Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)
Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Lung Diseases
Intervention: Placebo (Drug); Nedocromil (Drug); Budesonide (Drug)
Phase: Phase 3
Sponsored by: Johns Hopkins Bloomberg School of Public Health
Official(s) and/or principal investigator(s):
N. F. Adkinson, MD, Principal Investigator, Affiliation: Johns Hopkins University
Anne Fuhlbrigge, MD, MS, Principal Investigator, Affiliation: Brigham and Women's Hospital
H. W. Kelly, PharmD, Principal Investigator, Affiliation: University of New Mexico
Padmaja Subbarao, MD, MSc, Principal Investigator, Affiliation: The Hospital for Sick Children
Paul Williams, MD, Principal Investigator, Affiliation: Asthma, Inc.
Robert Strunk, MD, Principal Investigator, Affiliation: Washington University School of Medicine
Stanley Szefler, MD, Principal Investigator, Affiliation: National Jewish Health
James Tonascia, PhD, Principal Investigator, Affiliation: Johns Hopkins University
Robert Zeiger, MD, PhD, Principal Investigator, Affiliation: University of California, San Diego
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.
Official title: Childhood Asthma Management Program
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period
Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs
Change From Baseline in the Rate of Asthma Free Days
Need for Urgent Care for Asthma
Change in Height From Baseline to End of Treatment, 4-6 Years Later
Standardized Depression Scale -- Children's Depression Inventory
Asthma is a serious chronic condition, affecting approximately 14 million Americans. People
with asthma experience well over 100 million days of restricted activity annually, and costs
for asthma care exceed $10 billion a year. Asthma is much more prevalent among children
Hospitalizations for asthma have been increasing among children. For example, from 1979 to
1987, the hospital discharge rate with asthma as the first-listed diagnosis rose 43 percent
among children less than 15 years of age, from 19. 8 to 28. 4 discharges per 10,000
Death rates for asthma are greater in Blacks than in whites, and the difference is
increasing. In 1979, Blacks of both sexes were about twice as likely to die from asthma as
whites. Over the past decade this ratio has increased, and by 1987 the asthma death rate
was almost three times greater among Blacks than whites. In children, these mortality
differences between Blacks and whites are even more striking.
Current knowledge about the epidemiology and natural history of childhood asthma is
incomplete, but the relationship between asthma early in life and development of chronic
obstructive pulmonary disease (COPD) in adulthood is becoming more apparent. Asthmatic
children with persistent and severe asthma symptoms have lower levels of lung function by
young adulthood than those with milder disease. Recent longitudinal studies have confirmed
a decrease in rate of growth of lung function as measured by FEV1 among symptomatic
(primarily wheeze) children compared to asymptomatic children. Among persons who develop
COPD, initial level of lung function is the strongest predictor of subsequent rapid decline
of ventilatory function.
Thus, less than maximally attained levels of lung function among children with asthma may
predispose them to greater than normal decline of lung function later in life. Although the
long-term effect of treatment on the course of asthma is not known, the treatment goal of
decreasing bronchial hyperresponsiveness and maximizing lung function and growth during
childhood may have a beneficial effect on lung health throughout life and prevent
progression to irreversible airflow obstruction.
Two classes of medications are currently available for treatment of
inflammation--corticosteroids and cromolyn sodium. Inhaled corticosteroids have
significantly fewer side effects than systemic administration. Corticosteroids do not
inhibit the early asthmatic response, but are effective in suppressing the inflammation and
bronchial hyperresponsiveness of the late phase response. Long-term studies of inhaled
corticosteroids have shown beneficial effects on lung function as measured by FEV1.
However, there has been concern about possible effects of long-term use of inhaled
corticosteroids. Although epidemiological studies of the use of inhaled corticosteroids
have shown no significant adverse effects, large-scale randomized controlled studies of
their effects on children's growth and development are needed.
When CAMP was initiated in the United States, bronchodilator treatment was the most common
approach to therapy. Two classes of bronchodilators, inhaled beta-2-adrenergic agonists and
oral theophylline, are most frequently prescribed for asthma. To date, no randomized,
controlled studies have compared the two classes of anti-inflammatory medications to each
other and to bronchodilator therapy on the course of asthma.
The initiative was proposed by the Pulmonary Disease Advisory Committee working group in
October 1987 and approved by the full committee at the February 1988 meeting and by the
National Heart, Lung, and Blood Advisory Council in May 1990. The Request for Proposals was
released in October 1990. Awards were made in September 1991.
Children were randomized to one of three treatment groups to receive either: inhaled
albuterol alone, albuterol with inhaled budesonide, albuterol with nedocromil. Upon
randomization, data were collected on demographic factors, physical and psychosocial
development, clinical factors including medical history and extent of allergies, and quality
of life factors including limitation of activity, absenteeism from school, emergency room
visits, and hospitalizations. All subjects received a common educational program, differing
only in the information presented regarding the medication used by the subjects. Each
subject was given a standard protocol for dealing with asthma attacks. All subjects were
treated and followed for five years with quarterly visits yearly. Recruitment began in July
1993 and ended in June 1995 with the accrual of 1,041 subjects.
The study has been extended through June 2011 through three funding phases to observe the
subjects but not provide asthma treatment. This will allow CAMP to (1.) determine the full
impact of 4 to 6 years of anti-inflammatory therapy on attaining maximal lung function and
final height; (2.) examine the natural history of asthma through age 26; and (3.) define
patterns of reduced lung function growth and early decline of lung function in young adults.
Minimum age: 5 Years.
Maximum age: 12 Years.
- 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
- 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)
- 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
Locations and Contacts
Design and implementation of a patient education center for the Childhood Asthma Management Program. Childhood Asthma Management Program Research Group. Ann Allergy Asthma Immunol. 1998 Dec;81(6):571-81.
Recruitment of participants in the childhood Asthma Management Program (CAMP). I. Description of methods: Childhood Asthma Management Program Research Group. J Asthma. 1999 May;36(3):217-37.
The Childhood Asthma Management Program (CAMP): design, rationale, and methods. Childhood Asthma Management Program Research Group. Control Clin Trials. 1999 Feb;20(1):91-120.
Zeiger RS, Dawson C, Weiss S. Relationships between duration of asthma and asthma severity among children in the Childhood Asthma Management Program (CAMP). J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):376-87.
Nelson HS, Szefler SJ, Jacobs J, Huss K, Shapiro G, Sternberg AL. The relationships among environmental allergen sensitization, allergen exposure, pulmonary function, and bronchial hyperresponsiveness in the Childhood Asthma Management Program. J Allergy Clin Immunol. 1999 Oct;104(4 Pt 1):775-85.
Bender BG, Annett RD, Iklé D, DuHamel TR, Rand C, Strunk RC. Relationship between disease and psychological adaptation in children in the Childhood Asthma Management Program and their families. CAMP Research Group. Arch Pediatr Adolesc Med. 2000 Jul;154(7):706-13.
Larsen GL. Focusing on childhood asthma: the childhood asthma management program (CAMP). J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):371-3.
Weiss ST, Van Natta ML, Zeiger RS. Relationship between increased airway responsiveness and asthma severity in the childhood asthma management program. Am J Respir Crit Care Med. 2000 Jul;162(1):50-6.
Annett RD, Aylward EH, Lapidus J, Bender BG, DuHamel T. Neurocognitive functioning in children with mild and moderate asthma in the childhood asthma management program. The Childhood Asthma Management Program (CAMP) Research Group. J Allergy Clin Immunol. 2000 Apr;105(4):717-24.
Long-term effects of budesonide or nedocromil in children with asthma. The Childhood Asthma Management Program Research Group. N Engl J Med. 2000 Oct 12;343(15):1054-63.
Huss K, Adkinson NF Jr, Eggleston PA, Dawson C, Van Natta ML, Hamilton RG. House dust mite and cockroach exposure are strong risk factors for positive allergy skin test responses in the Childhood Asthma Management Program. J Allergy Clin Immunol. 2001 Jan;107(1):48-54.
Yu O, Sheppard L, Lumley T, Koenig JQ, Shapiro GG. Effects of ambient air pollution on symptoms of asthma in Seattle-area children enrolled in the CAMP study. Environ Health Perspect. 2000 Dec;108(12):1209-14.
Annett RD, Bender BG, Lapidus J, Duhamel TR, Lincoln A. Predicting children's quality of life in an asthma clinical trial: what do children's reports tell us? J Pediatr. 2001 Dec;139(6):854-61.
Weiss ST, Horner A, Shapiro G, Sternberg AL; Childhood Asthma Management Program (CAMP) Research Group. The prevalence of environmental exposure to perceived asthma triggers in children with mild-to-moderate asthma: data from the Childhood Asthma Management Program (CAMP). J Allergy Clin Immunol. 2001 Apr;107(4):634-40.
Strunk RC, Sternberg AL, Bacharier LB, Szefler SJ. Nocturnal awakening caused by asthma in children with mild-to-moderate asthma in the childhood asthma management program. J Allergy Clin Immunol. 2002 Sep;110(3):395-403.
DeMeo DL, Lange C, Silverman EK, Senter JM, Drazen JM, Barth MJ, Laird N, Weiss ST. Univariate and multivariate family-based association analysis of the IL-13 ARG130GLN polymorphism in the Childhood Asthma Management Program. Genet Epidemiol. 2002 Nov;23(4):335-48.
Strunk RC, Bender B, Young DA, Sagel S, Glynn E, Caesar M, Lawhon C. Predictors of protocol adherence in a pediatric asthma clinical trial. J Allergy Clin Immunol. 2002 Oct;110(4):596-602.
Kelly HW, Strunk RC, Donithan M, Bloomberg GR, McWilliams BC, Szefler S; Childhood Asthma Management Program (CAMP). Growth and bone density in children with mild-moderate asthma: a cross-sectional study in children entering the Childhood Asthma Management Program (CAMP). J Pediatr. 2003 Mar;142(3):286-91.
Bacharier LB, Dawson C, Bloomberg GR, Bender B, Wilson L, Strunk RC; Childhood Asthma Management Program Research Group. Hospitalization for asthma: atopic, pulmonary function, and psychological correlates among participants in the Childhood Asthma Management Program. Pediatrics. 2003 Aug;112(2):e85-92.
Tantisira KG, Litonjua AA, Weiss ST, Fuhlbrigge AL; Childhood Asthma Management Program Research Group. Association of body mass with pulmonary function in the Childhood Asthma Management Program (CAMP). Thorax. 2003 Dec;58(12):1036-41.
Silverman EK, Kwiatkowski DJ, Sylvia JS, Lazarus R, Drazen JM, Lange C, Laird NM, Weiss ST. Family-based association analysis of beta2-adrenergic receptor polymorphisms in the childhood asthma management program. J Allergy Clin Immunol. 2003 Nov;112(5):870-6.
Lange C, Lyon H, DeMeo D, Raby B, Silverman EK, Weiss ST. A new powerful non-parametric two-stage approach for testing multiple phenotypes in family-based association studies. Hum Hered. 2003;56(1-3):10-7.
Slaughter JC, Lumley T, Sheppard L, Koenig JQ, Shapiro GG. Effects of ambient air pollution on symptom severity and medication use in children with asthma. Ann Allergy Asthma Immunol. 2003 Oct;91(4):346-53.
Bender BG, Ellison MC, Gleason M, Murphy JR, Sundstrom DA, Szefler SJ. Minimizing attrition in a long-term clinical trial of pediatric asthma. Ann Allergy Asthma Immunol. 2003 Aug;91(2):168-76.
Raby BA, Silverman EK, Lazarus R, Lange C, Kwiatkowski DJ, Weiss ST. Chromosome 12q harbors multiple genetic loci related to asthma and asthma-related phenotypes. Hum Mol Genet. 2003 Aug 15;12(16):1973-9.
Lake SL, Lyon H, Tantisira K, Silverman EK, Weiss ST, Laird NM, Schaid DJ. Estimation and tests of haplotype-environment interaction when linkage phase is ambiguous. Hum Hered. 2003;55(1):56-65.
Bacharier LB, Raissy HH, Wilson L, McWilliams B, Strunk RC, Kelly HW. Long-term effect of budesonide on hypothalamic-pituitary-adrenal axis function in children with mild to moderate asthma. Pediatrics. 2004 Jun;113(6):1693-9.
Covar RA, Spahn JD, Murphy JR, Szefler SJ; Childhood Asthma Management Program Research Group. Progression of asthma measured by lung function in the childhood asthma management program. Am J Respir Crit Care Med. 2004 Aug 1;170(3):234-41. Epub 2004 Mar 17.
Tantisira KG, Lake S, Silverman ES, Palmer LJ, Lazarus R, Silverman EK, Liggett SB, Gelfand EW, Rosenwasser LJ, Richter B, Israel E, Wechsler M, Gabriel S, Altshuler D, Lander E, Drazen J, Weiss ST. Corticosteroid pharmacogenetics: association of sequence variants in CRHR1 with improved lung function in asthmatics treated with inhaled corticosteroids. Hum Mol Genet. 2004 Jul 1;13(13):1353-9. Epub 2004 May 5.
Lazarus R, Raby BA, Lange C, Silverman EK, Kwiatkowski DJ, Vercelli D, Klimecki WJ, Martinez FD, Weiss ST. TOLL-like receptor 10 genetic variation is associated with asthma in two independent samples. Am J Respir Crit Care Med. 2004 Sep 15;170(6):594-600. Epub 2004 Jun 16.
Covar RA, Szefler SJ, Martin RJ, Sundstrom DA, Silkoff PE, Murphy J, Young DA, Spahn JD. Relations between exhaled nitric oxide and measures of disease activity among children with mild-to-moderate asthma. J Pediatr. 2003 May;142(5):469-75.
Covar RA, Spahn JD, Martin RJ, Silkoff PE, Sundstrom DA, Murphy J, Szefler SJ. Safety and application of induced sputum analysis in childhood asthma. J Allergy Clin Immunol. 2004 Sep;114(3):575-82.
Randolph AG, Lange C, Silverman EK, Lazarus R, Silverman ES, Raby B, Brown A, Ozonoff A, Richter B, Weiss ST. The IL12B gene is associated with asthma. Am J Hum Genet. 2004 Oct;75(4):709-15. Epub 2004 Aug 20.
Randolph AG, Lange C, Silverman EK, Lazarus R, Weiss ST. Extended haplotype in the tumor necrosis factor gene cluster is associated with asthma and asthma-related phenotypes. Am J Respir Crit Care Med. 2005 Sep 15;172(6):687-92. Epub 2005 Jun 23.
Annett RD, Stansbury K, Kelly HW, Strunk RC. Association of hypothalamic-pituitary-adrenal axis function with neuropsychological performance in children with mild/moderate asthma. Child Neuropsychol. 2005 Aug;11(4):333-48.
Raby BA, Hwang ES, Van Steen K, Tantisira K, Peng S, Litonjua A, Lazarus R, Giallourakis C, Rioux JD, Sparrow D, Silverman EK, Glimcher LH, Weiss ST. T-bet polymorphisms are associated with asthma and airway hyperresponsiveness. Am J Respir Crit Care Med. 2006 Jan 1;173(1):64-70. Epub 2005 Sep 22.
Raby BA, Van Steen K, Celedón JC, Litonjua AA, Lange C, Weiss ST; CAMP Research Group. Paternal history of asthma and airway responsiveness in children with asthma. Am J Respir Crit Care Med. 2005 Sep 1;172(5):552-8. Epub 2005 Jun 3.
Starting date: September 1991
Last updated: February 20, 2014