TY - JOUR
T1 - Safety of hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol
AU - Thompson, P. J.
AU - Davies, R. J.
AU - Young, W. F.
AU - Grossman, A. B.
AU - Donnell, D.
N1 - Funding Information:
Inhaled corticosteroids are widely used as first-line preventative therapy in asthma (1) and are recommended as such in the Global Initiative for Asthma treatment guidelines (2), in the British Thoracic Society guidelines (3) and by the National Asthma Campaign in Australia (4). Various drugs are available, but beclomethasone dipropionate (BDP), which was among the first to be introduced, is still the most widely prescribed. It has been extensively used for the Correspondence should be addressed to: D. Donnell, 3M Pharmaceuticals, 3M House, Morley Street, Lough-borough, Leicestershire LEl 1 lEP, U.K. This supplement was sponsored by 3M Pharmaceuticals.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 1998/6
Y1 - 1998/6
N2 - Herein we assess the safety of an inhaled formulation of beclomethasone dipropionate (BDP) which uses the propellant hydrofluoroalkane-134a (HFA) for the treatment of asthma. Acute local tolerability (as assessed by the incidence of cough and mean forced expiratory volume after 1 s inhalation) was similar for both BDP and placebo formulated in either chlorofluorocarbon (CFC) or HFA propellants. A total of 43 patients were treated with HFA-BDP (0, 200, 400 or 800 μg day-1) or CFC-BDP (800 μg day-1) for 14 days and their 24 h urinary free cortisol (UFC) excretion and response to cosyntropin stimulation were measured. There was no difference in UFC between any of the doses of HFA-BDP and CFC-BDP. Adrenal responsiveness to cosyntropin stimulation was normal in all but one patient. Two large 12 week phase III trials compared HFA-placebo, HFA-BDP 400 μg day-1 and CFC-BDP 800 μg day-1 (n = 347), and HFA-BDP 800 μg day-1 and CFC-BDP 1500 μg day-1 (n = 233). For HFA-BDP at either dose, CFC-BDP 800 μg day-1 and HFA-placebo, the number of patients with morning plasma cortisol concentrations below normal was less than 4.4% but was 14.6% for CFC-BDP 1500 μg day-1. The incidence of adverse events was lower in the HFA-BDP groups than in the CFC-BDP groups (P = 0.012). The data indicate that, at doses of up to 800 μg day-1, HFA-BDP is at least as well tolerated as CFC-BDP. Other studies have found that equivalent efficacy is reached at lower doses of HFA-BDP than CFC-BDP. Equivalent efficacy at a lower dose and equivalent safety at the same dose imply that HFA-BDP may have a more favourable risk:benefit ratio than CFC-BDP when used at the recommended lower doses.
AB - Herein we assess the safety of an inhaled formulation of beclomethasone dipropionate (BDP) which uses the propellant hydrofluoroalkane-134a (HFA) for the treatment of asthma. Acute local tolerability (as assessed by the incidence of cough and mean forced expiratory volume after 1 s inhalation) was similar for both BDP and placebo formulated in either chlorofluorocarbon (CFC) or HFA propellants. A total of 43 patients were treated with HFA-BDP (0, 200, 400 or 800 μg day-1) or CFC-BDP (800 μg day-1) for 14 days and their 24 h urinary free cortisol (UFC) excretion and response to cosyntropin stimulation were measured. There was no difference in UFC between any of the doses of HFA-BDP and CFC-BDP. Adrenal responsiveness to cosyntropin stimulation was normal in all but one patient. Two large 12 week phase III trials compared HFA-placebo, HFA-BDP 400 μg day-1 and CFC-BDP 800 μg day-1 (n = 347), and HFA-BDP 800 μg day-1 and CFC-BDP 1500 μg day-1 (n = 233). For HFA-BDP at either dose, CFC-BDP 800 μg day-1 and HFA-placebo, the number of patients with morning plasma cortisol concentrations below normal was less than 4.4% but was 14.6% for CFC-BDP 1500 μg day-1. The incidence of adverse events was lower in the HFA-BDP groups than in the CFC-BDP groups (P = 0.012). The data indicate that, at doses of up to 800 μg day-1, HFA-BDP is at least as well tolerated as CFC-BDP. Other studies have found that equivalent efficacy is reached at lower doses of HFA-BDP than CFC-BDP. Equivalent efficacy at a lower dose and equivalent safety at the same dose imply that HFA-BDP may have a more favourable risk:benefit ratio than CFC-BDP when used at the recommended lower doses.
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U2 - 10.1016/S0954-6111(98)90215-3
DO - 10.1016/S0954-6111(98)90215-3
M3 - Article
C2 - 9850361
AN - SCOPUS:0031901949
VL - 92
SP - 33
EP - 39
JO - British Journal of Tuberculosis and Diseases of the Chest
JF - British Journal of Tuberculosis and Diseases of the Chest
SN - 0954-6111
IS - SUPPL. A
ER -