Treatment of Patients With Acute Sinusitis

This study has been completed.
Information provided by:
Bayer Identifier:
First received: June 29, 2009
Last updated: November 19, 2012
Last verified: November 2012

For each patient, an initial visit and at least one follow-up visit at the end of treatment should be documented by the treating physician in the case report form.

Condition Intervention
Acute Bacterial Sinusitis
Drug: Avelox (Moxifloxacin, BAY12-8039)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Patients With Acute Sinusitis in Daily Practice

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Evaluation of potential benefits of an antibacterial therapy with Avelox® (moxifloxacin) in patients with acute bacterial sinusitis to whom this treatment was prescribed. Especially the time to improvement and resolution of clinical signs and symptoms of [ Time Frame: Documentation at baseline and at at least one follow-up visit. Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of tolerability and safety of Avalox® in daily practice were investigated. [ Time Frame: Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days). ] [ Designated as safety issue: Yes ]
  • Patient characteristics in acute bacterial sinusitis [ Time Frame: Documentation at baseline visit. ] [ Designated as safety issue: No ]
  • History and frequency of sinusitis episodes [ Time Frame: Documentation at baseline visit. ] [ Designated as safety issue: No ]
  • Diagnostic procedures and therapeutic options chosen by physicians in daily practice [ Time Frame: Documentation at baseline visit. ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained


Enrollment: 6777
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin


Inclusion Criteria:

  • Any patient with a diagnosis of acute bacterial sinusitis treated with Avelox® - in accordance with the local production information.

Exclusion Criteria:

  • Those specified in the local product information - contraindications and precautions must be considered.
  Contacts and Locations
Please refer to this study by its identifier: NCT00930488

  Show 19 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00930488     History of Changes
Other Study ID Numbers: 12803, TOPAS, AX 0601, 12867 - AX0601AT, 12868 - AX0601PK, 12869 - AX0601EG, 12870 - AX0601NL, 12973 - AX0601SK, 12974 - AX0601SG, 13026 - AX0601ID, 13046 - AX0601PH, 13111 - AX0601RO, 13065 - AX0601CN, 13207 - AX0601FR, 13166 - AX0601MY
Study First Received: June 29, 2009
Last Updated: November 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Ministry of Health
Pakistan: Ministry of Health
Pakistan: Research Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Indonesia: National Agency of Drug and Food Control
Philippines: Department of Health
China: Ethics Committee
China: Ministry of Health
China: National Natural Science Foundation
China: Food and Drug Administration
Romania: Ethics Committee
Malaysia: Ministry of Health
France: French Data Protection Authority
Jordan: Ethical Committee
Lebanon: Institutional Review Board
Lebanon: Ministry of Public Health
Saudi Arabia: Ministry of Health
Saudi Arabia: Research Advisory Council

Keywords provided by Bayer:
Acute bacterial sinusitis, ABS

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
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 processed this record on April 15, 2014