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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 : January 23, 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

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 		 139   139   278 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation) 		 2.9  (0.9)   2.9  (0.9)   2.9  (0.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      49  35.3%      37  26.6%      86  30.9% 
Male      90  64.7%      102  73.4%      192  69.1% 
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 ]
  Show Outcome Measure 1

2.  Secondary:   Proportion of Episode-free Days   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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.  

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

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

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

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

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.  

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

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.  

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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 ( 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: January 23, 2018