TY - JOUR
T1 - Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma
T2 - The Pediatric Asthma Controller Trial
AU - Sorkness, Christine A.
AU - Lemanske, Robert F.
AU - Mauger, David T.
AU - Boehmer, Susan J.
AU - Chinchilli, Vernon M.
AU - Martinez, Fernando D.
AU - Strunk, Robert C.
AU - Szefler, Stanley J.
AU - Zeiger, Robert S.
AU - Bacharier, Leonard B.
AU - Bloomberg, Gordon R.
AU - Covar, Ronina A.
AU - Guilbert, Theresa W.
AU - Heldt, Gregory
AU - Larsen, Gary
AU - Mellon, Michael H.
AU - Morgan, Wayne J.
AU - Moss, Mark H.
AU - Spahn, Joseph D.
AU - Taussig, Lynn M.
N1 - Funding Information:
Disclosure of potential conflict of interest: C. A. Sorkness has consultant arrangements with GlaxoSmithKline and AstraZeneca, has received grant support from GlaxoSmithKline and Pharmaxis, and is on the speakers' bureau for GlaxoSmithKline and Genentech. R. F. Lemanske has consultant arrangements with GlaxoSmithKline, Merck, AstraZeneca, Aventis, and Novartis, has received grant support from the National Heart, Lung, and Blood Institute (NHLBI), and is on the speakers' bureau for Merck, AstraZeneca, GlaxoSmithKline, and Aventis. D. T. Mauger, S. J. Boehmer, and V. M. Chinchilli have received grant support from the National Institutes of Health (NIH). F. D. Martinez has had consultant arrangements with Genentech and Pfizer, has served on the advisory board for Merck, and has received an honorarium for a lecture at a meeting sponsored by Merck. S. J. Szefler has consultant arrangements with AstraZeneca, GlaxoSmithKline, Aventis, Genentech, and Merck, and has received grant support from the NIH, NHLBI, National Institute of Allergy and Infectious Diseases, and Ross Pharmaceuticals. R. S. Zeiger has consultant arrangements with Aerocrine, AstraZeneca, Genentech, GlaxoSmithKline, Merck, Novartis, and Sanofi-Aventis, and has received grant support from AstraZeneca, GlaxoSmithKline, Merck, Sanofi-Aventis, and TEVA Pharmaceuticals. L. B. Bacharier has received grant support from the NIH and NHLBI, and is on the speakers' bureau for Merck, GlaxoSmithKline, AstraZeneca, and Genentech. R. A. Covar has received grant support from AstraZeneca. T. W. Guilbert has participated on an advisory board sponsored by GlaxoSmithKline and as a consultant in the design of Continuing Medical Education (CME) courses and for asthma for the Innovia Medical Educational Institute, and has received consultant fees from GlaxoSmithKline and stocks or revenue from speakers' bureaus, research, or grant activities from GlaxoSmithKline, AstraZeneca, Merck, and Pfizer, and is on the speakers' bureau for GlaxoSmithKline, AstraZeneca, SOMA Medical Education (CME), Innovia Medical Education Institute (CME), Antidote (formerly Medical World Conferences, CME), and Health Matters. G. Larsen has consultant arrangements with GlaxoSmithKline and Schering Plough, and has received grant support from the NIH. M. H. Mellon is on the speakers' bureau for AstraZeneca, Schering Plough, and Altana. W. J. Morgan has consultant arrangements with Genentech and has patent licensing arrangements with the Wisconsin Alumni Research Foundation. J. D. Spahn has consultant arrangements with GlaxoSmithKline and AstraZeneca, has received grant support from Merck, AstraZeneca, and GlaxoSmithKline, and is on the speakers' bureau for GlaxoSmithKline. L. M. Taussig has consultant arrangements with GlaxoSmithKline. The rest of the authors have declared that they have no conflict of interest.
Funding Information:
Supported by grants HL064307, HL64288, HL064295, HL64287, and HL064305 from the National Heart, Lung and Blood Institute. This study was performed in part by the General Clinical Research Centers at Washington University School of Medicine (M01 RR00036), National Jewish Medical and Research Center (M01 RR00051), and the University of Wisconsin (M01 RR03186).
PY - 2007/1
Y1 - 2007/1
N2 - Background: More evidence is needed on which to base recommendations for treatment of mild-moderate persistent asthma in school-aged children. Objective: The Pediatric Asthma Controller Trial (PACT) compared the effectiveness of 3 regimens in achieving asthma control. Methods: A total of 285 children (ages 6-14 years) with mild-moderate persistent asthma on the basis of symptoms, and with FEV1 ≥ 80% predicted and methacholine FEV1 PC20 ≤ 12.5 mg/mL, were randomized to 1 of 3 double-blind 48-week treatments: fluticasone 100 μg twice daily (fluticasone monotherapy), fluticasone 100 μg/salmeterol 50 μg in the morning and salmeterol 50 μg in the evening (PACT combination), and montelukast 5 mg in the evening. Outcomes included asthma control days (primary outcome), exacerbations, humanistic measurements, and pulmonary function measurements. Results: Fluticasone monotherapy and PACT combination were comparable in many patient-measured outcomes, including percent of asthma control days, but fluticasone monotherapy was superior for clinic-measured FEV1/forced vital capacity (P = .015), maximum bronchodilator response (P = .009), exhaled nitric oxide (P < .001), and PC20 (P < .001). Fluticasone monotherapy was superior to montelukast for asthma control days (64.2% vs 52.5%; P = .004) and for all other control outcomes. Growth over 48 weeks was not statistically different (fluticasone, 5.3 cm; PACT combination, 5.3 cm; montelukast, 5.7 cm). Conclusion: Both fluticasone monotherapy and PACT combination achieved greater improvements in asthma control days than montelukast. However, fluticasone monotherapy was superior to PACT combination in achieving other dimensions of asthma control. Growth was similar in all groups. Clinical implications: Therefore, of the regimens tested, the PACT study findings favor fluticasone monotherapy in treating children with mild-moderate persistent asthma with FEV1 ≥ 80% predicted, confirming current guideline recommendations.
AB - Background: More evidence is needed on which to base recommendations for treatment of mild-moderate persistent asthma in school-aged children. Objective: The Pediatric Asthma Controller Trial (PACT) compared the effectiveness of 3 regimens in achieving asthma control. Methods: A total of 285 children (ages 6-14 years) with mild-moderate persistent asthma on the basis of symptoms, and with FEV1 ≥ 80% predicted and methacholine FEV1 PC20 ≤ 12.5 mg/mL, were randomized to 1 of 3 double-blind 48-week treatments: fluticasone 100 μg twice daily (fluticasone monotherapy), fluticasone 100 μg/salmeterol 50 μg in the morning and salmeterol 50 μg in the evening (PACT combination), and montelukast 5 mg in the evening. Outcomes included asthma control days (primary outcome), exacerbations, humanistic measurements, and pulmonary function measurements. Results: Fluticasone monotherapy and PACT combination were comparable in many patient-measured outcomes, including percent of asthma control days, but fluticasone monotherapy was superior for clinic-measured FEV1/forced vital capacity (P = .015), maximum bronchodilator response (P = .009), exhaled nitric oxide (P < .001), and PC20 (P < .001). Fluticasone monotherapy was superior to montelukast for asthma control days (64.2% vs 52.5%; P = .004) and for all other control outcomes. Growth over 48 weeks was not statistically different (fluticasone, 5.3 cm; PACT combination, 5.3 cm; montelukast, 5.7 cm). Conclusion: Both fluticasone monotherapy and PACT combination achieved greater improvements in asthma control days than montelukast. However, fluticasone monotherapy was superior to PACT combination in achieving other dimensions of asthma control. Growth was similar in all groups. Clinical implications: Therefore, of the regimens tested, the PACT study findings favor fluticasone monotherapy in treating children with mild-moderate persistent asthma with FEV1 ≥ 80% predicted, confirming current guideline recommendations.
KW - Asthma Control Questionnaire
KW - Childhood asthma
KW - asthma control days
KW - exhaled nitric oxide
KW - fluticasone propionate
KW - forced vital capacity
KW - maximum bronchodilator response
KW - montelukast
KW - salmeterol
UR - http://www.scopus.com/inward/record.url?scp=33846032661&partnerID=8YFLogxK
U2 - 10.1016/j.jaci.2006.09.042
DO - 10.1016/j.jaci.2006.09.042
M3 - Article
C2 - 17140647
AN - SCOPUS:33846032661
SN - 0091-6749
VL - 119
SP - 64
EP - 72
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 1
ER -