Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: the Pediatric Asthma Controller Trial.
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 FEV(1) >or= 80% predicted and methacholine FEV(1) PC(20) <or= 12.5 mg/mL, were randomized to 1 of 3 double-blind 48-week treatments: fluticasone 100 microg twice daily (fluticasone monotherapy), fluticasone 100 microg/salmeterol 50 microg in the morning and salmeterol 50 mug 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 FEV(1)/forced vital capacity (P = .015), maximum bronchodilator response (P = .009), exhaled nitric oxide (P < .001), and PC(20) (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).


CONCLUSIONS
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.


CONCLUSIONS
Therefore, of the regimens tested, the PACT study findings favor fluticasone monotherapy in treating children with mild-moderate persistent asthma with FEV(1) >or= 80% predicted, confirming current guideline recommendations.
Sorkness
Christine A
CA
Clinical Science Center, University of Wisconsin, Madison, WI 53792, USA. Sorkness@facstaff.wisc.edu
Lemanske
Robert F
RF
Mauger
David T
DT
Boehmer
Susan J
SJ
Chinchilli
Vernon M
VM
Martinez
Fernando D
FD
Strunk
Robert C
RC
Szefler
Stanley J
SJ
Zeiger
Robert S
RS
Bacharier
Leonard B
LB
Bloomberg
Gordon R
GR
Covar
Ronina A
RA
Guilbert
Theresa W
TW
Heldt
Gregory
G
Larsen
Gary
G
Mellon
Michael H
MH
Morgan
Wayne J
WJ
Moss
Mark H
MH
Spahn
Joseph D
JD
Taussig
Lynn M
LM
D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001827:Body Height / Q000187:drug effects; D002648:Child; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D011804:Quinolines / Q000627:therapeutic use*; D000068299:Salmeterol Xinafoate; D013440:Sulfides
D000085:Acetates; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; C093875:montelukast; D000420:Albuterol