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AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchitis, Chronic

Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

The objective of this global non-interventional study is to evaluate the impact of Acute Exacerbation of Chronic Bronchitis(AECB) on the patient and the community as well as the safety and effect of a treatment with Moxifloxacin tablets in daily life clinical practice. This includes data on the course of symptom relief, speed of return to normal daily life activities as well as records on adverse events. This study will be performed in accordance with international guidelines like EMEA (EMEA, EUDRALEX Volume 9A, Pharmacovigilance for Medicinal Products for Human Use) as well as local laws.

Clinical Details

Official title: AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Time until improvement of acute exacerbation

Secondary outcome:

Time until cure of acute exacerbation

Severity of AECB according to Antonisen criteria

Impact of AECB on daily life activities

Safety of Avelox under daily life treatment conditions

Eligibility

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients at least 35 years of age with a diagnosis of Acute Exacerbation of Chronic

Bronchitis (AECB) and decision taken by the investigator to treat with Avelox. Exclusion Criteria:

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

Locations and Contacts

Many Locations, Albania

Many Locations, Bosnia and Herzegovina

Many Locations, Kazakhstan

Many Locations, Macedonia, The Former Yugoslav Republic of

Many Locations, Moldova, Republic of

Many Locations, Russian Federation

Many Locations, Slovakia

Many Locations, Ukraine

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: April 2008
Last updated: July 5, 2012

Page last updated: August 23, 2015

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