AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00846911
First received: February 18, 2009
Last updated: July 5, 2012
Last verified: July 2012
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Purpose
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.
Condition | Intervention |
---|---|
Bronchitis, Chronic |
Drug: Moxifloxacin (Avelox, BAY12-8039) |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Time until improvement of acute exacerbation [ Time Frame: End of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time until cure of acute exacerbation [ Time Frame: End of study ] [ Designated as safety issue: No ]
- Severity of AECB according to Antonisen criteria [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Impact of AECB on daily life activities [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Safety of Avelox under daily life treatment conditions [ Time Frame: Throughout treatment ] [ Designated as safety issue: Yes ]
Enrollment: | 2672 |
Study Start Date: | April 2008 |
Study Completion Date: | April 2010 |
Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Group 1 |
Drug: Moxifloxacin (Avelox, BAY12-8039)
Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin
|
Eligibility
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study Population
Primary care clinic
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846911
Locations
Albania | |
Many Locations, Albania | |
Bosnia and Herzegovina | |
Many Locations, Bosnia and Herzegovina | |
Kazakhstan | |
Many Locations, Kazakhstan | |
Macedonia, The Former Yugoslav Republic of | |
Many Locations, Macedonia, The Former Yugoslav Republic of | |
Moldova, Republic of | |
Many Locations, Moldova, Republic of | |
Russian Federation | |
Many Locations, Russian Federation | |
Slovakia | |
Many Locations, Slovakia | |
Ukraine | |
Many Locations, Ukraine |
Sponsors and Collaborators
Bayer
Investigators
Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
Keywords provided by Bayer:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2012
Additional Information:
No publications provided
Responsible Party: | Global Medical Affairs Head, Bayer HealthCare AG |
ClinicalTrials.gov Identifier: | NCT00846911 History of Changes |
Other Study ID Numbers: | 14689, AX0701, 13598, 13855, 13856, 13857, 14008, 14007, 14009 |
Study First Received: | February 18, 2009 |
Last Updated: | July 5, 2012 |
Health Authority: | Albania: Ministry of Health Department of Pharmacy Bosnia: Federal Ministry of Health Kazakhstan: Ethical Commission Moldavia: Ministry of Health Macedonia: Ministry of Health Russia: Ethics Committee Slovakia: State Institute for Drug Control Ukraine: Central Ethical Comission |
Keywords provided by Bayer:
Acute Exacerbation of Chronic Bronchitis (AECB) patients |
Additional relevant MeSH terms:
Bronchitis Acute Disease Bronchitis, Chronic Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Disease Attributes Pathologic Processes Pulmonary Disease, Chronic Obstructive |
Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2012