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Comparison of roflumilast, an oral anti‐inflammatory, with beclomethasone dipropionate in the treatment of persistent asthma
Author(s) -
Bousquet J.,
Aubier M.,
Sastre J.,
Izquierdo J. L.,
Adler L. M.,
Hofbauer P.,
Rost K.D.,
Harnest U.,
Kroemer B.,
Albrecht A.,
Bredenbröker D.
Publication year - 2006
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/j.1398-9995.2005.00931.x
Subject(s) - roflumilast , medicine , asthma , adverse effect , beclometasone dipropionate , anesthesia , pulmonary function testing , vital capacity , lung function , respiratory disease , lung , copd , diffusing capacity
Background: Roflumilast is an oral, once‐daily phosphodiesterase 4 inhibitor with anti‐inflammatory activity in development for the treatment of asthma. Roflumilast was compared with inhaled beclomethasone dipropionate (BDP) in patients with asthma. Methods: In a double blind, double‐dummy, randomized, noninferiority study, 499 patients (forced expiratory volume in 1 s [FEV 1 ] = 50–85% predicted) received roflumilast 500 μ g once daily or BDP 200 μ g twice daily (400 μ g/day) for 12 weeks. Lung function and adverse events were monitored. Results: Roflumilast and BDP significantly improved FEV 1 by 12% (270 ± 30 ml) and 14% (320 ± 30 ml), respectively ( P < 0.0001 vs baseline). Roflumilast and BDP also significantly improved forced vital capacity (FVC) ( P < 0.0001 vs baseline). There were no significant differences between roflumilast and BDP with regard to improvement in FEV 1 and FVC. Roflumilast and BDP showed small improvements in median asthma symptom scores (–0.82 and −1.00, respectively) and reduced rescue medication use (−1.00 and −1.15 median puffs/day, respectively; P < 0.0001 vs baseline). These small differences between roflumilast and BDP were not considered clinically relevant. Both agents were well tolerated. Conclusions: Once daily, oral roflumilast 500 μ g was comparable with inhaled twice‐daily BDP (400 μ g/day) in improving pulmonary function and asthma symptoms, and reducing rescue medication use in patients with asthma.