Clinical trial NCT00932802: Greatest International Antiinfective Trial With Avelox
Official title: GIANT - Greatest International Antiinfective Trial With Avelox®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchitis, Chronic
Bronchial Diseases
Keywords: Non-Interventional
Observational
NIS
Moxifloxacin
MXF
Avelox
AECB
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 50000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of AECB who take moxifloxacin

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 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 outcomes:
measure: Course of symptom relief
timeFrame: During documentation of up to two short-term follow-up visits (within ca. 14 days)
measure: Speed of return to normal daily life activities
timeFrame: During documentation of the last short-term follow-up visit (after ca. 14 days)
measure: Adverse events collection
timeFrame: Throughout the entire study, whenever Adverse Events occur
measure: Evaluation of frequency of new exacerbations
timeFrame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
measure: Progression of chronic respiratory disease
timeFrame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Brazil
city: Many Locations
country: China
city: Many Locations
country: Colombia
city: Many Locations
country: Croatia
city: Many Locations
country: Egypt
city: Many Locations
country: El Salvador
city: Many Locations
country: Germany
city: Many Locations
country: Hong Kong
city: Many Locations
country: Hungary
city: Many Locations
country: Indonesia
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Malaysia
city: Many Locations
country: Mexico
city: Many Locations
country: Morocco
city: Many Locations
country: Netherlands
city: Many Locations
country: Pakistan
city: Many Locations
country: Philippines
city: Many Locations
country: Poland
city: Many Locations
country: Singapore
city: Many Locations
country: Slovenia
city: Many Locations
country: Switzerland
city: Many Locations
country: Taiwan
city: Many Locations
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.