Clinical Trial: Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid

Brief Summary: A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Clinical failure at 8 weeks post therapy [ Time Frame: At day 63 ]

Original Primary Outcome: The primary efficacy variable is clinical failure at 8 weeks post therapy. [ Time Frame: 18 months ]

Current Secondary Outcome:

  • Clinical failure rates [ Time Frame: Through to day 35 ]
  • Bacteriological eradication rates [ Time Frame: Through to day 63 ]
  • Clinical failure rates for subjects with positive sputum culture at enrollment [ Time Frame: Through to day 63 ]
  • Weekly mean symptom scores measured by the AECB SS [ Time Frame: Through to day 63 ]
  • Rates and speed of symptom relief measured by the AECB SS [ Time Frame: Through to day 63 ]
  • Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1) [ Time Frame: Through to day 63 ]
  • Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2) [ Time Frame: Through to day 63 ]
  • Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilators [ Time Frame: Through to day 63 ]
  • Improvement in symptoms burden measured by the AECB SS [ Time Frame: Through to day 63 ]
  • Improvement in health related QoL measured by the SGRQ [ Time Frame: Through to day 63 ]
  • spirometry tests will be compared between treatment groups [ Time Frame: Through to day 63 ]
  • HCRU relat. to chronic bronchitis management incl. rescue med., concomitant med., therap. adjuncts, diagn. procedures, other medical care/medical staff requirement, hospitalizations (incl. ward and duration), and work productivity and activity impairment [ Time Frame: Through to day 63 ]
  • Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea [ Time Frame: Through to day 63 ]


Original Secondary Outcome:

  • The secondary efficacy variables are:- clinical efficacy rates at the During Therapy, EOT, and 4 weeks Post therapy [ Time Frame: 18 months ]
  • Bacteriological eradication rates at During Therapy, EOT, 4 weeks Post therapy, and 8 weeks Post therapy visits [ Time Frame: 18 months ]
  • Clinical efficacy rates for subjects with positive sputum culture at enrollment at the During Therapy, EOT, 4 weeks Post therapy, and 8 weeks Post therapy visits [ Time Frame: 18 months ]
  • Weekly mean symptom scores measured by the AECB SS [ Time Frame: 18 months ]
  • Rates and speed of symptom relief measured by the AECB SS [ Time Frame: 18 months ]
  • Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilators [ Time Frame: 18 months ]
  • Improvement in symptoms burden measured by the AECB SS [ Time Frame: 18 months ]
  • Improvement in health related QoL measured by the SGRQ [ Time Frame: 18 months ]
  • Lung function test will be compared between treatment groups at each assessment visit [ Time Frame: 18 months ]
  • HCRU related to chronic bronchitis management including rescue medications, concomitant medications, therapeutic adjuncts, diagnostic procedures, [ Time Frame: 18 months ]
  • Other medical care/medical staff requirement, hospitalizations (including ward and duration), and work productivity and activity impairment [ Time Frame: 18 months ]
  • Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea [ Time Frame: 18 months ]


Information By: Bayer

Dates:
Date Received: April 4, 2008
Date Started: March 2008
Date Completion:
Last Updated: November 27, 2014
Last Verified: November 2014