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Childhood Asthma Management Program (CAMP) Phases I and II

This study is ongoing, but not recruiting participants.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000575
  Purpose

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: inhaled corticosteroids
Drug: nedocromil
Phase III

MedlinePlus related topics:   Asthma   

ChemIDplus related topics:   Corticosteroids    Nedocromil   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:   September 1991
Estimated Study Completion Date:   June 2007

Show detailed description  Show Detailed Description

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

Criteria

Asthmatic boys and girls, ages 5 to 12 at baseline.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000575

Sponsors and Collaborators

Investigators
Investigator:     N. Adkinson     Johns Hopkins University    
Investigator:     Anne Fuhlbrigge     Brigham and Women's Hospital    
Investigator:     H. Kelly     University of New Mexico    
Investigator:     Ian Maclusky     The Hospital for Sick Children    
Investigator:     Gail Shapiro     Asthma, Inc.    
Investigator:     Robert Strunk     Washington University School of Medicine    
Investigator:     Stanley Szefler     National Jewish Medical and Research Center    
Investigator:     James Tonascia     Johns Hopkins University    
Investigator:     James Tonascia     Johns Hopkins University    
Investigator:     Robert Zeiger     University of California, San Diego    
  More Information

Publications:
[No authors listed] 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.
 
[No authors listed] 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.
 
[No authors listed] 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, Ikle 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. No abstract available.
 
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.
 
[No authors listed] 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. 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. 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. Progression of Asthma Measured by Lung Function in the Childhood Asthma Management Program. Am J Respir Crit Care Med. 2004 Mar 17 [Epub ahead of print]
 
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 05.
 
Lazarus R, Raby BA, Lange C, Silverman EK, Kwiatkowski DJ, Vercelli D, Klimecki WJ, Martinez FD, Weiss ST. Toll-like Receptor 10 (TLR10) Genetic Variation is Associated with Asthma in Two Independent Samples. Am J Respir Crit Care Med. 2004 Jun 16 [Epub ahead of print]
 
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. Neuropsychol Dev Cogn C Child Neuropsychol. 2005 Aug;11(4):333-48.
 
Raby BA, Hwang ES, Steen KV, 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, Celedon JC, Litonjua AA, Lange C, Weiss ST. 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.
 

Study ID Numbers:   213
First Received:   October 27, 1999
Last Updated:   January 3, 2006
ClinicalTrials.gov Identifier:   NCT00000575
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Nedocromil
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 08, 2008




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