A phase III, randomized, parallel group study to compare the therapeutic efficacy of SMB BUDESONIDE-SALMETEROL DPI capsule 300/25microg BID delivered by the AXAHALER versus SERETIDE DISKUS 500/50microg (Fluticasone propionate 500microg/Salmeterol 50microg) BID over 12 weeks and to evaluate the safety of SMB BUDESONIDE-SALMETEROL 300/25microg over an additional period of 12 weeks in moderate to severe persistent asthmatic patients.

Trial Profile

A phase III, randomized, parallel group study to compare the therapeutic efficacy of SMB BUDESONIDE-SALMETEROL DPI capsule 300/25microg BID delivered by the AXAHALER versus SERETIDE DISKUS 500/50microg (Fluticasone propionate 500microg/Salmeterol 50microg) BID over 12 weeks and to evaluate the safety of SMB BUDESONIDE-SALMETEROL 300/25microg over an additional period of 12 weeks in moderate to severe persistent asthmatic patients.

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2011

At a glance

  • Drugs Budesonide/salmeterol; Salmeterol/fluticasone propionate
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms BUSAL
  • Most Recent Events

    • 29 Jun 2011 New trial record
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