisoning and procedural complications | Intermittent Budesonide | 5 | 139 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daily Budesonide | ||
| Total, all-cause mortality | Intermittent Budesonide | ||
| Total, other adverse events | Daily Budesonide | 9 | 139 |
| Total, other adverse events | Intermittent Budesonide | 11 | 139 |
| Total, serious adverse events | Daily Budesonide | 7 | 139 |
| Total, serious adverse events | Intermittent Budesonide | 10 | 139 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22111718 | RESULT |
Source PubMed
Grants6
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10HL064287 | CARE Network--St. Louis Center | STRUNK, ROBERT | WASHINGTON UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 1999 to 2008 | NIH RePORTER |
| U10HL064288 | Childhood Asthma Research and Education Network: Denver Site | SZEFLER, STANLEY J. | NATIONAL JEWISH HEALTH | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 1999 to 2008 | NIH RePORTER |
| U10HL064295 | CARE Network-UCSD Clinical Center | ZEIGER, ROBERT S | UNIVERSITY OF CALIFORNIA, SAN DIEGO | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 1999 to 2008 | NIH RePORTER |
| U10HL064305 | CARE Network - Madison Clinical Center | LEMANSKE, ROBERT F | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 1999 to 2008 | NIH RePORTER |
| U10HL064307 | CARE Network - Tucson Clinical Center | MARTINEZ, FERNANDO D | UNIVERSITY OF ARIZONA | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 1999 to 2008 | NIH RePORTER |
| U10HL064313 | Pediatric Asthma Network Data coordinating Center | MAUGER, DAVID T. | PENNSYLVANIA STATE UNIV HERSHEY MED CTR | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 1999 to 2008 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Daily Budesonide vs Intermittent Budesonide: Number of Participants With Treatment Failure | Trial comparisons |
| Daily Budesonide vs Intermittent Budesonide: Adverse Events Associated With Corticosteroid Use | Trial comparisons |
| Daily Budesonide vs Intermittent Budesonide: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00675584
GET https://conductscience.org/api/trials/v1/NCT00675584/registered