Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2007 Jan;119(1):64-72.
doi: 10.1016/j.jaci.2006.09.042. Epub 2006 Nov 30.

Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: the Pediatric Asthma Controller Trial

Christine A Sorkness  1 , Robert F Lemanske Jr, David T Mauger, Susan J Boehmer, Vernon M Chinchilli, Fernando D Martinez, Robert C Strunk, Stanley J Szefler, Robert S Zeiger, Leonard B Bacharier, Gordon R Bloomberg, Ronina A Covar, Theresa W Guilbert, Gregory Heldt, Gary Larsen, Michael H Mellon, Wayne J Morgan, Mark H Moss, Joseph D Spahn, Lynn M Taussig; Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute
Affiliations
Randomized Controlled Trial

Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: the Pediatric Asthma Controller Trial

Christine A Sorkness et al. J Allergy Clin Immunol. 2007 Jan.

Erratum in

  • J Allergy Clin Immunol. 2007 Aug;120(2):285

Abstract

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).

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 FEV(1) >or= 80% predicted, confirming current guideline recommendations.

PubMed Disclaimer

Publication types