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OpenTrials
Completed

NCT Number: NCT00846911

AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs

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.

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Key information

Conditions

Bronchitis, Chronic Bronchial Diseases Bronchitis Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Albania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxifloxacin (Avelox, BAY12-8039)

Drug

Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin

Primary outcomes

  1. Time until improvement of acute exacerbation

    Time frame: End of study

Secondary outcomes

  1. Time until cure of acute exacerbation

    Time frame: End of study

  2. Severity of AECB according to Antonisen criteria

    Time frame: Baseline

  3. Impact of AECB on daily life activities

    Time frame: Baseline

  4. Safety of Avelox under daily life treatment conditions

    Time frame: Throughout treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 19, 2009
Registry last updated
Jul 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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