The childhood asthma management program (CAMP): Design, rationale, and methods

Controlled Clinical Trials

Volumn 20, Issue 1, 1999, Pages 91-120

  Shapiro, Gail G ^a   DuHamel, Thomas R ^a   Wighton, Timothy G ^a   Chinn, Tamara ^a   Bierman, C Warren ^a   Furukawa, Clifton T ^a   Altman, Leonard C ^a   Virant, Frank S ^a   Williams, Paul V ^a   Minotti, Dominick A ^a   Kennedy, Michael S ^a   Becker, Jonathan W ^a   Reagan, Chris ^a   Eliassen, Heather ^a   Crawford, Dan ^a   Hammond, Babi ^a   Strodtbeck, Grace ^a   Sharpe, Marian ^a   Weiss, Scott ^b   Greineder, Dirk ^b   Torda, Walter ^b   Tata, Martha ^b   Barrant, Peter ^b   DeFilippo, Anthony ^b   Grace, Mary ^b   Haynes, Stephanie ^b   Higham, Margaret ^b   Kelleher, Susan ^b   Koslof, Jay ^b   Madden, Nancy ^b   Mandel, Dana ^b   Martinez, Agnes ^b   McAuliffe, Jean ^b   Pacella, Paola ^b   Parks, Paula ^b   Plunkett, Anne ^b   Seligsohn, Kay ^b   Traylor, June ^b   Van Horn, Melissa ^b   Ware, Janice ^b   Wells, Carolyn ^b   Whitman, Ann ^b   Reisman, Joe ^c   MacLusky, Ian ^c   Levison, Henry ^c   Hall, Anita ^c   Benedet, Yola ^c   Chay, Jennifer ^c   Collinson, Michelle ^c   Finlayson Kulchin, Jane ^c   Gore, Kenneth ^c   Miki, Melody ^c   Sananes, Renée ^c   Adkinson, N Franklin ^d   Eggleston, Peyton ^d   Huss, Karen ^d   Plotnick, Leslie ^d   Pulsifer, Margaret ^d   Rand, Cynthia ^d   Wheeler, Barbara ^d   Bollers, Nancy ^d   Hyatt, Kimberly ^d   Leritz, Betsy ^d   Pessaro, Mildred ^d   Philips, Stephanie ^d   Szefler, Stanley ^e   Nelson, Harold S ^e   Sundstrom D ^e   Bender, Bruce ^e   Brelsford, Kristin ^e   Gleason, Melanie ^e   Hassell, Joseph ^e   Hendrickson, Caroline ^e   Irvin, Charles G ^e   Junk, Tara ^e   Liu, Andrew ^e   Spahn, Joseph ^e   White, Michael P ^e   Feeley, Jeryl ^e   Bridges, Jessyca ^e   Ciacco, Jody ^e   Eltz, Michael ^e   Flynn, Michael ^e   Hefner, Marcia ^e   Hettleman, Daniel ^e   Jacobs, Jeffrey ^e   Kamada, Alan ^e   Nimmagadda, Sai ^e   Sandoval, Kendra ^e   Sheridan, Jessica ^e   Washington, Trella ^e   Willcutt, Eric ^e   Zeiger, Robert ^f   Horner, Anthony ^f   Friedman, Noah ^f   Jalowayski, Al ^f   Lincoln, Alan ^f   Mellon, Michael H ^f   Schatz, Michael ^f   Harden, Kathleen ^f   Galbreath, Linda L ^f   Hanson, Ellen ^f   Jenson, Elaine M ^f   King, Shirley ^f   Lopez, Brian ^f   Magiari, Michaela ^f   Nelle, Catherine A ^f   Pizzo, Senia ^f   Rodriquez, Eva ^f   Easton, James G ^f   Mostafa, Kathleen ^f   Moscona, Avraham ^f   Sandoval, Karen ^f   McWilliams, Bennie ^g   Annett, Robert ^g   Kelly, H William ^g   Spicher, Mary ^g   Becker, Diane ^g   Bereket, Selda ^g   Braun, Marisa ^g   Bush, Shannon ^g   Hunt, David ^g   Moreshead, Margaret ^g   Ortega, Barbara ^g   Strunk, Robert C ^h   Bloomberg, Gordon R ^h   Corry, James M ^h   Smith, Thomas F ^h   Albers, Ellen ^h   Davantes, Bernadette ^h   Belle, Gregg ^h   Dolinsky, Marisa ^h   Fisher, Edwin B ^h   Gaioni, Stephen J ^h   Glynn, Emily ^h   Herman, Cathy ^h   Kemp, Debra ^h   Lawhon, Claire ^h   Meltzer, Sharon ^h   Moseid, Cynthia ^h   Oliver Welker, Tina ^h   Rodgers, Denise ^h   Turner, Carl ^h   White, Deborah K ^h   Caesar, Mary ^h   Richardson, Diana S ^h   Ryan, Elizabeth ^h   Sylvia, Susan C ^h   Cherniack, Reuben ^e   Tonascia, James ⁱ   Meinert, Curtis ⁱ   Amend Libercci, Debra ⁱ   Belt, Patricia ⁱ   Collins, Karen ⁱ   Collison, Betty ⁱ   Dawson, Christopher ⁱ   Dodge, John ⁱ   Donithan, Michele ⁱ   Easton, Dawn ⁱ   Edmonds, Vera ⁱ   Ewing, Cathleen ⁱ   Harle, Judith ⁱ   Huffman, Robert ⁱ   Liang, Kung Yee ⁱ   Meinert, Jill ⁱ   Nowakowski, Deborah ⁱ   Owens, Rosetta ⁱ   Smith, Michael ⁱ   Sternberg, Alice ⁱ   Van Natta, Mark ⁱ   Wise, Robert ⁱ   Rice, Robert ^j   Hughes, Bob ^j   Lynch, Tom ^j   Vadlamani, Sarma ^j   Hamilton, Robert G ^d,k   Schatz, Carol ^k   Wisenauer, Jack ^k   Harbeck, Ronald J ^e   Emerick, Rhonda ^e   Watson, Brian ^e   Culkin, Cindi ^e   Oliver, Sarah ^e   Lung, Colleen Lum ^e   Mullen, Ann ^e   Taggart, Virginia ^l   Randall, Pamela ^l   Albert, Paul ^l   Hurd, Suzanne ^l   Kiley, James ^l   Wu, Margaret ^l   Parker, Sydney ^l   Letvenko, William ^m   Repko, William ^m   Poust, Rolland ⁿ   Herold, David ⁿ   Elbert, Dennis ⁿ   Eigen, Howard ^o   Cloutier, Michelle ^o   Connett, John ^o   Cuttler, Leona ^o   Davis, Clarence E ^o   Evans, David ^o   Kattan, Meyer ^o   Leikin, Sanford ^o   Menendez, Rogelio ^o   Simons, F Estelle R ^o   Meinert, Curtis L ^o   more..

^a Asthma Inc   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c HOSPITAL FOR SICK CHILDREN   (Canada)

^d JOHNS HOPKINS ASTHMA AND ALLERGY CENTER   (United States)

^e NATIONAL JEWISH MEDICAL AND RESEARCH CENTER   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g UNIVERSITY OF NEW MEXICO   (United States)

^h WASHINGTON UNIVERSITY   (United States)

ⁱ JOHNS HOPKINS UNIVERSITY   (United States)

^j McKesson BioServices   (United States)

^k JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^l NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^m SandM Instrument Company   (United States)

ⁿ UNIVERSITY OF IOWA   (United States)

^o Division of Pharmaceutical Services ^*

more..

Author keywords

Albuterol; Allergens; Anti inflammatory agents; Atopy; Bronchial provocation test; Bronchodilator agents; Budesonide; Childhood asthma; Clinical trials; Environmental exposure; Glucocorticoids; Growth; Inhaled bronchodilator; Nedocromil; Psychological test; Spirometry

Indexed keywords

BUDESONIDE; METHACHOLINE; NEDOCROMIL; NEDOCROMIL SODIUM; PLACEBO; SALBUTAMOL;

ARTICLE; ASTHMA; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; EDUCATION; ENVIRONMENT; FEMALE; FOLLOW UP; FORCED EXPIRATORY VOLUME; HUMAN; INHALATIONAL DRUG ADMINISTRATION; INHALER; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; METERED DOSE INHALER; MULTICENTER STUDY; PATIENT INFORMATION; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIAL; SCREENING; SPIROMETRY;

EID: 0033012176     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(98)00044-0     Document Type: Article

References (80)

1. National Heart Lung, Blood Institute National Asthma Education Program Expert Panel Report. guidelines for the diagnosis and management of asthma J Allergy Clin Immunol. 88:1991;425-534.
2. Gergen P.J., Mullally D.I., Evans R. III National survey of prevalence of asthma among children in the United States, 1976 to 1980. Pediatrics. 81:1988;1-7.
3. Mak H., Johnston P., Abbey H., Talamo R.C. Prevalence of asthma and health service utilization of asthmatic children in an inner city. J Allergy Clin Immunol. 70:1982;367-372.
4. Halfon N., Newacheck P.W. Trends in the hospitalization for acute childhood asthma, 1970-84. Am J Publ Health. 76:1986;1308-1311.
5. Evans D., Clark N.M., Feldman C.H.et al. A school health education program for children with asthma aged 8-11 years. Health Educ Q. 14:1987;267-279.
6. Weiss S.T., Tosteson T.D., Segal M.R.et al. Effects of asthma on pulmonary function in children. a longitudinal population-based study Am Rev Respir Dis. 145:1992;58-64.
7. Fletcher C., Peto R., Tinker C., Speizer F.E. The National History of Chronic Bronchitis and Emphysema. an Eight-year Study of Early Chronic Obstructive Lung Disease in Working Men in London:1976;Oxford University Press, New York.
8. Dutoit J.I., Salome C.M., Woolcock A.J. Inhaled glucocorticoids reduce the severity of bronchial hyperresponsiveness in asthma but oral theophylline does not. Am Rev Respir Dis. 136:1987;1174-1178.
9. Svendsen U.G., Frolund L., Madsen F.et al. A comparison of the effects of sodium cromoglycate and beclomethasone dipropionate on pulmonary function and bronchial hyperreactivity in subjects with asthma. J Allergy Clin Immunol. 80:1987;68-74.
10. Svendsen U.G., Frolund L., Madsen F., Nielsen N.H. A comparison of the effects of nedocromil sodium and beclomethasone dipropionate on pulmonary function, symptoms, and bronchial responsiveness in patients with asthma. J Allergy Clin Immunol. 84:1989;224-231.
11. Gonzalez J.P., Brogden R.N. Nedocromil sodium. a preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of reversible obstructive airway disease Drugs. 34:1987;560-577.
12. Murphy S. Cromolyn sodium. Jenne J.W., Murphy S. Drug Therapy for Asthma. Research and Clinical Practice:1987;Marcel Dekker, New York.
13. Brogden R.N., McTavish D. Budesonide. an updated review of its pharmacological properties, and therapeutic efficacy in asthma and rhinitis Drugs. 44:1992;375-407.
14. Hollman G.A., Allen D.B. Overt glucocorticoid excess due to inhaled corticosteroid therapy. Pediatrics. 81:1988;452-455.
15. Littlewood JM, Johnson AW, Edward PA, Littlewood AE. Growth retardation in asthmatic children treated with inhaled beclomethasone dipropionate. Lancet 1988;i:115-116.
16. Capewell S., Reynolds S., Shuttleworth D.et al. Purpura and dermal thinning associated with high dose inhaled corticosteroids. BMJ. 300:1990;1548-1551.
17. Ali N.J., Capewell S., Ward M.J. Bone turnover during high dose inhaled corticosteroid therapy. Thorax. 44:1991;900.
18. Pouw E.M., Prummel M.F., Oosting H.et al. Beclomethasone inhalation decreases serum osteocalcin concentrations. BMJ. 302:1991;627-628.
19. Wolthers O.D., Pedersen S. Growth of asthmatic children during treatment with budesonide. a double-blind trial BMJ. 303:1991;163-165.
20. Wolthers O.D., Pedersen S. Controlled study of linear growth in asthmatic children during treatment with inhaled glucocorticosteroids. Pediatrics. 89:1992;839-842.
21. Tinkelman D.G., Reed C.E., Nelson H.S., Offord K.P. Aerosol beclomethasone dipropionate compared with theophylline as primary treatment of chronic, mild to moderately severe asthma in children. Pediatrics. 92:1993;64-77.
22. Agertoft L., Pedersen S. Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respir Med. 86:1994;373-381.
23. Doull I.J.M., Freezer N.J., Holgate S.T. Growth of pepubertal children with mild asthma treated with inhaled beclomethasone dipropionate. Am J Respir Crit Care Med. 151:1995;1715-1719.
24. Pedersen S. Important issues in childhood asthma. Eur Respir J. 6:1996;192-196.
25. Pedersen S. Efficacy and safety of inhaled corticosteroids in children. Schleimer R.P., Busse W.W., O'Byrne P.M. Inhaled Glucocorticoids in Asthma. 1997;Marcel Dekker, New York.
26. Chung KF, Wiggins J, Collins J. In: Weiss EB, Stein M, eds. Bronchial Asthma: Mechanisms and Therapeutics 3rd ed. Boston: Little, Brown; 1993.
27. Eggleston P.A., Szefler S.J. Asthma in children. Busse W.W., Holgate S.T. Asthma and Rhinitis. 1995;Blackwell, Boston.
28. Kamada A.K., Szefler S.J. Glucocorticoids and growth in asthmatic children. Pediatr Allergy Immunol. 6:1995;145-154.
29. Childhood Asthma Management Program Study Group Childhood Asthma Management Program Forms and Charts Notebook (Accession No. PB95-137204). 1994;National Technical Information Service, Springfield, VA.
30. Childhood Asthma Management Program Study Group Childhood Asthma Management Program Protocol (Accession No. PB95-137105). 1994;National Technical Information Service, Springfield, VA.
31. Weinberger M., Hendeles L. Theophylline. Middleton E., Reed C.E., Ellis E.F.et al. Allergy. Principles and Practice:1993;Mosby, St. Louis, MO.
32. Szefler S.J., Bender B.G., Jusko W.J.et al. Evolving role of theophylline for treatment of chronic childhood asthma. J Pediatr. 127:1995;176-185.
33. Sears M.R., Taylor R.D., Print C.G.et al. Regular inhaled beta-agonist treatment in bronchial asthma. Lancet. 336:1990;1391-1396.
34. Spitzer W.O., Suissa S., Ernst P.et al. The use of beta-agonists and the risk of death and near death from asthma. N Engl J Med. 326:1992;501-506.
35. Brattsand R., Thalen A., Roempke K.et al. Development of new glucocorticosteroids with a very high ratio between topical and systemic activities. Eur J Respir Dis. 63(suppl 122):1982;62-73.
36. Nyholm E., Frame M.H., Cayton R.M. Therapeutic advantages of twice-daily over four-time daily inhalation budesonide in the treatment of chronic asthma. Eur J Respir Dis. 65:1984;339-345.
37. Bruijnzeel P.L.B., Warrings R.A.J., Kok P.T.M.et al. Effects of nedocromil sodium on in vitro induced migration, activation and mediator release from human granulocytes. J Allergy Clin Immunol. 92:1993;159-164.
38. Joseph M., Tsicopoulos A., Tonnel A.B., Capron A. Modulation by nedocromil sodium of immunologic and nonimmunologic activation of monocytes, macrophages, and platelets. J Allergy Clin Immunol. 92:1993;165-170.
39. Pearce F.L. Effect of nedocromil sodium on mediator release from mast cells. J Allergy Clin Immunol. 92:1993;155-158.
40. del Bufalo C., Fasano L., Patalano F., Gonella G. Inhibition of fog-induced bronchoconstriction by nedocromil sodium and sodium cromoglycate in intrinsic asthma. a double-blind, placebo-controlled study Respiration. 55:1989;181-185.
41. Orefice U., Struzzo P., Dorigo R., Peratoner A. Long-term treatment with sodium cromoglycate, nedocromil sodium and beclomethasone dipropionate reduces bronchial hyperresponsiveness in asthmatic subjects. Respiraton. 59:1992;97-101.
42. Sont J.K., Bel E.R., Dijkman J.H., Sterk P.J. The long-term effect of nedocromil sodium on the maximal degree of airway narrowing to methacholine in atopic asthmatic subjects. Clin Exp Allergy. 22:1992;554-560.
43. Callaghan B., Teo N.C., Clancy L. Effects of the addition of nedocromil sodium to maintenance bronchodilator therapy in the management of chronic asthma. Chest. 101:1992;787-892.
44. Schwartz H.J., Kemp J.P., Blanco S.et al. Highlights of the nedocromil sodium clinical study presentations. J Allergy Clin Immunol. 92:1993;204-209.
45. Dupont W.D., Plummer W.D. Jr. Power and sample size calculations. a review and computer program Controlled Clin Trials. 11:1990;116-128.
46. Van Essen-Zandvliet E.E., Hughes M.D., Waalkens J.K.et al. Effects of 22 months of treatment with inhaled corticosteroids and/or beta-2-agonists on lung function, airway responsiveness and symptoms in children with asthma. Am Rev Respir Dis. 146:1992;547-554.
47. Childhood Asthma Management Program Research Group. Design and implementation of a patient education center for the Childhood Asthma Management Program. Ann Allergy Asthma Immunol (in press).
48. Wechsler D. Manual for the Preschool and Primary Scale of Intelligence. 1989;Psychological Corporation, San Antonio, TX. (Revised.
49. Wechsler D. Manual for the Wechsler Intelligence Scale for Children. 3rd ed:1991;Psychological Corporation, San Antonio, TX.
50. Woodcock R.W., Johnson M.B. Manual for the Woodcock-Johnson Psycho-Educational Battery Tests of Achievement (Revised). 1990;Teaching Resources, Allen, TX.
51. Adams W., Sheslow D. Manual for the Wide Range of Assessment of Memory and Learning. 1990;Jastak Associates, Wilmington, DE.
52. Gordon M., Mettelman B.B. Technical Guide to the Gordon Diagnostic System Model III-R. 1987;Gordon Systems, DeWitt, NY.
53. Reynolds C.R., Richmond B.O. Revised Children Manifest Anxiety Scale (RCMAS). 1985;Western Psychological Services, Los Angeles.
54. Kovacs M. Rating scales to assess depression in school-aged children. Acta Paedopsychiatrica. 46:1981;305-315.
55. La Greca A.M., Dandes S.K., Wick P., Shaw K., Stone W.L. The development of the Social Anxiety Scale for Children (SASC). reliability and concurrent validity J Clin Child Psychol. 17:1988;84-91.
56. La Greca A.M., Stone W.L. The Social Anxiety Scale for Children - Revised. factor structure concurrent validity J Pediatr Psychol. 15:1993;87-305.
57. Achenbach T. Manual for Youth Self Report and 1991 Profile. 1991;University of Vermont Department of Psychiatry, Burlington, VT.
58. Achenbach T. Manual for the Child Behavior Checklist/4-18 and 1991 Profile. 1991;University of Vermont Department of Psychiatry, Burlington, VT.
59. Moos R.H., Moos B.S. Family Environment Scale (FES) Manual. 1981;Consulting Psychologists Press, Palo Alto, CA.
60. Stein R.E.K., Riessman C.K. The development of an Impact-on-Family scale. Preliminary findings Med Care. 18:1980;465-472.
61. Sherbourne C.D., Stewart A.L. The MOS social support survey. Soc Sci Med. 32:1991;705-714.
62. Grizzle J.E. A note on stratifying versus complete random assignment in clinical trials. Controlled Clin Trials. 3:1982;365-368.
63. Barnes P.J., Pedersen S. Efficacy and safety of inhaled corticosteroids in asthma. Am Rev Respir Dis. 148(suppl):1993;S1-S26.
64. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Educator's Manual. 1997;National Technical Information Service, Springfield, VA. (Accession No. PB97-134563).
65. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Patient Education Notebook (Parent Version). 1994;National Technical Information Service, Springfield, VA. (Accession No. PB95-137147).
66. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Patient Education Notebook (Kindergarten Through Third Grade Version). 1994;National Technical Information, Springfield, VA. (Accession No. PB95-137139).
67. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Patient Education Notebook (Fourth Through Sixth Grade Version). 1994;National Technical Information Service, Springfield, VA. (Accession No. PB95-137121).
68. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Spirometry Manual, Version 3.0. 1994;National Technical Information Service, Springfield, VA. (Accession No. PB95-137113).
69. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Manual for Methacholine Challenge Testing, Version 3.0. 1994;National Technical Information Service, Springfield, VA. (Accession No. PB95-137154).
70. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Somatic Growth Measures Manual, Version 1.0. 1994;National Technical Information Service, Springfield, VA. (Accession No. PB95-137170).
71. Childhood Asthma Management Program Behavioral Scientists Group Childhood Asthma Management Program Behavioral Scientists Group Test Administration and Scoring Manual, Version 4.0 (Accession No. PB95-137196). 1994;National Technical Information Service, Springfield, VA.
72. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Dust and Serum Specimen Manual, Version 2.0. 1994;National Technical Information Service, Springfield, VA. (Accession No. PB95-137162).
73. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Allergy and Skin Test Manual, Version 2.0. 1994;National Technical Information Service, Springfield, VA. (Accession No. PB95-137188).
74. Childhood Asthma Management Program Research Group Childhood Asthma Management Program Data System Manual. 1997;National Technical Information Service, Springfield, VA. (Accession No. PB97-134571).
75. Liang K.Y., Zeger S.L. Longitudinal data analysis using generalized linear models. Biometrika. 73:1986;13-22.
76. McCullagh P., Nelder J.A. Generalized Linear Models. 2nd ed:1989;Chapman & Hall, New York.
77. Strunk R.C., Mrazek D.A., Wolfson-Fuhrmann G.S., LaBrecque J.F. Physiologic and psychological characteristics associated with deaths due to asthma in childhood. A case controlled study JAMA. 254:1985;1193-1198.
78. Strunk R.C., Fisher E.B. Risk factors for morbidity and mortality in asthma. Szefler S.J., Leung D.Y.M. Severe Asthma. Pathogenesis and Clinical Management:1996;Marcel Dekker, New York.
79. Wamboldt M.Z., Wamboldt F.S. Psychosocial aspects of severe asthma in children. Szefler S.J., Leung D.Y.M. Severe Asthma. Pathogenesis and Clinical Management:1996;Marcel Dekker, New York.
80. National Asthma Education Program. Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma Washington, DC: (Publication No. 913041). U.S. Department of Health and Human Services Public Health Service, National Institutes of Health; August 1991.