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KMID : 0378019970400060044
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New Medical Journal
1997 Volume.40 No. 6 p.44 ~ p.54
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Clinical Efficacy & Safety of Fluticasone Propionate(Flixotide^(®)) in the Treatment of Patients with Asthma
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Abstract
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Asthma has been recognized to be a chronic inflammatory disease. Corticosteroids are the most effective antiinflammatory drugs for the treatment of asthma. Inhaled corticosteroids have become the first-line therapy for the treatment of all stages of asthma due to their direct effect on target organ. Recently, Fluticasone Propionate as a new inhaled corticosteroid with a potent topical activity and minimal side effects has been developed.
Objectives : The purpose of this study was to assess the efficacy and safety of Fluticasone Propionate aerosol in the treatment of asthma.
Method : Thirty patients with asthma took part in this study. Five patients were excluded due to poor compliance. All of the patients had stable asthma under their medications and nine patients had demonstrated reversibility in FEV, to inhaled salbutamol of at least 15% after 200ug or 20% after 400us. Patients receiving treatment with oral antiasthmatic drug except steroids retained these medications unchanged through the study. Fluticasone Propionate aerosol 250ug twice daily was given for 4 weeks to asthmatic patients. We com-pared daily symptom score, peak expiratory flow rate(PEFR) and its diurnal variability, the fraction of days of additional bronchodilator required to relieve asthma symptoms, and FEV, between period of run-in and treatment.
Results
1. Mean morning and night PEFR significantly improved following Fluticasone Propionate(Flixotide, FP) treatment(412.9 ± 21.3, 429.5 ± 21.6 L/min in the 2 weeks and 4 weeks treatment period vs 356.0 ± 19.2LJmin run-in period; 422.9 ± 21.4, 440.5 ± 22.2 Umin in the 2 weeks and 4 Weeks treatment period vs 393.9 ± 22.0 Umin run-in period).
Diurnal variability of PEFR significantly reduced during 2 weeks and 4 weeks treat-ment period respectively(3.56 ± 0.76%, 3.76 ± 0.93%) compared with run-in period(22.5 ± 2.5%).
2. Mean forced expiratory volume in 1 second(FEV,) improved after 2 weeks and 4 weeks FP treatment compared with run-in period(87.7 ± 3.8%, 87.4 ± 3.8% pred. after treatment vs 75.8 ± 2.7% pred. before treatment, p<0.01).
3. Mean daytime symptom scores after 2 weeks and 4 weeks more significantly declined after treatment than run-in period (0.20±0.06, 0.14±0.06 vs 0.44 ± 0.07). Mean nighttime symptom scores more significantly declined after 2 weeks and 4 weeks treatment than run-in period (0.11 ±0.06,0.20±0.05 vs 0.53± 0.12)(p<0.01).
4: The fraction´ of days required for salbutamol use to treat day symptoms significantly decreased in the four weeks treatment compared with run-in period(85.9±6.3% vs 62.4± 7.6%). The fraction of nights required for salbutamol use to treat night symp-toms significantly decreased in the two and four weeks treatment compared with running period(92.2 ± 4.24, 86.9±4.2% vs 71.3 ± 6:3%).
5. No significant differences between run-in and treatment period were observed in blood pressure, pulse rate, other laboratory examinations and there were few adverse events including nausea, throat discomfort, voice change during FP treatment.
Conclusion : This study suggests that Fluticasone Propionate(Flixotide®) at a dosage 500 pg/day by metered dose inhaler(MDI) provide effective and safe treatment for asthma.
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