Greatest International Antiinfective Trial With Avelox

Bronchitis, Chronic Clinical Trial

— GIANT  

Official title:

GIANT - Greatest International Antiinfective Trial With Avelox®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932802
• Other study ID #: 12219
• Secondary ID: AX04011182812206
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: November 16, 2012
• Start date: February 2004
• Est. completion date: November 2007

Study information

• Verified date: November 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50000
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchial Diseases
• Bronchitis
• Bronchitis, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Brazil,  China,  Colombia,  Croatia,  Egypt,  El Salvador,  Germany,  Hong Kong,  Hungary,  Indonesia,  Korea, Republic of,  Malaysia,  Mexico,  Morocco,  Netherlands,  Pakistan,  Philippines,  Poland,  Singapore,  Slovenia,  Switzerland,  Taiwan,  Turkey, 

References & Publications (1)

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		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).	Yes
Secondary	Course of symptom relief		During documentation of up to two short-term follow-up visits (within ca. 14 days)	No
Secondary	Speed of return to normal daily life activities		During documentation of the last short-term follow-up visit (after ca. 14 days)	No
Secondary	Adverse events collection		Throughout the entire study, whenever Adverse Events occur	Yes
Secondary	Evaluation of frequency of new exacerbations		During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)	No
Secondary	Progression of chronic respiratory disease		During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)	No

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