Nctid:
NCT00000575
Payload:
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"relevance"=>"LOW"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M14967", "name"=>"Respiratory Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10020", "name"=>"Hypersensitivity, Immediate", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D017835", "term"=>"Nedocromil"}, {"id"=>"D019819", "term"=>"Budesonide"}], "ancestors"=>[{"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D001993", "term"=>"Bronchodilator Agents"}, {"id"=>"D001337", "term"=>"Autonomic Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018927", "term"=>"Anti-Asthmatic Agents"}, {"id"=>"D019141", "term"=>"Respiratory System Agents"}, {"id"=>"D005938", "term"=>"Glucocorticoids"}, {"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000082142", "term"=>"Mast Cell Stabilizers"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D018926", "term"=>"Anti-Allergic Agents"}], "browseLeaves"=>[{"id"=>"M21711", "name"=>"Budesonide", "asFound"=>"Less", "relevance"=>"HIGH"}, {"id"=>"M3767", "name"=>"Albuterol", "relevance"=>"LOW"}, {"id"=>"M20024", "name"=>"Nedocromil", "asFound"=>"Sufenta", "relevance"=>"HIGH"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M5269", "name"=>"Bronchodilator Agents", "relevance"=>"LOW"}, {"id"=>"M20963", "name"=>"Anti-Asthmatic Agents", "relevance"=>"LOW"}, {"id"=>"M21137", "name"=>"Respiratory System Agents", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", 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disorders", "assessmentType"=>"NON_SYSTEMATIC_ASSESSMENT"}, {"term"=>"Musculoskeletal (low bone mineral density, back pain)", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>311, "numEvents"=>0, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>312, "numEvents"=>1, "numAffected"=>1}, {"groupId"=>"EG002", "numAtRisk"=>418, "numEvents"=>1, "numAffected"=>1}], "organSystem"=>"Musculoskeletal and connective tissue disorders", "assessmentType"=>"NON_SYSTEMATIC_ASSESSMENT"}, {"term"=>"Phsychiatric (behavior)", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>311, "numEvents"=>1, "numAffected"=>1}, {"groupId"=>"EG001", "numAtRisk"=>312, "numEvents"=>1, "numAffected"=>1}, {"groupId"=>"EG002", "numAtRisk"=>418, "numEvents"=>0, "numAffected"=>0}], "organSystem"=>"Psychiatric disorders", "assessmentType"=>"NON_SYSTEMATIC_ASSESSMENT"}, {"term"=>"Respiratory (cough, wheeze, chest tightness, croup)", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>311, "numEvents"=>0, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>312, "numEvents"=>5, "numAffected"=>5}, {"groupId"=>"EG002", "numAtRisk"=>418, "numEvents"=>1, "numAffected"=>1}], "organSystem"=>"Respiratory, thoracic and mediastinal disorders", "assessmentType"=>"NON_SYSTEMATIC_ASSESSMENT"}], "seriousEvents"=>[{"term"=>"Asthma exacerbation", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>311, "numEvents"=>0, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>312, "numEvents"=>1, "numAffected"=>1}, {"groupId"=>"EG002", "numAtRisk"=>418, "numEvents"=>1, "numAffected"=>1}], "organSystem"=>"Respiratory, thoracic and mediastinal disorders", "assessmentType"=>"NON_SYSTEMATIC_ASSESSMENT"}, {"term"=>"Psychiatric (hallucinations)", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>311, "numEvents"=>0, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>312, "numEvents"=>0, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>418, "numEvents"=>2, "numAffected"=>2}], "organSystem"=>"Psychiatric disorders", "assessmentType"=>"NON_SYSTEMATIC_ASSESSMENT"}, {"term"=>"Renal stone", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>311, "numEvents"=>0, "numAffected"=>0}, {"groupId"=>"EG001", "numAtRisk"=>312, "numEvents"=>0, "numAffected"=>0}, {"groupId"=>"EG002", "numAtRisk"=>418, "numEvents"=>1, "numAffected"=>1}], "organSystem"=>"Renal and urinary disorders", "assessmentType"=>"NON_SYSTEMATIC_ASSESSMENT"}], "frequencyThreshold"=>"0"}, "outcomeMeasuresModule"=>{"outcomeMeasures"=>[{"type"=>"PRIMARY", "title"=>"Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"306", "groupId"=>"OG000"}, {"value"=>"307", "groupId"=>"OG001"}, {"value"=>"411", "groupId"=>"OG002"}]}], "groups"=>[{"id"=>"OG000", "title"=>"1 Budesonide", "description"=>"Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn"}, {"id"=>"OG001", "title"=>"2 Nedocromil", "description"=>"Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn"}, {"id"=>"OG002", "title"=>"3 Placebo", "description"=>"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."}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"0.6", "spread"=>"9.6", "groupId"=>"OG000"}, {"value"=>"-0.5", "spread"=>"9.6", "groupId"=>"OG001"}, {"value"=>"-0.1", "spread"=>"9.6", "groupId"=>"OG002"}]}]}], "paramType"=>"MEAN", "timeFrame"=>"At the end of treatment, 4-6 years from baseline assessment", "description"=>"Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). 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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.", "unitOfMeasure"=>"cm", "dispersionType"=>"Standard Deviation", "reportingStatus"=>"POSTED"}, {"type"=>"SECONDARY", "title"=>"Standardized Depression Scale -- Children's Depression Inventory", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"311", "groupId"=>"OG000"}, {"value"=>"312", "groupId"=>"OG001"}, {"value"=>"418", "groupId"=>"OG002"}]}], "groups"=>[{"id"=>"OG000", "title"=>"1 Budesonide", "description"=>"Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn"}, {"id"=>"OG001", "title"=>"2 Nedocromil", "description"=>"Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn"}, {"id"=>"OG002", "title"=>"3 Placebo", "description"=>"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."}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"-3.2", "spread"=>"5.1", "groupId"=>"OG000"}, {"value"=>"-1.8", "spread"=>"5.1", "groupId"=>"OG001"}, {"value"=>"-2.2", "spread"=>"5.1", "groupId"=>"OG002"}]}]}], "paramType"=>"MEAN", "timeFrame"=>"4-6 years from baseline", "description"=>"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.", "unitOfMeasure"=>"units on a scale", "dispersionType"=>"Standard Deviation", "reportingStatus"=>"POSTED"}]}, "participantFlowModule"=>{"groups"=>[{"id"=>"FG000", "title"=>"1 Budesonide", "description"=>"Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn"}, {"id"=>"FG001", "title"=>"2 Nedocromil", "description"=>"Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn"}, {"id"=>"FG002", "title"=>"3 Placebo", "description"=>"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."}], "periods"=>[{"title"=>"Overall Study", "milestones"=>[{"type"=>"STARTED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"311"}, {"groupId"=>"FG001", "numSubjects"=>"312"}, {"groupId"=>"FG002", "numSubjects"=>"418"}]}, {"type"=>"COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"311"}, {"groupId"=>"FG001", "numSubjects"=>"312"}, {"groupId"=>"FG002", "numSubjects"=>"418"}]}, {"type"=>"NOT COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"0"}, {"groupId"=>"FG001", "numSubjects"=>"0"}, {"groupId"=>"FG002", "numSubjects"=>"0"}]}]}], "recruitmentDetails"=>"Between December 1993 and September 1995, 1041 children from 5 through 12 years of age with mild to moderate asthma at eight clinical centers (two HMOs associated with academic or research institutions and six located in specialty practices within academic or research institutions) were enrolled.", "preAssignmentDetails"=>"Patients were required to stop all asthma medications except as needed albuterol (prednisone could be used for asthma exacerbations) at the close of the second screening visit. Also at this time, patients began keeping a daily diary of asthma signs and symptoms, medications, school absences, and physician contacts."}, "baselineCharacteristicsModule"=>{"denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"311", "groupId"=>"BG000"}, {"value"=>"312", "groupId"=>"BG001"}, {"value"=>"418", "groupId"=>"BG002"}, {"value"=>"1041", "groupId"=>"BG003"}]}], "groups"=>[{"id"=>"BG000", "title"=>"1 Budesonide", "description"=>"Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn"}, {"id"=>"BG001", "title"=>"2 Nedocromil", "description"=>"Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn"}, {"id"=>"BG002", "title"=>"3 Placebo", "description"=>"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."}, {"id"=>"BG003", "title"=>"Total", "description"=>"Total of all reporting groups"}], "measures"=>[{"title"=>"Age, Categorical", "classes"=>[{"categories"=>[{"title"=>"<=18 years", "measurements"=>[{"value"=>"311", "groupId"=>"BG000"}, {"value"=>"312", "groupId"=>"BG001"}, {"value"=>"418", "groupId"=>"BG002"}, {"value"=>"1041", "groupId"=>"BG003"}]}, {"title"=>"Between 18 and 65 years", "measurements"=>[{"value"=>"0", "groupId"=>"BG000"}, {"value"=>"0", "groupId"=>"BG001"}, {"value"=>"0", "groupId"=>"BG002"}, {"value"=>"0", "groupId"=>"BG003"}]}, {"title"=>">=65 years", "measurements"=>[{"value"=>"0", "groupId"=>"BG000"}, {"value"=>"0", "groupId"=>"BG001"}, {"value"=>"0", "groupId"=>"BG002"}, {"value"=>"0", "groupId"=>"BG003"}]}]}], "paramType"=>"COUNT_OF_PARTICIPANTS", "unitOfMeasure"=>"Participants"}, {"title"=>"Age, Continuous", "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"9.0", "spread"=>"2.1", "groupId"=>"BG000"}, {"value"=>"8.8", "spread"=>"2.1", "groupId"=>"BG001"}, {"value"=>"9.0", "spread"=>"2.2", "groupId"=>"BG002"}, {"value"=>"8.9", "spread"=>"2.1", "groupId"=>"BG003"}]}]}], "paramType"=>"MEAN", "unitOfMeasure"=>"years", "dispersionType"=>"STANDARD_DEVIATION"}, {"title"=>"Sex: Female, Male", "classes"=>[{"categories"=>[{"title"=>"Female", "measurements"=>[{"value"=>"130", "groupId"=>"BG000"}, {"value"=>"106", "groupId"=>"BG001"}, {"value"=>"184", "groupId"=>"BG002"}, {"value"=>"420", "groupId"=>"BG003"}]}, {"title"=>"Male", "measurements"=>[{"value"=>"181", "groupId"=>"BG000"}, {"value"=>"206", "groupId"=>"BG001"}, {"value"=>"234", "groupId"=>"BG002"}, {"value"=>"621", "groupId"=>"BG003"}]}]}], "paramType"=>"COUNT_OF_PARTICIPANTS", "unitOfMeasure"=>"Participants"}, {"title"=>"Region of Enrollment", "classes"=>[{"title"=>"United States", "categories"=>[{"measurements"=>[{"value"=>"274", "groupId"=>"BG000"}, {"value"=>"274", "groupId"=>"BG001"}, {"value"=>"368", "groupId"=>"BG002"}, {"value"=>"916", "groupId"=>"BG003"}]}]}, {"title"=>"Canada", "categories"=>[{"measurements"=>[{"value"=>"37", "groupId"=>"BG000"}, {"value"=>"38", "groupId"=>"BG001"}, {"value"=>"50", "groupId"=>"BG002"}, {"value"=>"125", "groupId"=>"BG003"}]}]}], "paramType"=>"NUMBER", "unitOfMeasure"=>"participants"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>1041}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1991-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2014-02", "completionDateStruct"=>{"date"=>"2012-03", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2014-02-20", "studyFirstSubmitDate"=>"1999-10-27", "resultsFirstSubmitDate"=>"2013-10-16", "studyFirstSubmitQcDate"=>"1999-10-27", "lastUpdatePostDateStruct"=>{"date"=>"2014-04-03", "type"=>"ESTIMATED"}, "resultsFirstSubmitQcDate"=>"2014-02-20", "studyFirstPostDateStruct"=>{"date"=>"1999-10-28", "type"=>"ESTIMATED"}, "resultsFirstPostDateStruct"=>{"date"=>"2014-04-03", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1999-10", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period", "timeFrame"=>"At the end of treatment, 4-6 years from baseline assessment", "description"=>"Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). 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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."}, {"measure"=>"Standardized Depression Scale -- Children's Depression Inventory", "timeFrame"=>"4-6 years from baseline", "description"=>"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."}]}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"conditions"=>["Asthma", "Lung Diseases"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9892029", "type"=>"BACKGROUND", "citation"=>"Design and implementation of a patient education center for the Childhood Asthma Management Program. Childhood Asthma Management Program Research Group. 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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"=>"10756221", "type"=>"BACKGROUND", "citation"=>"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"=>"11027739", "type"=>"BACKGROUND", "citation"=>"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. 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Child Neuropsychol. 2005 Aug;11(4):333-48. doi: 10.1080/09297040490916929."}, {"pmid"=>"16179640", "type"=>"BACKGROUND", "citation"=>"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"=>"15937295", "type"=>"BACKGROUND", "citation"=>"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"=>"32118022", "type"=>"DERIVED", "citation"=>"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"=>"31187518", "type"=>"DERIVED", "citation"=>"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"=>"30585438", "type"=>"DERIVED", "citation"=>"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"=>"29940952", "type"=>"DERIVED", "citation"=>"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"=>"27980782", "type"=>"DERIVED", "citation"=>"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"=>"27367781", "type"=>"DERIVED", "citation"=>"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"=>"27168434", "type"=>"DERIVED", "citation"=>"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"=>"26164807", "type"=>"DERIVED", "citation"=>"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"=>"25115882", "type"=>"DERIVED", "citation"=>"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"=>"22938716", "type"=>"DERIVED", "citation"=>"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"=>"21991891", "type"=>"DERIVED", "citation"=>"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"=>"20018959", "type"=>"DERIVED", "citation"=>"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."}]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"BACKGROUND:\n\nAsthma 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 than adults.\n\nHospitalizations 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 population.\n\nDeath 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.\n\nCurrent 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.\n\nThus, 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.\n\nTwo 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.\n\nWhen 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.\n\nThe 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.\n\nDESIGN NARRATIVE:\n\nChildren 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.\n\nThe 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"12 years", "minimumAge"=>"5 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion criteria:\n\n* Age 5 to 12 years at time of screening\n* Chronic asthma as evidenced by one or more of the following historical findings for at least 6 months during the past year:\n* Asthma symptoms at least 2 times per week\n* 2 or more usages per week of an inhaled bronchodilator\n* Daily asthma medication\n* 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\n* Methacholine sensitivity: estimated PC20 FEV1 less than or equal to 12.5 mg/ml\n* Consent of guardian and assent of child\n* Ability to comply with trial for 5 - 6.5 years\n\nExclusion criteria:\n\n* Presence of one or more of the following confounding or complicating problems:\n* Any other active pulmonary disease\n* Any chronic condition presumed to interfere with the successful completion of the project or confound its interpretation\n* Pulmonary function testing findings suggesting a ventilatory defect other than asthma, or evidence of existing irreversible lung damage\n* Severe chronic sinusitis or nasal polyposis\n* Introduction of or a change in allergen immunotherapy within the past month\n* Use of more than 4 sprays of nasal steroids daily (only beclomethasone allowed)\n* Pregnancy\n* Current use of metoclopramide, ranitidine, or cimetidine\n* Treatment for gastroesophageal reflux\n* Participation in another drug study\n* Evidence of severe asthma as indicated by one or more of the following:\n* Two or more hospitalizations for asthma in the past year\n* Six or more steroid bursts in the past year\n* Demonstrated need for continuous use of glucocorticoids, either oral or inhaled\n* When off inhaled O2-agonist for more than 4 hrs and theophylline for more than 24 hrs, FEV1 less than 65% predicted\n* Intubation for asthma at any time in the past\n* 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\n* Inability to perform 3 acceptable FVC maneuvers of which at least 2 reproducible FEV1s are within 10% of the largest FEV1\n* Inability to complete the methacholine challenge or methacholine PC20 FEV1 greater than 12.5 mg/ml\n* Evidence that patient or family may be unreliable or non-compliant or may move from the metropolitan area before trial completion"}, "identificationModule"=>{"nctId"=>"NCT00000575", "acronym"=>"CAMP", "briefTitle"=>"Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)", "organization"=>{"class"=>"OTHER", "fullName"=>"Johns Hopkins Bloomberg School of Public Health"}, "officialTitle"=>"Childhood Asthma Management Program", "orgStudyIdInfo"=>{"id"=>"213"}, "secondaryIdInfos"=>[{"id"=>"5U01HL075417", "link"=>"https://reporter.nih.gov/quickSearch/5U01HL075417", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"1 Budesonide", "description"=>"Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn", "interventionNames"=>["Drug: Budesonide"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"2 Nedocromil", "description"=>"Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn", "interventionNames"=>["Drug: Nedocromil"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"3 Placebo", "description"=>"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.", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"Placebo", "type"=>"DRUG", "description"=>"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.", "armGroupLabels"=>["3 Placebo"]}, {"name"=>"Nedocromil", "type"=>"DRUG", "otherNames"=>["Tilade"], "description"=>"Four 2 mg puffs bid + two 90 Og puffs albuterol prn", "armGroupLabels"=>["2 Nedocromil"]}, {"name"=>"Budesonide", "type"=>"DRUG", "otherNames"=>["Pulmicort"], "description"=>"Two 100 Og puffs bid + two 90 Og puffs albuterol prn.", "armGroupLabels"=>["1 Budesonide"]}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"N. F. Adkinson, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Johns Hopkins University"}, {"name"=>"Anne Fuhlbrigge, MD, MS", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Brigham and Women's Hospital"}, {"name"=>"H. W. Kelly, PharmD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of New Mexico"}, {"name"=>"Padmaja Subbarao, MD, MSc", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"The Hospital for Sick Children"}, {"name"=>"Paul Williams, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Asthma, Inc."}, {"name"=>"Robert Strunk, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Washington University School of Medicine"}, {"name"=>"Stanley Szefler, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Jewish Health"}, {"name"=>"James Tonascia, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Johns Hopkins University"}, {"name"=>"Robert Zeiger, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of California, San Diego"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Johns Hopkins Bloomberg School of Public Health", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}, {"name"=>"CAMP Steering Committee", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator, CAMP Data Coordinating Center", "investigatorFullName"=>"James Tonascia", "investigatorAffiliation"=>"Johns Hopkins Bloomberg School of Public Health"}}}}