Greatest International Antiinfective Trial With Avelox

Overview

The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.

Full Title of Study: “GIANT – Greatest International Antiinfective Trial With Avelox®”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2007

Interventions

  • Drug: Moxifloxacin (Avelox, BAY12-8039)
    • AECB patients under daily life treatment receiving moxifloxacin according to the local product information.

Arms, Groups and Cohorts

  • Group 1

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice
    • Time Frame: During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).

Secondary Measures

  • Course of symptom relief
    • Time Frame: During documentation of up to two short-term follow-up visits (within ca. 14 days)
  • Speed of return to normal daily life activities
    • Time Frame: During documentation of the last short-term follow-up visit (after ca. 14 days)
  • Adverse events collection
    • Time Frame: Throughout the entire study, whenever Adverse Events occur
  • Evaluation of frequency of new exacerbations
    • Time Frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
  • Progression of chronic respiratory disease
    • Time Frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)

Participating in This Clinical Trial

Inclusion Criteria

  • Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin Exclusion Criteria:

Exclusion criteria must be read in conjunction with the local product information

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Bayer Schering Pharma AG, Medical Affairs Therapeutic Area Head
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

Citations Reporting on Results

Anzueto A, Miravitlles M, Ewig S, Legnani D, Heldner S, Stauch K. Identifying patients at risk of late recovery (>/= 8 days) from acute exacerbation of chronic bronchitis and COPD. Respir Med. 2012 Sep;106(9):1258-67. doi: 10.1016/j.rmed.2012.06.002. Epub 2012 Jun 30.

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