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Family Medicine second FEV1 ; 50% of the predicted value18 and a 15% reversibility after a standard dose of an inhaled bronchodilator albuterol ; . Patients with a history of severe and or unstable asthma, long-term use of systemic steroids within 12 weeks of enrollment, or a history of intermittent use of systemic steroids within 30 days were excluded from the study. Patients also were excluded if they were hospitalized for treatment of airway obstruction within 30 days of enrollment, if they had upper or lower respiratory tract infections within 14 days of enrollment, or if they had any other concomitant lung diseases. All aspects of the study protocol were reviewed with the patients' parents or legal guardians, and informed written consent was obtained. The study protocol was approved by each center's Institutional Review Board and was performed according to the Declaration of Helsinki. Concurrent Medication Patients also were allowed their other usual medications for rhinitis or allergy, such as antihistamines, intranasal or topical GCSs, cromolyn, or immunotherapy if the treatment was constant during the baseline period and throughout the double-blind phase. Patients were not permitted to use any oral or inhaled GCS preparation other than the study medication during the double-blind period. Patients were allowed to use oral or inhaled short-acting bronchodilators as needed for breakthrough asthma symptoms. Study Design This multicenter, randomized, double-blind, placebocontrolled, parallel-group study involved 481 patients at 38 study centers located throughout the United States. The study period was from May 1995 to June 1996. The study consisted of a 2- to 3-week baseline screening period followed by a 12-week double-blind treatment period. Patients were required to visit their respective study site six times: at enrollment, at randomization, and after 2, 4, 8, and 12 weeks of treatment. At each clinic visit, a brief physical examination was performed, and daily diary records were reviewed. Spirometry testing was performed in a subset of patients who were capable of performing this procedure consistently. A comprehensive physical examination, clinical laboratory assessments hematology, blood chemistry, urinalysis ; , and documentation of reversibility of any airway obstruction were obtained in patients capable of performing the procedure ; at the enrollment visit and at the end of treatment. Diary cards were used daily to record the severity of nighttime and daytime asthma symptoms, morning and evening peak flow rates, and the number of days of bronchodilator use for breakthrough symptoms. The following scale was used to determine asthma symptom.
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1 2 Dyerberg J, Bang HO, Hjorne N. Fatty acid composition of the plasma lipids in Greenland Eskimos. J Clin Nutr 1975; 28: 958-66. Kris-Etherton PM, Taylor DS, Yu-Poth S, Huth P, Moriarty K, Fishell V, et al. Polyunsaturated fatty acids in the food chain in the United States. J Clin Nutr 2000; 71 suppl ; : S179-88. Kromhout D, Bosschieter EB, de Lezenne Coulander C. The inverse relation between fish consumption and 20-year mortality from coronary heart disease. N Engl J Med 1985; 312: 1205-9. Daviglus ML, Stamler J, Orencia AJ, Dyer AR, Liu K, Greenland P, et al. Fish consumption and the 30-year risk of fatal myocardial infarction. N Engl J Med 1997; 336: 1046-53. Hu FB, Bronner L, Willett WC, Stampfer MJ, Rexrode KM, Albert CM, et al. Fish and omega-3 fatty acid intake and risk of coronary heart disease in women. JAMA 2002; 287: 1815-21. Albert CM, Hennekens CH, O'Donnell CJ, Ajani UA, Carey VJ, Willett WC, et al. Fish consumption and risk of sudden cardiac death. JAMA 1998; 279: 23-8. Albert CM, Campos H, Stampfer MJ, Ridker PM, Manson JE, Willett WC, et al. Blood levels of long-chain n-3 fatty acids and the risk of sudden death. N Engl J Med 2002; 346: 1113-8. Ascherio A, Rimm EB, Stampfer MJ, Giovannucci EL, Willett WC. Dietary intake of marine n-3 fatty acids, fish intake, and the risk of coronary disease among men. N Engl J Med 1995; 332: 977-82. Marckmann P, Gronbaek M. Fish consumption and coronary heart disease mortality. A systematic review of prospective cohort studies. Eur J Clin Nutr 1999; 53: 585-90. Burr ML, Fehily AM, Gilbert JF, Rogers S, Holliday RM, Sweetnam PM, et al. Effects of changes in fat, fish, and fibre intakes on death and myocardial reinfarction: diet and reinfarction trial DART ; . Lancet 1989; 2: 757-61. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. Lancet 1999; 354: 447-55. Singh RB, Niaz MA, Sharma JP, Kumar R, Rastogi V, Moshiri M. Randomized, double-blind, placebo-controlled trial of fish oil and mustard oil in patients with suspected acute myocardial infarction: the Indian experiment of infarct survival--4. Cardiovasc Drugs Ther 1997; 11: 485-91. Nilsen DW, Albrektsen G, Landmark K, Moen S, Aarsland T, Woie L. Effects of a high-dose concentrate of n-3 fatty acids or corn oil introduced early after an acute myocardial infarction on serum triacylglycerol and HDL cholesterol. J Clin Nutr 2001; 74: 50-6. Burr ML, Ashfield-Watt PA, Dunstan FD, Fehily AM, Breay P, Ashton T, et al. Lack of benefit of dietary advice to men with angina: results of a controlled trial. Eur J Clin Nutr 2003; 57: 193-200. Christensen JH, Gustenhoff P, Korup E, Aaroe J, Toft E, Moller J, et al. Effect of fish oil on heart rate variability in survivors of myocardial infarction: a double blind randomised controlled trial. BMJ 1996; 312: 677-8. Leaf A, Kang JX, Xiao YF, Billman GE. Clinical prevention of sudden cardiac death by n-3 polyunsaturated fatty acids and mechanism of prevention of arrhythmias by n-3 fish oils. Circulation 2003; 107: 2646-52. Mori TA, Beilin LJ, Burke V, Morris J, Ritchie J. Interactions between dietary fat, fish, and fish oils and their effects on platelet function in men at risk of cardiovascular disease. Arterioscler Thromb Vasc Biol 1997; 17: 279-86. Kristensen SD, Iversen AM, Schmidt EB. n-3 polyunsaturated fatty acids and coronary thrombosis. Lipids 2001; 36 suppl ; : S79-82. 19 Thies F, Garry JM, Yaqoob P, Rerkasem K, Williams J, Shearman CP, et al. Association of n-3 polyunsaturated fatty acids with stability of atherosclerotic plaques: a randomised controlled trial. Lancet 2003; 361: 477-85. Heller A, Koch T, Schmeck J, van Ackern K. Lipid mediators in inflammatory disorders. Drugs 1998; 55: 487-96 De Caterina R, Liao JK, Libby P. Fatty acid modulation of endothelial activation. J Clin Nutr 2000; 71 suppl ; : S213-223. 22 Geleijnse JM, Giltay EJ, Grobbee DE, Donders AR, Kok FJ. Blood pressure response to fish oil supplementation: metaregression analysis of randomized trials. J Hypertens 2002; 20: 1493-9. Kris-Etherton PM, Harris WS, Appel LJ for the Nutrition Committee. AHA scientific statement. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation 2002; 106: 2747-57. Guallar E, Sanz-Gallardo MI, van't Veer P, Bode P, Aro A, Gomez-Aracena J, et al. Mercury, fish oils, and the risk of myocardial infarction Heavy Metals and Myocardial Infarction Study Group. N Engl J Med 2002; 347: 1747-54.
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