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:
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.
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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 -