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| | Top line results of first one-year COPD study with Daxas |
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date: Jul 22nd 2005 12:45
Following the announcement of the termination of the Daxas® roflumilast collaboration with Pfizer, ALTANA NYSE: AAA, FSE: ALT discloses today the top line results of the first one-year COPD study of Daxas®.
The phosphodiesterase4 PDE4- -inhibitor Daxas® is an oral investigational, steroid free anti-inflammatory agent being studied for the treatment of chronic obstructive pulmonary disease COPD and asthma.
In the COPD study “RATIO M2-112” the primary endpoint of lung function FEV1 significantly improved with roflumilast treatment compared to placebo. Treatment with roflumilast was associated with 39 + 12 ml endpoint analysis p=0.0005 and 48 + 9 ml difference from placebo using a full longitudinal data analysis respectively p<0.0001 . The study included 1,513 patients with severe and very severe COPD. The improvement in lung function was sustained over a one-year period.
The frequency of moderate and severe exacerbations was a co-primary endpoint. There was no statistically significant reduction in the rate of total exacerbations 7% reduction . The predefined secondary analysis of moderate exacerbations as requiring treatment with oral corticosteroids showed that roflumilast significantly reduced exacerbations by 18% p=0.0147 .
The most common adverse events associated with roflumilast treatment were nausea, headache and diarrhea.
After the termination of the Daxas® collaboration with Pfizer ALTANA will continue the development of Daxas®. A marketing authorization application MAA for Daxas® is under evaluation by regulatory agencies in Europe.
article 'Top line results of first one-year COPD study with Daxas' source is Altana Pharma AG, visit source site:
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