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

Summary

Asthma affects about 4 million children in the United States and is a leading cause of hospitalizations and school absenteeism. Continuous wheezing in very young children may develop into asthma. Low doses of inhaled corticosteroids (ICS) are commonly prescribed to treat children with particularly bad wheezing episodes. This study will compare the safety and effectiveness of low doses of ICS taken daily versus higher doses of ICS taken only during respiratory tract illnesses for toddlers with continuous wheezing or coughing illnesses.

Conditions

• Asthma

Interventions

DRUG

Budesonide

Participants in Arm 1 will receive 0.5 mg of budesonide once a day. Participants in Arm 2 will receive 1 mg of budesonide twice a day for 7 days at the onset of respiratory tract illnesses.

DRUG

Placebo Budesonide

Participants in Arm 1 will receive placebo budesonide each morning during respiratory tract illnesses for 7 days. Participants in Arm 2 will receive placebo budesonide once a day for the entire study, other than when they have a respiratory tract illness.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• David T. Mauger, PhD · Penn State College of Medicine

• Stanley J. Szefler, MD, PhD · National Jewish Health

• Robert F. Lemanske, Jr., MD · University of Wisconsin, Madison

• Robert S. Zeiger, MD, PhD · Kaiser Permanente Medical Center

• Robert C. Strunk, MD · Washington University School of Medicine

• Fernando D. Martinez, MD · University of Arizona College of Medicine

• Lynn M. Taussig, MD · University of Denver

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

53 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-08-31

Primary Completion

2010-07-31

Completion

2010-07-31

Countries

• United States

Study Locations