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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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]
<=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

1.  Primary:

Rate of Exacerbations Requiring Systemic Corticosteroids   [ Time Frame: Measured at Month 12 ]

2.  Secondary:

Proportion of Episode-free Days   [ Time Frame: Measured at Month 12 ]

3.  Secondary:

Rate of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma   [ Time Frame: Measured at Month 12 ]

4.  Secondary:

Time to Treatment Failure   [ Time Frame: Measured at Month 12 ]

5.  Secondary:

Changes in Exhaled Nitric Oxide Levels   [ Time Frame: Measured at Month 12 ]

6.  Secondary:

Changes in Pulmonary Reactance and Resistance   [ Time Frame: Measured at Month 12 ]

7.  Secondary:

Adverse Events Associated With Corticosteroid Use   [ Time Frame: Measured at Month 12 ]

8.  Secondary:

Absences From Daycare and Preschool for the Child and From Work for the Caregiver   [ Time Frame: Measured at Month 12 ]

9.  Secondary:

Rate of Rescue Albuterol Use   [ Time Frame: Measured at Month 12 ]

10.  Secondary:

Symptom Severity During Respiratory Tract Illness   [ Time Frame: Measured at 7 days for each respiratory tract illness ]

11.  Secondary:

Caregiver Quality of Life   [ Time Frame: Measured at Month 12 ]

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.