Center for Drug Evaluation and Research




October 29, 2003


Holiday Inn, The Ballrooms, Two Montgomery Village Avenue, Gaithersburg, MD


Topic:  Clinical trial design in Acute Bacterial Sinusitis (ABS)




8:30 a.m.          Call to Order                                                                 James E. Leggett, Jr., M.D.

                                                                                                            Chair, AIDAC

                        Introduction of Committee


                        Conflict of Interest Statement                                         Tara P. Turner, Pharm. D.

                                                                                                            Executive Secretary, AIDAC


8:40 a.m.          General Overview: Antimicrobial                                 Renata Albrecht, M.D.

                        Development for ABS,                                                 Director

                        Regulatory History                                                      Division of Special Pathogen

and Immunologic Drug Products, FDA


9:00 a.m.          Acute Bacterial Sinusitis: Overview                              Jack M. Gwaltney, Jr., M.D.

                                                                                                            Professor Emeritus, Division Head

Division of Epidemiology and Virology

University of Virginia



9:40 a.m.          Description of Sinus Puncture                                      Thomas A. Sydnor, Jr., M.D.


                                                                                                            Virginia Medical Studies (Retired)




10:00 a.m.         Statistical Considerations in Clinical Trial                   Thomas R. Fleming, Ph.D.

Design in ABS                                                              Professor and Chair

Department of Biostatistics

University of Washington


10:30 a.m.         Break



10:45 a.m.         Clinical Evaluation of ABS:                                         Carl Kraus, M.D.

                        Diagnostic Considerations                                           Medical Officer

                                                                                                            Division of Special Pathogen and

                                                                                                            Immunologic Drug Products, FDA








11:15 a.m.         Lesson Learned from Clinical Trial                             Janice Pohlman, M.D.

                        Design in Past Approvals                                             Medical Officer

                                                                                                            Division of Anti-Infective Drug Products



11:45 a.m.         Clinical Trial Design in ABS:                                       John H. Powers, M.D.

                        Considerations for Future Guidance                            Lead Medical Officer for

                                                                                                            Antimicrobial Drug Development

                                                                                                            Office of Drug Evaluation IV, FDA


12:15 p.m         Lunch


1:15 p.m.          Open Public Hearing


1:45 p.m.          Charge to Committee                                                     Edward Cox, M.D., M.P.H.

                                                                                                            Deputy Director

                                                                                                            Office of Drug Evaluation IV, FDA


1:50 p.m.          Committee Discussion


4:30 p.m.          Adjourn








  1. How does one ensure that patients in clinical trials of acute bacterial sinusitis have bacterial disease?  Please discuss the methods of obtaining microbiologic data including sinus punctures and nasal endoscopy.


  1. Please discuss the issues of trial design in the study of acute bacterial sinusitis.  Please include in your discussion:
    1. the strengths and limitations of placebo-controlled trials and non-inferiority trials. Please discuss how one determines a non-inferiority margin in non-inferiority trials for this indication.
    2. the strengths and limitations of comparative microbiologic data.


3.      Please discuss the issues of measuring outcomes in patients in trials of acute bacterial sinusitis.  Please include in your discussion measuring time-to-resolution of symptoms as an endpoint compared to fixed endpoints.