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Childhood Asthma Research and Education (CARE) Network Trial - Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) (MIST)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00675584
First received: May 7, 2008
Last updated: February 24, 2013
Last verified: February 2013
History of Changes
Results First Received: April 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Budesonide
Drug: Placebo Budesonide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Daily 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.
Intermittent 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.

Participant Flow:   Overall Study
    Daily Budesonide     Intermittent Budesonide  
STARTED     139     139  
COMPLETED     100     113  
NOT COMPLETED     39     26  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Daily 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.
Intermittent 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.
Total Total of all reporting groups

Baseline Measures
    Daily Budesonide     Intermittent Budesonide     Total  
Number of Participants  
[units: participants]
 		  139     139     278  
Age  
[units: participants]
 		     
<=18 years     139     139     278  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation) 		  2.9  (0.9)     2.9  (0.9)     2.9  (0.9)  
Gender  
[units: participants]
 		     
Female     49     37     86  
Male     90     102     192  
Region of Enrollment  
[units: participants]
 		     
United States     139     139     278  



  Outcome Measures

1.  Primary:   Rate of Exacerbations Requiring Systemic Corticosteroids   [ Time Frame: Measured at Month 12 ]
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2.  Secondary:   Proportion of Episode-free Days   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Rate of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Time to Treatment Failure   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Exhaled Nitric Oxide Levels   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Changes in Pulmonary Reactance and Resistance   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Adverse Events Associated With Corticosteroid Use   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Absences From Daycare and Preschool for the Child and From Work for the Caregiver   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Rate of Rescue Albuterol Use   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Symptom Severity During Respiratory Tract Illness   [ Time Frame: Measured at 7 days for each respiratory tract illness ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Caregiver Quality of Life   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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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:  
Name/Title: Vernon M. Chinchilli, PhD
Organization: Penn State Hershey College of Medicine
phone: 717-531-4262
e-mail: vchinchi@psu.edu


Publications of Results:


Responsible Party: Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00675584     History of Changes
Other Study ID Numbers: 581
5U10HL064313 ( US NIH Grant/Contract Award Number )
5U10HL064288 ( US NIH Grant/Contract Award Number )
5U10HL064305 ( US NIH Grant/Contract Award Number )
5U10HL064295 ( US NIH Grant/Contract Award Number )
5U10HL064287 ( US NIH Grant/Contract Award Number )
5U10HL064307 ( US NIH Grant/Contract Award Number )
Study First Received: May 7, 2008
Results First Received: April 30, 2012
Last Updated: February 24, 2013
Health Authority: United States: Food and Drug Administration