Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.

Summary

This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. If a wheezing illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms using oral corticosteroids.

Conditions

• Asthma
• Wheezing

Interventions

DRUG

Azithromycin

Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day

DRUG

Prednisolone

Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

OTHER

Placebo Azithromycin

Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day

DRUG

Placebo Prednisolone

Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

Sponsors & Collaborators

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

  collaborator NIH

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• William B Busse, MD · University of Wisconsin, Madison

• Leonard B Bacharier, MD · Washington University School of Medicine

• Fernando D Martinez, MD · University of Arizona

• David T Mauger, PhD · Penn State University

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

• Wanda Phipatanakul, MD, MS · Boston Children's Hospital

• Jacqueline Pongracic, MD · Ann & Robert H Lurie Children's Hospital of Chicago

• David Gozal, MD · Comer Children's Hospital

• James Moy, MD · Rush University Medical Center

• Stanley Szefler, MD · National Jewish Health

• Hengameh Raissy, PharmD · University of New Mexico

• Elizabeth Bade, MD · Aurora Sinai Medical Center

• Fernando Holguin, MD · University of Pittsburgh

• James Chmiel, MD · Case Western Reserve University School of Medicine

• Michael Cabana, MD, MPH · University of California, San Francisco

• Mindy Benson, PNP · UCSF Benioff Children's Hospital Oakland

• W. Gerald Teague, MD · University of Virginia Health System

• Anne Fitzpatrick, MD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

71 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• United States

Study Locations