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

NCT00000575 | Completed Phase 3 Results DMC

• 2 other identifiers: 2135U01HL075417
• Study Type: interventional
• Target: 1,041
• Locations: 0 countries
• Sites: N/A

Brief 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

Asthma; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period

  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.

  At the end of treatment, 4-6 years from baseline assessment

Secondary Outcomes (6)

• Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs

  4-6 years from baseline

• Change From Baseline in the Rate of Asthma Free Days

  4-6 years from baseline

• Need for Urgent Care for Asthma

  4-6 years from baseline

• Mortality

  4-6 years from baseline

• Change in Height From Baseline to End of Treatment, 4-6 Years Later

  4-6 years from baseline

Study Arms (3)

1 Budesonide

ACTIVE COMPARATOR

Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn

Drug: Budesonide

2 Nedocromil

ACTIVE COMPARATOR

Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn

Drug: Nedocromil

3 Placebo

PLACEBO COMPARATOR

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

Interventions

Placebo DRUG

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.

3 Placebo

Nedocromil DRUG

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

Also known as: Tilade

2 Nedocromil

Budesonide DRUG

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

Also known as: Pulmicort

1 Budesonide

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• CAMP Steering Committee: collaborator

Related Publications (50)

• 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.

  PMID: 9892029 BACKGROUND

• 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.

  PMID: 10350219 BACKGROUND

• 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.

  PMID: 10027502 BACKGROUND

• 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. doi: 10.1016/s0091-6749(99)70460-4.

  PMID: 10069869 BACKGROUND

• 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. doi: 10.1016/s0091-6749(99)70287-3.

  PMID: 10518821 BACKGROUND

• 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. doi: 10.1001/archpedi.154.7.706.

  PMID: 10891023 BACKGROUND

• Larsen GL. Focusing on childhood asthma: the childhood asthma management program (CAMP). J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):371-3. doi: 10.1016/s0091-6749(99)70458-6. No abstract available.

  PMID: 10069867 BACKGROUND

• 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. doi: 10.1164/ajrccm.162.1.9811005.

  PMID: 10903219 BACKGROUND

• 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. doi: 10.1067/mai.2000.105226.

  PMID: 10756221 BACKGROUND

• Childhood Asthma Management Program Research Group; Szefler S, Weiss S, Tonascia J, Adkinson NF, Bender B, Cherniack R, Donithan M, Kelly HW, Reisman J, Shapiro GG, Sternberg AL, Strunk R, Taggart V, Van Natta M, Wise R, Wu M, Zeiger R. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000 Oct 12;343(15):1054-63. doi: 10.1056/NEJM200010123431501.

  PMID: 11027739 BACKGROUND

• 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. doi: 10.1067/mai.2001.111146.

  PMID: 11149990 BACKGROUND

• 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. doi: 10.1289/ehp.001081209.

  PMID: 11133403 BACKGROUND

• 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. doi: 10.1067/mpd.2001.119444.

  PMID: 11743513 BACKGROUND

• 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. doi: 10.1067/mai.2001.113869.

  PMID: 11295651 BACKGROUND

• 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. doi: 10.1067/mai.2002.127433.

  PMID: 12209085 BACKGROUND

• 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. doi: 10.1002/gepi.10182.

  PMID: 12432502 BACKGROUND

• 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. doi: 10.1067/mai.2002.128803.

  PMID: 12373267 BACKGROUND

• 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. doi: 10.1067/mpd.2003.86.

  PMID: 12640377 BACKGROUND

• 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. doi: 10.1542/peds.112.2.e85.

  PMID: 12897312 BACKGROUND

• 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. doi: 10.1136/thorax.58.12.1036.

  PMID: 14645968 BACKGROUND

• 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. doi: 10.1016/s0091-6749(03)02023-2.

  PMID: 14610472 BACKGROUND

• 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. doi: 10.1159/000073728.

  PMID: 14614234 BACKGROUND

• 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. doi: 10.1016/S1081-1206(10)61681-X.

  PMID: 14582813 BACKGROUND

• 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. doi: 10.1016/S1081-1206(10)62173-4.

  PMID: 12952111 BACKGROUND

• 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. doi: 10.1093/hmg/ddg208.

  PMID: 12913068 BACKGROUND

• 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. doi: 10.1159/000071811.

  PMID: 12890927 BACKGROUND

• 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. doi: 10.1542/peds.113.6.1693.

  PMID: 15173493 BACKGROUND

• 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. doi: 10.1164/rccm.200308-1174OC. Epub 2004 Mar 17.

  PMID: 15028558 BACKGROUND

• 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. doi: 10.1093/hmg/ddh149. Epub 2004 May 5.

  PMID: 15128701 BACKGROUND

• 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. doi: 10.1164/rccm.200404-491OC. Epub 2004 Jun 16.

  PMID: 15201134 BACKGROUND

• 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. doi: 10.1067/mpd.2003.187.

  PMID: 12756375 BACKGROUND

• 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. doi: 10.1016/j.jaci.2004.06.036.

  PMID: 15356559 BACKGROUND

• 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. doi: 10.1086/424886. Epub 2004 Aug 20.

  PMID: 15322986 BACKGROUND

• 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. doi: 10.1164/rccm.200501-122OC. Epub 2005 Jun 23.

  PMID: 15976383 BACKGROUND

• 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. doi: 10.1080/09297040490916929.

  PMID: 16051562 BACKGROUND

• 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. doi: 10.1164/rccm.200503-505OC. Epub 2005 Sep 22.

  PMID: 16179640 BACKGROUND

• Raby BA, Van Steen K, Celedon 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. doi: 10.1164/rccm.200501-010OC. Epub 2005 Jun 3.

  PMID: 15937295 BACKGROUND

• Li J, Hong X, Jiang M, Kho AT, Tiwari A, Wang AL, Chase RP, Celedon JC, Weiss ST, McGeachie MJ, Tantisira KG. A novel piwi-interacting RNA associates with type 2-high asthma phenotypes. J Allergy Clin Immunol. 2024 Mar;153(3):695-704. doi: 10.1016/j.jaci.2023.10.032. Epub 2023 Dec 4.

  PMID: 38056635 DERIVED

• Sordillo JE, Lutz SM, Kelly RS, McGeachie MJ, Dahlin A, Tantisira K, Clish C, Lasky-Su J, Wu AC. Plasmalogens Mediate the Effect of Age on Bronchodilator Response in Individuals With Asthma. Front Med (Lausanne). 2020 Feb 14;7:38. doi: 10.3389/fmed.2020.00038. eCollection 2020.

  PMID: 32118022 DERIVED

• Wang AL, Gruzieva O, Qiu W, Kebede Merid S, Celedon JC, Raby BA, Soderhall C, DeMeo DL, Weiss ST, Melen E, Tantisira KG. DNA methylation is associated with inhaled corticosteroid response in persistent childhood asthmatics. Clin Exp Allergy. 2019 Sep;49(9):1225-1234. doi: 10.1111/cea.13447. Epub 2019 Aug 15.

  PMID: 31187518 DERIVED

• Sordillo JE, McGeachie M, Lutz SM, Lasky-Su J, Tantisira K, Tsai CH, Dahlin A, Kelly R, Wu AC. Longitudinal analysis of bronchodilator response in asthmatics and effect modification of age-related trends by genotype. Pediatr Pulmonol. 2019 Feb;54(2):158-164. doi: 10.1002/ppul.24219. Epub 2018 Dec 25.

  PMID: 30585438 DERIVED

• Kho AT, McGeachie MJ, Moore KG, Sylvia JM, Weiss ST, Tantisira KG. Circulating microRNAs and prediction of asthma exacerbation in childhood asthma. Respir Res. 2018 Jun 26;19(1):128. doi: 10.1186/s12931-018-0828-6.

  PMID: 29940952 DERIVED

• McGeachie MJ, Clemmer GL, Croteau-Chonka DC, Castaldi PJ, Cho MH, Sordillo JE, Lasky-Su JA, Raby BA, Tantisira KG, Weiss ST. Whole genome prediction and heritability of childhood asthma phenotypes. Immun Inflamm Dis. 2016 Nov 28;4(4):487-496. doi: 10.1002/iid3.133. eCollection 2016 Dec.

  PMID: 27980782 DERIVED

• McGeachie MJ, Yates KP, Zhou X, Guo F, Sternberg AL, Van Natta ML, Wise RA, Szefler SJ, Sharma S, Kho AT, Cho MH, Croteau-Chonka DC, Castaldi PJ, Jain G, Sanyal A, Zhan Y, Lajoie BR, Dekker J, Stamatoyannopoulos J, Covar RA, Zeiger RS, Adkinson NF, Williams PV, Kelly HW, Grasemann H, Vonk JM, Koppelman GH, Postma DS, Raby BA, Houston I, Lu Q, Fuhlbrigge AL, Tantisira KG, Silverman EK, Tonascia J, Strunk RC, Weiss ST; CAMP Research Group. Genetics and Genomics of Longitudinal Lung Function Patterns in Individuals with Asthma. Am J Respir Crit Care Med. 2016 Dec 15;194(12):1465-1474. doi: 10.1164/rccm.201602-0250OC.

  PMID: 27367781 DERIVED

• McGeachie MJ, Yates KP, Zhou X, Guo F, Sternberg AL, Van Natta ML, Wise RA, Szefler SJ, Sharma S, Kho AT, Cho MH, Croteau-Chonka DC, Castaldi PJ, Jain G, Sanyal A, Zhan Y, Lajoie BR, Dekker J, Stamatoyannopoulos J, Covar RA, Zeiger RS, Adkinson NF, Williams PV, Kelly HW, Grasemann H, Vonk JM, Koppelman GH, Postma DS, Raby BA, Houston I, Lu Q, Fuhlbrigge AL, Tantisira KG, Silverman EK, Tonascia J, Weiss ST, Strunk RC. Patterns of Growth and Decline in Lung Function in Persistent Childhood Asthma. N Engl J Med. 2016 May 12;374(19):1842-1852. doi: 10.1056/NEJMoa1513737.

  PMID: 27168434 DERIVED

• Strunk RC, Colvin R, Bacharier LB, Fuhlbrigge A, Forno E, Arbelaez AM, Tantisira KG; Childhood Asthma Management Program Research Group. Airway Obstruction Worsens in Young Adults with Asthma Who Become Obese. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):765-71.e2. doi: 10.1016/j.jaip.2015.05.009. Epub 2015 Jul 9.

  PMID: 26164807 DERIVED

• Drye LT, Casper AS, Sternberg AL, Holbrook JT, Jenkins G, Meinert CL. The transitioning from trials to extended follow-up studies. Clin Trials. 2014 Dec;11(6):635-47. doi: 10.1177/1740774514547396. Epub 2014 Aug 12.

  PMID: 25115882 DERIVED

• Kelly HW, Sternberg AL, Lescher R, Fuhlbrigge AL, Williams P, Zeiger RS, Raissy HH, Van Natta ML, Tonascia J, Strunk RC; CAMP Research Group. Effect of inhaled glucocorticoids in childhood on adult height. N Engl J Med. 2012 Sep 6;367(10):904-12. doi: 10.1056/NEJMoa1203229. Epub 2012 Sep 3.

  PMID: 22938716 DERIVED

• Tantisira KG, Lasky-Su J, Harada M, Murphy A, Litonjua AA, Himes BE, Lange C, Lazarus R, Sylvia J, Klanderman B, Duan QL, Qiu W, Hirota T, Martinez FD, Mauger D, Sorkness C, Szefler S, Lazarus SC, Lemanske RF Jr, Peters SP, Lima JJ, Nakamura Y, Tamari M, Weiss ST. Genomewide association between GLCCI1 and response to glucocorticoid therapy in asthma. N Engl J Med. 2011 Sep 29;365(13):1173-83. doi: 10.1056/NEJMoa0911353. Epub 2011 Sep 26.

  PMID: 21991891 DERIVED

• Hunninghake GM, Cho MH, Tesfaigzi Y, Soto-Quiros ME, Avila L, Lasky-Su J, Stidley C, Melen E, Soderhall C, Hallberg J, Kull I, Kere J, Svartengren M, Pershagen G, Wickman M, Lange C, Demeo DL, Hersh CP, Klanderman BJ, Raby BA, Sparrow D, Shapiro SD, Silverman EK, Litonjua AA, Weiss ST, Celedon JC. MMP12, lung function, and COPD in high-risk populations. N Engl J Med. 2009 Dec 31;361(27):2599-608. doi: 10.1056/NEJMoa0904006. Epub 2009 Dec 16.

  PMID: 20018959 DERIVED

MeSH Terms

Conditions

Asthma; Lung Diseases

Interventions

Nedocromil; Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Alice Sternberg
• Organization: Johns Hopkins Bloomberg School of Public Health, Dept of Epidemiology

asternbe@jhsph.edu

410-955-3752

Study Officials

• 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 School of Medicine

  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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, CAMP Data Coordinating Center

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: September 1, 1991
• Primary Completion: October 1, 1999
• Study Completion: March 1, 2012
• Last Updated: April 3, 2014
• Results First Posted: April 3, 2014

Record last verified: 2014-02