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Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: the Pediatric Asthma
Christine A Sorkness1, Robert F Lemanske, David T Mauger
1Clinical Science Center, University of Wisconsin, Madison, WI 53792, USA. Sorkness@facstaff.wisc.edu
Insights
Fluticasone monotherapy and a combination therapy improved asthma control in children more than montelukast. Fluticasone monotherapy showed superior results in other asthma control measures.
Area of Science:
- Pediatric pulmonology
- Asthma management
- Clinical trials
Background:
- Evidence is needed for optimal treatment of mild-moderate persistent asthma in school-aged children.
- The Pediatric Asthma Controller Trial (PACT) aimed to address this gap.
Purpose of the Study:
- To compare the effectiveness of three asthma treatment regimens in achieving asthma control in children.
- To evaluate fluticasone monotherapy, a fluticasone/salmeterol combination, and montelukast.
Main Methods:
- 285 children (6-14 years) with mild-moderate persistent asthma were randomized into three 48-week treatment groups.
- Treatments included fluticasone monotherapy, a fluticasone/salmeterol combination (PACT combination), and montelukast.
- Outcomes assessed were asthma control days, exacerbations, and pulmonary function.
Main Results:
- Fluticasone monotherapy and PACT combination showed comparable asthma control days.
- Fluticasone monotherapy was superior in clinic-measured FEV1/FVC, bronchodilator response, exhaled nitric oxide, and PC20.
- Fluticasone monotherapy outperformed montelukast in asthma control days and other control outcomes.
Conclusions:
- Both fluticasone monotherapy and PACT combination improved asthma control days more than montelukast.
- Fluticasone monotherapy demonstrated superiority over PACT combination in other asthma control dimensions.
- Growth was similar across all treatment groups, supporting fluticasone monotherapy as a preferred option.
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)
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.
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