BARCELONA, November 16, 2011 /PRNewswire/ --
- Almirall's respiratory franchise continues to expand in COPD - Clinical trials of the double bronchodilator combination have commenced to satisfy European and North American regulatory requirements
Almirall, S.A. (ALM.MC) today announced that, together with its US partner Forest, initiated a Phase III clinical programme of the fixed dose combination (FDC) of aclidinium bromide and formoterol fumarate twice daily (BID) delivered in the Genuair(R) inhaler, for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).
The Phase III programme involves approximately 3,500 patients with moderate to severe COPD and consists of two large pivotal studies -one conducted mainly in Europe and another in North America- evaluating the efficacy and safety of the FDC of aclidinium plus formoterol during 24 weeks, as well as a long-term safety study of 52 weeks which is also performed in North America. Protocols of these clinical trials have been designed to fulfil both EMA and FDA requirements.
The studies' endpoints include bronchodilation parameters (i.e. FEV1), symptom measurement (i.e. breathlessness assessed by Transition Dyspnoea Index -TDI-), health status (ie quality of life assessed by the St George's Respiratory Questionnaire -SGRQ-) and COPD exacerbations.
"After the filing of aclidinium monotherapy in Europe and the USA, the start of this global Phase III programme of the fixed dose combination of aclidinium and formoterol, in more than 25 countries, means that Almirall is progressing in expanding the aclidinium franchise. We are aiming to provide innovative treatment options for patients suffering from debilitating respiratory diseases, as is the case of COPD," said Bertil Lindmark, Chief Scientific Officer at Almirall.
In January, Almirall and Forest announced positive results of two Phase IIb dose-ranging studies comparing fixed-dose combinations to aclidinium bromide, formoterol and placebo, administered BID in patients with stable moderate to severe COPD patients. In both studies, the fixed dose combination demonstrated improved bronchodilation compared to aclidinium and formoterol alone.
Endpoint Definitions
FEV1 - Forced expiratory volume in one second, or the amount of air that can be exhaled in the first second, after an inhalation.
TDI - Multidimensional clinical instruments were developed by experts in order to provide a more comprehensive assessment of the severity of dyspnoea. The most widely used multidimensional instruments include the Transition Dyspnea Indices (TDI), which consider three components: functional impairment, magnitude of task, and magnitude of effort,
SGRG - The SGRQ is a 50-item questionnaire which measures health status (quality of life) in patients with diseases of airways obstruction. Scores are calculated for three domains: symptoms, activity and impacts (psycho-social) as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing.
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