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The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amphotericin B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SinuNase | Drug | Lavage |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS. | Four months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angelos M Stergiou, MD | Accentia Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | United States | ||
| Alabama ENT Associates |
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| Birmingham |
| Alabama |
| 35244 |
| United States |
| Clinical Research Advantage | Gilbert | Arizona | 85234 | United States |
| NEA Clinic | Jonesboro | Arkansas | 72401 | United States |
| Kern Allergy Medical Clinic | Bakersfield | California | 93301 | United States |
| SARC Research Center | Fresno | California | 93720 | United States |
| California Allergy & Asthma Medical Group, Inc. | Los Angeles | California | 90025 | United States |
| CHOC PSF, AMC, Division of Allergy, Asthma & Immunology | Orange | California | 92868 | United States |
| Integrated Research Group Inc. | Riverside | California | 92506 | United States |
| Allergy Medical Group of the North Area | Roseville | California | 95678 | United States |
| Sacramento ENT | Sacramento | California | 95816 | United States |
| Allergy & Asthma Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Pravin K. Muniyappa, MD, Inc. | West Hills | California | 91307 | United States |
| First Allergy & Clinical Research Center | Centennial | Colorado | 80112 | United States |
| Colorado Otolaryngology Associates, PC | Colorado Springs | Colorado | 80909 | United States |
| Connecticut Sinus Center | Bridgeport | Connecticut | 06606 | United States |
| Bay Front Medical Center | St. Petersburg | Florida | 33701 | United States |
| Allergy Center at Brookstone | Columbus | Georgia | 31904 | United States |
| Allergy & Asthma Care Center | Gainesville | Georgia | 30501 | United States |
| Northeast Georgia Research Center | Gainesville | Georgia | 30501 | United States |
| Northwest ENT Associates | Marietta | Georgia | 30060 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Chest Medicine Consultants | Chicago | Illinois | 60657 | United States |
| Asthma And Allergy Center Of Chicago | River Forest | Illinois | 60305 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| Kansas City Allergy & Asthma | Overland Park | Kansas | 66210 | United States |
| Commonwealth ENT, Head and Neck Center | Louisville | Kentucky | 40207 | United States |
| Paul A. Shapero, MD | Bangor | Maine | 04401 | United States |
| Institute of Allergy & Asthma | Wheaton | Maryland | 20902 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Grand Traverse Allergy | Traverse City | Michigan | 49684 | United States |
| Clinical Research Institute | Plymouth | Minnesota | 55441 | United States |
| Jefferson City Medical Group | Jefferson City | Missouri | 65109 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| Midwest Clinical Research, LLC | St Louis | Missouri | 63141 | United States |
| Allergy & Asthma Consultants of Montana | Bozeman | Montana | 59718 | United States |
| Central Jersey Health Care | Elizabeth | New Jersey | 07202 | United States |
| David Sherris, M.D. | Buffalo | New York | 14216 | United States |
| Health Sciences Research Center | Ithaca | New York | 14850 | United States |
| Wellington Tichenor, MD | New York | New York | 10021 | United States |
| DiGiovanna Family Care Center | North Massapequa | New York | 11758 | United States |
| AAIR Research Center | Rochester | New York | 14618 | United States |
| Center for Allergy & Asthma of Bronx & Westchester | The Bronx | New York | 10465 | United States |
| Allergy Partners of Western North Carolina | Asheville | North Carolina | 28801 | United States |
| Charlotte Eye, Ear, Nose & Throat Associates, P.A. | Charlotte | North Carolina | 28210 | United States |
| Dr. Ann Bogard Private Practice | Winston-Salem | North Carolina | 27103-4146 | United States |
| Odyssey Research | Bismarck | North Dakota | 58501 | United States |
| Center for Specialty Care | Fargo | North Dakota | 58104 | United States |
| Hightop Medical Research Center | Cincinnati | Ohio | 45224 | United States |
| Optimed Research | Columbus | Ohio | 43235 | United States |
| Toledo Center for Clinical Research | Sylvania | Ohio | 43560 | United States |
| COR Clinical Research | Oklahoma City | Oklahoma | 73103 | United States |
| Allergy and Asthma Research of NJ, Inc. | Philadelphia | Pennsylvania | 19115 | United States |
| ADAC Research | Greenville | South Carolina | 29607 | United States |
| Sterling ENT / Carolina Research | Orangeburg | South Carolina | 29118-4900 | United States |
| The Asthma Institute, PLLC | Chattanooga | Tennessee | 37421 | United States |
| Jackson Clinic | Jackson | Tennessee | 38301 | United States |
| Vanderbilt University ASAP Research | Nashville | Tennessee | 37203-1424 | United States |
| Texas Medical and Surgical Associates | Dallas | Texas | 75231 | United States |
| University Of North Texas Health Science Center | Fort Worth | Texas | 76107-2699 | United States |
| Allergy & Asthma Associates | Houston | Texas | 77054 | United States |
| San Antonio Ear, Nose & Throat Research | San Antonio | Texas | 78229 | United States |
| Live Oak Allergy & Asthma Clinic | San Antonio | Texas | 78233 | United States |
| King's Daughters Clinic | Temple | Texas | 76502 | United States |
| Virginia Adult & Pediatric Allergy & Asthma, P.C. | Richmond | Virginia | 23229 | United States |
| Liberty Research Center | Tacoma | Washington | 98405 | United States |
| Monroe Medical Foundation | Monroe | Wisconsin | 53566 | United States |