Purpose: To evaluate asthma control in patients switched from a fixed dose of beclomethasone (BDP) or triamcinolone (TAA) to low-dose fluticasone propionate (FP) or zafirlukast (ZAF).
Methods: Patients (males and females [is greater than or equal to] 12 years of age, [FEV.sub.1] = 60 to 85% of predicted normal) using a fixed dose of BDP (168 to 336 mcg/day) or TAA (400 to 800 mcg/day) for [is greater than or equal to] 4 weeks were randomized to FP aerosol (88mcg BID) or ZAF (20mg BID) for 6 weeks using a double-blind, double-dummy, parallel-group design. Clinic [FEV.sub.1] measurements and daily PEF, asthma symptoms, albuterol use, and adverse events were collected.
Results: Treatment with FP resulted in significantly greater improvements in measures of pulmonary function and symptom control as compared to ZAF. At endpoint, rescue albuterol use decreased with FP and increased with ZAF (P [is less than] 0.001). Significantly fewer (P=0.006) asthma exacerbations occurred with FP (n=2) as compared to ZAF (n= 12) and withdrawals due to lack of efficacy were reported for 5 (2%) FP patients and 29 (13%) ZAF patients. Adverse event profiles were similar.
(*) P<0.001 vs. ZAF
Conclusion: Switching patients from BDP or TAA to FP resulted in greater improvements in measures of pulmonary function and symptom control compared to ZAF.
Clinical Implications: For patients with stable, persistent asthma who are taking low doses of ICS, switching to a low-dose of FP may result in improved asthma control, while switching to ZAF monotherapy may result in reduced asthma control.
Grant Support by: Glaxo Wellcome Inc.
Kathleen A Rickard, MD(*); P Pepsin, RN; S Srebro, MD; L Edwards, PhD and FP Study Group. Medical Affairs, Glaxo Wellcome Inc, Research Triangle Park, NC.3
COPYRIGHT 1999 American College of Chest Physicians
COPYRIGHT 2000 Gale Group