Greatest International Antiinfective Trial With Avelox (GIANT)

• ClinicalTrials.gov Identifier: NCT00932802
• Recruitment Status: Completed
• First Posted: July 3, 2009
• Last Update Posted: November 19, 2012
• Sponsor: Bayer
• Information provided by: Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Bronchitis, Chronic; Bronchial Diseases	Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Design

• Study Type: Observational
• Actual Enrollment: 50000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: GIANT - Greatest International Antiinfective Trial With Avelox®
• Study Start Date: February 2004
• Actual Primary Completion Date: November 2007
• Actual Study Completion Date: November 2007

Groups and Cohorts

Group/Cohort	Intervention/treatment
Group 1	Drug: Moxifloxacin (Avelox, BAY12-8039); AECB patients under daily life treatment receiving moxifloxacin according to the local product information.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Course of symptom relief [ Time Frame: During documentation of up to two short-term follow-up visits (within ca. 14 days) ]
2. Speed of return to normal daily life activities [ Time Frame: During documentation of the last short-term follow-up visit (after ca. 14 days) ]
3. Adverse events collection [ Time Frame: Throughout the entire study, whenever Adverse Events occur ]
4. 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) ]
5. Progression of chronic respiratory disease [ Time Frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months) ]

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of AECB who take moxifloxacin

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

Contacts and Locations

Locations

Austria

Many Locations, Austria

Brazil

Many Locations, Brazil

China

Many Locations, China

Colombia

Many Locations, Colombia

Croatia

Many Locations, Croatia

Egypt

Many Locations, Egypt

El Salvador

Many Locations, El Salvador

Germany

Many Locations, Germany

Hong Kong

Many Locations, Hong Kong

Hungary

Many Locations, Hungary

Indonesia

Many Locations, Indonesia

Korea, Republic of

Many Locations, Korea, Republic of

Malaysia

Many Locations, Malaysia

Mexico

Many Locations, Mexico

Morocco

Many Locations, Morocco

Netherlands

Many Locations, Netherlands

Pakistan

Many Locations, Pakistan

Philippines

Many Locations, Philippines

Poland

Many Locations, Poland

Singapore

Many Locations, Singapore

Slovenia

Many Locations, Slovenia

Switzerland

Many Locations, Switzerland

Taiwan

Many Locations, Taiwan

Turkey

Many Locations, Turkey

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Publications of 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.

• Responsible Party: Bayer Schering Pharma AG, Medical Affairs Therapeutic Area Head
• ClinicalTrials.gov Identifier: NCT00932802
• Other Study ID Numbers: 12219; AX0401 ( Other Identifier: Company Internal ); 11828 ( Other Identifier: Company Internal ); 12206 ( Other Identifier: Company Internal ); 12214 ( Other Identifier: Company Internal ); 12234 ( Other Identifier: Company Internal ); 12213 ( Other Identifier: Company Internal ); 12212 ( Other Identifier: Company Internal ); 12216 ( Other Identifier: Company Internal ); 12220 ( Other Identifier: Company Internal ); 12219 ( Other Identifier: Company Internal ); 12217 ( Other Identifier: Company Internal ); 12225 ( Other Identifier: Company Internal ); 12223 ( Other Identifier: Company Internal ); 12229 ( Other Identifier: Company Internal ); 12221 ( Other Identifier: Company Internal ); 12218 ( Other Identifier: Company Internal ); 12222 ( Other Identifier: Company Internal ); 12230 ( Other Identifier: Company Internal ); 12211 ( Other Identifier: Company Internal ); 12227 ( Other Identifier: Company Internal ); 12228 ( Other Identifier: Company Internal ); 12226 ( Other Identifier: Company Internal ); 12235 ( Other Identifier: Company Internal ); 12233 ( Other Identifier: Company Internal ); 12224 ( Other Identifier: Company Internal ); 12215 ( Other Identifier: Company Internal ); 12231 ( Other Identifier: Company Internal ); 12232 ( Other Identifier: Company Internal )
• First Posted: July 3, 2009
• Last Update Posted: November 19, 2012
• Last Verified: November 2012

Keywords provided by Bayer:

Non-Interventional; Observational; NIS; Moxifloxacin; MXF; Avelox; AECB

Additional relevant MeSH terms:

Bronchitis; Bronchitis, Chronic; Bronchial Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female