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

This study has been completed.
Sponsor:
Collaborators:
CAMP Steering Committee
Information provided by (Responsible Party):
James Tonascia, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00000575
First received: October 27, 1999
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Lung Diseases
Drug: Placebo
Drug: Nedocromil
Drug: Budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Childhood Asthma Management Program

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period [ Time Frame: At the end of treatment, 4-6 years from baseline assessment ] [ Designated as safety issue: No ]
    Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). Percent predicted determined from three separate published sets of reference equations for white, black, and Hispanic children - see NEJM 343: 1054-1062, 2000 for more details and references.


Secondary Outcome Measures:
  • Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]
    Bronchial responsiveness to serial concentrations of inhaled methacholine solution (mg/ml) as measured by serial ratios of follow-up to baseline FEV1 (forced volume of air expired from the lungs in one second). A dose-response curve is calculated from the serial ratios in relation to the serial concentrations to determine PC20, the concentration associated with a 20% drop from baseline in FEV1; this PC20 is the outcome measure with units mg/ml of methacholine.

  • Change From Baseline in the Rate of Asthma Free Days [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]
    Change from baseline proportion of days without asthma symptoms or other asthma related events to proportion of days during the 4-6 years of follow-up. Asthma free days were determined from daily asthma diaries kept from baseline to the end of treatment, 4-6 years later.

  • Need for Urgent Care for Asthma [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]
    Counts during the period of treatment (4-6 years) of visits to emergency rooms or equivalent urgent care settings for asthma treatment.

  • Mortality [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: Yes ]
    Counts of deaths from asthma.

  • Change in Height From Baseline to End of Treatment, 4-6 Years Later [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]
    Change in standing height from baseline to end of treatment. Standing height is measured three times without shoes using a calibrated Harpenden stadiometer; the average of the three repeated heights to the nearest 0.1 cm is the height measure at either baseline or end of treatment.

  • Standardized Depression Scale -- Children's Depression Inventory [ Time Frame: 4-6 years from baseline ] [ Designated as safety issue: No ]
    Change in total score on the Children's Depression Inventory from baseline to the end of treatment, 4-6 years later. The total score ranges from 0-54 with higher scores indicating greater levels of depression.


Enrollment: 1041
Study Start Date: September 1991
Study Completion Date: March 2012
Primary Completion Date: October 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Budesonide
Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
Drug: Budesonide
Two 100 Og puffs bid + two 90 Og puffs albuterol prn.
Other Name: Pulmicort
Active Comparator: 2 Nedocromil
Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
Drug: Nedocromil
Four 2 mg puffs bid + two 90 Og puffs albuterol prn
Other Name: Tilade
Placebo Comparator: 3 Placebo
Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 5 to 12 years at time of screening
  • Chronic asthma as evidenced by one or more of the following historical findings for at least 6 months during the past year:
  • Asthma symptoms at least 2 times per week
  • 2 or more usages per week of an inhaled bronchodilator
  • Daily asthma medication
  • Current asthma symptoms either by diary symptom code of 1 or greater or am or pm PEFR less than 80% of personal best post-bronchodilator value by diary, on 8 or more days during the prn screening period
  • Methacholine sensitivity: estimated PC20 FEV1 less than or equal to 12.5 mg/ml
  • Consent of guardian and assent of child
  • Ability to comply with trial for 5 - 6.5 years

Exclusion criteria:

  • Presence of one or more of the following confounding or complicating problems:
  • Any other active pulmonary disease
  • Any chronic condition presumed to interfere with the successful completion of the project or confound its interpretation
  • Pulmonary function testing findings suggesting a ventilatory defect other than asthma, or evidence of existing irreversible lung damage
  • Severe chronic sinusitis or nasal polyposis
  • Introduction of or a change in allergen immunotherapy within the past month
  • Use of more than 4 sprays of nasal steroids daily (only beclomethasone allowed)
  • Pregnancy
  • Current use of metoclopramide, ranitidine, or cimetidine
  • Treatment for gastroesophageal reflux
  • Participation in another drug study
  • Evidence of severe asthma as indicated by one or more of the following:
  • Two or more hospitalizations for asthma in the past year
  • Six or more steroid bursts in the past year
  • Demonstrated need for continuous use of glucocorticoids, either oral or inhaled
  • When off inhaled O2-agonist for more than 4 hrs and theophylline for more than 24 hrs, FEV1 less than 65% predicted
  • Intubation for asthma at any time in the past
  • Need for 9 or more puffs/day of albuterol for each of 3 consecutive days (excluding preventive use prior to exercise), or nocturnal asthma awakenings more than 1.5 times per week on average, or average diary card symptom code greater than 2, or requirement for other medications to control asthma, during prn screening period
  • Inability to perform 3 acceptable FVC maneuvers of which at least 2 reproducible FEV1s are within 10% of the largest FEV1
  • Inability to complete the methacholine challenge or methacholine PC20 FEV1 greater than 12.5 mg/ml
  • Evidence that patient or family may be unreliable or non-compliant or may move from the metropolitan area before trial completion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000575

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
CAMP Steering Committee
Investigators
Principal Investigator: N. F. Adkinson, MD Johns Hopkins University
Principal Investigator: Anne Fuhlbrigge, MD, MS Brigham and Women's Hospital
Principal Investigator: H. W. Kelly, PharmD University of New Mexico
Principal Investigator: Padmaja Subbarao, MD, MSc The Hospital for Sick Children
Principal Investigator: Paul Williams, MD Asthma, Inc.
Principal Investigator: Robert Strunk, MD Washington University
Principal Investigator: Stanley Szefler, MD National Jewish Health
Principal Investigator: James Tonascia, PhD Johns Hopkins University
Principal Investigator: Robert Zeiger, MD, PhD University of California, San Diego
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Tonascia, Principal Investigator, CAMP Data Coordinating Center, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000575     History of Changes
Other Study ID Numbers: 213, 5U01HL075417
Study First Received: October 27, 1999
Results First Received: October 16, 2013
Last Updated: February 20, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Nedocromil
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on April 16, 2014