OBJECTIVE: To explore the optimal doses of inhaled corticosteroids (ICS) for the management of Chinese asthmatics in order to enhance cost-effectiveness. METHODS: A randomized, paralleled and controlled multi-center study was carried out in 11 provincial hospitals. After one week run-in period when only inhaled salbutamol as needed was given, the asthmatic patients (n = 86) were divided into two groups: patients in group G (n = 42) received inhaled ICS with the doses recommended by Global Initiative for Asthma (GINA), ie, fluticasone propionate (FP) 250 microg bid for moderate asthma and 375 microg bid for severe asthma. Patients in group H (n = 44) received half of the above doses of FP (125 microg bid for moderate asthma and 125 microg in the morning, 250 microg in the evening for severe asthma). RESULTS: There were no significant differences between group G and group H in the 32 measurements after management, including day symptom score (severe asthma in group G 0.7 +/- 0.8, group H 0.4 +/- 0.6 and moderate asthma in group G 0.4 +/- 0.5, group H 0.3 +/- 0.5), FEV(1) [severe asthma in group G (1.5 +/- 0.5) L, group H (1.8 +/- 0.6) L/min and moderate asthma in group G (2.3 +/- 0.6) L, group H (2.3 +/- 0.8) L/min, FEV(1)% of predicted [severe asthma in group G (54 +/- 17)%, group H (59 +/- 19)%, and moderate asthma in group G (79 +/- 14)%, group H (79 +/- 15)%], the increased morning PEF value (45, 67 L/min in moderate and severe asthma in group G and 56, 65 L/min in moderate and severe asthma in group H respectively), frequency of nights awakened (81, 69 in severe asthma in groups G and H respectively), numbers of well controlled cases (88 and 98 d in severe asthma in groups G and H respectively) and the use of extra bronchodilators (salbutamol, puff/day, 5.0 and 3.4 d in severe asthma in groups G and H respectively, P > 0.05). On the other hand, in the subgroups of moderate asthma, night symptom score (0.30 +/- 0.22 in group G, 0.13 +/- 0.33, t = -2.06, P < 0.05), number of exacerbations (3/22 in group G, 11/24 in group H, chi(2) = 4.74, P < 0.05), number of total controlled cases (18/22 cases in group G, 12/24 cases in group H, chi(2) = 4.97, P < 0.05) were significantly different between group G and group H. In the subgroups of severe asthma, the total days of exacerbations were different between group G and group H (11 days in group G, 6 days in group H, U = 31, P < 0.05). CONCLUSION: As a whole, similar therapeutic effect was achieved using half of the GINA recommended dose of ICS with/without salbutamol inhalation as needed compared with those receiving the GINA recommended full dose of ICS in most Chinese asthmatics.
RCT Entities:
OBJECTIVE: To explore the optimal doses of inhaled corticosteroids (ICS) for the management of Chinese asthmatics in order to enhance cost-effectiveness. METHODS: A randomized, paralleled and controlled multi-center study was carried out in 11 provincial hospitals. After one week run-in period when only inhaled salbutamol as needed was given, the asthmatic patients (n = 86) were divided into two groups: patients in group G (n = 42) received inhaled ICS with the doses recommended by Global Initiative for Asthma (GINA), ie, fluticasone propionate (FP) 250 microg bid for moderate asthma and 375 microg bid for severe asthma. Patients in group H (n = 44) received half of the above doses of FP (125 microg bid for moderate asthma and 125 microg in the morning, 250 microg in the evening for severe asthma). RESULTS: There were no significant differences between group G and group H in the 32 measurements after management, including day symptom score (severe asthma in group G 0.7 +/- 0.8, group H 0.4 +/- 0.6 and moderate asthma in group G 0.4 +/- 0.5, group H 0.3 +/- 0.5), FEV(1) [severe asthma in group G (1.5 +/- 0.5) L, group H (1.8 +/- 0.6) L/min and moderate asthma in group G (2.3 +/- 0.6) L, group H (2.3 +/- 0.8) L/min, FEV(1)% of predicted [severe asthma in group G (54 +/- 17)%, group H (59 +/- 19)%, and moderate asthma in group G (79 +/- 14)%, group H (79 +/- 15)%], the increased morning PEF value (45, 67 L/min in moderate and severe asthma in group G and 56, 65 L/min in moderate and severe asthma in group H respectively), frequency of nights awakened (81, 69 in severe asthma in groups G and H respectively), numbers of well controlled cases (88 and 98 d in severe asthma in groups G and H respectively) and the use of extra bronchodilators (salbutamol, puff/day, 5.0 and 3.4 d in severe asthma in groups G and H respectively, P > 0.05). On the other hand, in the subgroups of moderate asthma, night symptom score (0.30 +/- 0.22 in group G, 0.13 +/- 0.33, t = -2.06, P < 0.05), number of exacerbations (3/22 in group G, 11/24 in group H, chi(2) = 4.74, P < 0.05), number of total controlled cases (18/22 cases in group G, 12/24 cases in group H, chi(2) = 4.97, P < 0.05) were significantly different between group G and group H. In the subgroups of severe asthma, the total days of exacerbations were different between group G and group H (11 days in group G, 6 days in group H, U = 31, P < 0.05). CONCLUSION: As a whole, similar therapeutic effect was achieved using half of the GINA recommended dose of ICS with/without salbutamol inhalation as needed compared with those receiving the GINA recommended full dose of ICS in most Chinese asthmatics.