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Comparison of combination inhalers vs inhaled corticosteroids alone in moderate persistent asthma
Author(s) -
Lee Daniel K. C.,
Jackson Catherine M.,
Currie Graeme P.,
Cockburn Wendy J.,
Lipworth Brian J.
Publication year - 2003
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1046/j.1365-2125.2003.01887.x
Subject(s) - fluticasone propionate , medicine , salbutamol , formoterol , asthma , salmeterol , methacholine , budesonide , corticosteroid , anesthesia , pulmonary function testing , inhalation , fluticasone , randomization , randomized controlled trial , respiratory disease , lung
Aims Inhalers combining long acting β 2 ‐adrenoceptor agonists (LABA) and corticosteroids (ICS) are indicated at Step 3 of current asthma guidelines. We evaluated the relative effects of LABA + ICS combination vs ICS alone on pulmonary function, bronchoprotection, acute salbutamol recovery following methacholine bronchial challenge, and surrogate inflammatory markers in patients with moderate persistent asthma. Methods Twenty‐nine patients with mean FEV 1 (± SEM) of 78 ± 3% predicted completed a randomized, double‐blind, double‐dummy, cross‐over study. Patients received either 4 weeks of budesonide 400 µg + formoterol 12 µg (BUD + FM) combination twice daily followed by 1 week of BUD 400 µg alone twice daily, or 4 weeks of fluticasone propionate 250 µg + salmeterol 50 µg (FP + SM) combination twice daily followed by 1 week of FP 250 µg alone twice daily. Measurements were made at baseline and following each randomized treatment. Results FEV 1 increase from pretreatment baseline as mean (± SEM) % predicted was significantly higher ( P < 0.05) for BUD + FM (8 ± 1%) vs BUD (2 ± 1%), and for FP + SM (8 ± 1%) vs FP (2 ± 1%). The fall in FEV 1 following methacholine challenge as percentage change from prechallenge baseline FEV 1 was not significantly different in all four groups; BUD + FM (22 ± 1%), BUD (24 ± 1%), FP + SM (23 ± 1%) and FP (23 ± 1%). Salbutamol recovery over 30 min following methacholine challenge as area under curve (AUC %.min) was significantly blunted ( P < 0.05) with BUD + FM (486.7 ± 35.5) vs BUD (281.1 ± 52.8), and with FP + SM (553.1 ± 34.1) vs FP (368.3 ± 46.7). There were no significant differences between respective combination inhalers or between respective ICS alone. Decreases in exhaled nitric oxide (NO) and serum eosinophilic cationic protein (ECP) from baseline were not significantly different between treatments. Conclusions Combination inhalers improve pulmonary function without potentiating anti‐inflammatory effects on exhaled NO and serum ECP as compared with ICS alone, but delay acute salbutamol recovery after bronchoconstriction.