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A 48-WEEK, DOUBLE BLIND, RANDOMIZED, MULTINATIONAL, MULTICENTRE, 2-ARM PARALLEL GROUP, REFERENCE TREATMENT CONTROLLED CLINICAL TRIAL OF “FIXED COMBINATION” BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-012546-23

A 48-WEEK, DOUBLE BLIND, RANDOMIZED, MULTINATIONAL, MULTICENTRE, 2-ARM PARALLEL GROUP, REFERENCE TREATMENT CONTROLLED CLINICAL TRIAL OF “FIXED COMBINATION” BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA pMDI (CHF 1535 FOSTER®) VERSUS FORMOTEROL IN PATIENTS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Femme et Homme

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Extrait

To demonstrate that CHF 1535 twice daily is superior to Formoterol twice daily in terms of COPD exacerbations rate after 48 weeks of treatment and in terms of pulmonary function (change in pre-dose morning FEV1 from baseline to 12 weeks) in patients with severe COPD.

Critère d'inclusion

  • Severe Chronic Obstructive Pulmonary Disease (COPD)

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