Chronotherapy with modified release prednisone improves nocturnal asthma
L. Alavoine, C. Knauer, S. Witte, M. Aubier (Paris, France; Mannheim, Germany)
Source: Annual Congress 2010 - New treatments for asthma and COPD
Session: New treatments for asthma and COPD
Session type: Thematic Poster Session
Number: 1173
Disease area: Airway diseases
Abstract A novel modified release prednisone tablet (MRT) allows the overnight synchronization of drug release to both, the circadian rhythm of endogenous cortisol, and disease symptoms. Recent data in rheumatoid arthritis demonstrated superior improvement in morning symptoms for MRT, with comparable safety to immediate release (IR) prednisone. The objective of this study was to evaluate if MRT can provide superior asthma control, in patients with nocturnal asthma, than the identical dose of IR prednisone. In a 2 phase open study, patients with severe nocturnal asthma, are administered IR prednisone at 8 AM for 4 weeks, then switched to overnight administration (10PM) of the same dose of MRT for another 4 weeks. The primary endpoint is number of nocturnal awakenings due to asthma. Secondary endpoints include asthma control questionnaire (ACQ), asthma quality of life questionnaire (AQLQ) and general safety. Data from five patients, treated daily with prednisone (5-45 mg/day) showed clinically relevant improvements in nocturnal symptoms, ACQ and AQLQ. The number of nocturnal awakenings, due to asthma, changed from 9.2 ± 6.3 to 2.6 ± 5.3 and the number of salbutamol inhalations per day decreased from 2.1 (1.4-3.3) to 1 (0.1-4.2), comparing IR prednisone and MRT in the last two weeks of respective treatment. ACQ6 improved from 3.2 to 2.0, as well as AQLQ from 3.9 to 4.9 after the switch from IR prednisone to MRT. The incidence of adverse events was low throughout the study. Preliminary data show that chronotherapy with MRT improves asthma control and may improve the benefit-risk ratio of prednisone treatment.
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L. Alavoine, C. Knauer, S. Witte, M. Aubier (Paris, France; Mannheim, Germany). Chronotherapy with modified release prednisone improves nocturnal asthma. Eur Respir J 2010; 36: Suppl. 54, 1173
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