Clinical Trial: AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis
Brief 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.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: Time until improvement of acute exacerbation [ Time Frame: End of study ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time until cure of acute exacerbation [ Time Frame: End of study ]
- Severity of AECB according to Antonisen criteria [ Time Frame: Baseline ]
- Impact of AECB on daily life activities [ Time Frame: Baseline ]
- Safety of Avelox under daily life treatment conditions [ Time Frame: Throughout treatment ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: February 18, 2009
Date Started: April 2008
Date Completion:
Last Updated: July 5, 2012
Last Verified: July 2012
