Abstract
Background: With the transition to hydrofluoroalkane-134a propellants in metered dose inhalers, it is
important to consider the efficacy and safety profiles of formulations containing inhaled corticosteroids.
We examined the airway and systemic effects of hydrofluoroalkane-134a fluticasone propionate (FLUHFA)
and beclomethasone dipropionate (BEC-HFA) at recommended labelled doses.
Methods: Twenty mild to moderate asthmatics were randomised in crossover fashion to receive 6
weeks of 500 µg/day followed by 1000 µg/day FLU-HFA and BEC-HFA. Measurements were made
at baseline after placebo run in and washout, and after each randomised treatment. The primary airway
outcome for benefit was the dose of methacholine provoking a fall in forced expiratory volume in
1 second (FEV1) of 20% or more (methacholine PD20) and for systemic adverse effects was overnight urinary
cortisol/creatinine (OUCC).
Results: For mean responses, both doses of BEC-HFA and FLU-HFA produced significant improvements
in PD20 compared with baseline. The improvement was not significantly greater with 1000 µg/day
FLU-HFA versus BEC-HFA, a 1.69 fold difference (95% CI 0.94 to 3.04). Both doses of BEC-HFA but
not FLU-HFA caused significant suppression of OUCC compared with baseline, with significantly
(p<0.05) lower values at 1000 µg/day for BEC-HFA versus FLU-HFA (1.97 fold difference (95% CI
1.28 to 3.02)).
Conclusion: There was no difference in the airway and systemic effects in patients with mild to moderate
asthma between FLU-HFA and BEC-HFA at a dose of 500 µg/day. At 1000 µg/day there was
increased systemic bioactivity with BEC-HFA compared with FLU-HFA, without any gain in airway efficacy.
important to consider the efficacy and safety profiles of formulations containing inhaled corticosteroids.
We examined the airway and systemic effects of hydrofluoroalkane-134a fluticasone propionate (FLUHFA)
and beclomethasone dipropionate (BEC-HFA) at recommended labelled doses.
Methods: Twenty mild to moderate asthmatics were randomised in crossover fashion to receive 6
weeks of 500 µg/day followed by 1000 µg/day FLU-HFA and BEC-HFA. Measurements were made
at baseline after placebo run in and washout, and after each randomised treatment. The primary airway
outcome for benefit was the dose of methacholine provoking a fall in forced expiratory volume in
1 second (FEV1) of 20% or more (methacholine PD20) and for systemic adverse effects was overnight urinary
cortisol/creatinine (OUCC).
Results: For mean responses, both doses of BEC-HFA and FLU-HFA produced significant improvements
in PD20 compared with baseline. The improvement was not significantly greater with 1000 µg/day
FLU-HFA versus BEC-HFA, a 1.69 fold difference (95% CI 0.94 to 3.04). Both doses of BEC-HFA but
not FLU-HFA caused significant suppression of OUCC compared with baseline, with significantly
(p<0.05) lower values at 1000 µg/day for BEC-HFA versus FLU-HFA (1.97 fold difference (95% CI
1.28 to 3.02)).
Conclusion: There was no difference in the airway and systemic effects in patients with mild to moderate
asthma between FLU-HFA and BEC-HFA at a dose of 500 µg/day. At 1000 µg/day there was
increased systemic bioactivity with BEC-HFA compared with FLU-HFA, without any gain in airway efficacy.
Original language | English |
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Pages (from-to) | 865-8 |
Number of pages | 4 |
Journal | Thorax |
Volume | 57 |
Issue number | 10 |
DOIs | |
Publication status | Published - 2002 |