Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)

NCT00000575 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1041

Last updated 2014-04-03

Study results available
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Summary

The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.

Conditions

Interventions

DRUG

Placebo

Two 100 Og puffs budesonide placebo bid + two 90 Og puffs albuterol prn OR four 2 mg puffs nedocromil placebo bid + two 90 Og puffs albuterol prn.

DRUG

Nedocromil

Four 2 mg puffs bid + two 90 Og puffs albuterol prn

DRUG

Budesonide

Two 100 Og puffs bid + two 90 Og puffs albuterol prn.

Sponsors & Collaborators

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

    collaborator NIH
  • CAMP Steering Committee

    collaborator UNKNOWN
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • N. F. Adkinson, MD · Johns Hopkins University

  • Anne Fuhlbrigge, MD, MS · Brigham and Women's Hospital

  • H. W. Kelly, PharmD · University of New Mexico

  • Padmaja Subbarao, MD, MSc · The Hospital for Sick Children

  • Paul Williams, MD · Asthma, Inc.

  • Robert Strunk, MD · Washington University School of Medicine

  • Stanley Szefler, MD · National Jewish Health

  • James Tonascia, PhD · Johns Hopkins University

  • Robert Zeiger, MD, PhD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1991-09-30
Primary Completion
1999-10-31
Completion
2012-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000575 on ClinicalTrials.gov