317 (Po) Efficacy Of Roflumilast In The Treatment Of Asthma

Conference: 
Author(s): 
J.L. Izquierdo1, J. Bousquet2, M. Aubier3, F. Cerasoli4, C. Schmid-Wirlitsch5, A. Albrecht5
1Hospital General Universitario de Guadalajara, Guadalajara, Spain,
2H“pital Arnaud de Villeneuve, Montpellier, France,
3H“pital Bichat, Paris, France,
4 ALTANA Pharma AG, Florham Park, NJ, USA,
5 ALTANA Pharma AG, Konstanz, Germany
Text: 
BACKGROUND/AIM:
In asthma, inhaled corticosteroids currently represent the standard for treating the underlying inflammatory disease.
Phosphodiesterase 4 (PDE4) inhibitors are new therapeutic agents that target key inflammatory processes in asthma. We studied the effects of roflumilast, an investigational, oral, once-daily PDE4 inhibitor, in asthma patients and compared the treatment of inhaled beclomethasone dipropionate (BDP) with oral roflumilast.
METHODS:
Two randomized, double-blind 12-week studies in patients with stable asthma were conducted. In a dose-range finding study with a single-blind placebo run-in period of 1-3 weeks, 690 patients received oral roflumilast 100æg, 250æg or 500æg once daily. In an active-control study, 421 patients received either oral roflumilast 500æg once daily or inhaled BDP 200æg twice daily. Improvement in lung function was assessed by spirometry (change in forced expiratory volume in one second [FEV1]) from baseline. Asthma symptom scores, rescue medication use, and safety and tolerability parameters were evaluated.
RESULTS:
In both studies, roflumilast significantly increased lung function (FEV1) from baseline (pCONCLUSIONS:
Oral, once-daily roflumilast significantly improved lung function in patients with stable asthma. Oral, once-daily roflumilast 500æg was comparable with inhaled, twice-daily BDP 200æg (400æg/d) in improving FEV1 and asthma symptoms. Funded by ALTANA Pharma AG.
Literature: 
317 (PO) EFFICACY OF ROFLUMILAST IN THE TREATMENT OF ASTHMA