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| ID | Type | Description | Link |
|---|---|---|---|
| C4681001 | Other Identifier | Alias Study Number |
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This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the US will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-502 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-502, CRTh2 antagonist; oral | Drug | multiple dose, single schedule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. | 6 weeks | |
| Measure the exposure of study drug in terms of plasma concentrations. | 6 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy & Asthma Specialists Medical Group | Huntington Beach | California | 92647 | United States | ||
| Allergy Medical Clinic - Research Division |
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Placebo; oral |
| Drug |
matching placebo |
|
| Assess the effect of study drug on asthma control in terms of Asthma Control Questionnaire (ACQ) score, the number of symptom-free days and the number of weekly short-acting beta (ß) 2 agonist (SABA) metered dose inhaler (MDI) actuations. | 6 weeks |
| Assess the effect of study drug on respiratory function in terms of FEV1, forced vital capacity (FVC), forced expiratory flow (FEF) and peak expiratory flow (PEF). | 6 weeks |
| Los Angeles |
| California |
| 90025 |
| United States |
| California Allergy & Asthma Med. Group | Los Angeles | California | 90025 | United States |
| Southern California Institute for Respiratory Diseases Inc | Los Angeles | California | 90048 | United States |
| Southern California Research | Mission Viejo | California | 92691 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| Allergy Associates Medical Group | San Diego | California | 92120 | United States |
| Colorado Allergy and Asthma Center | Centennial | Colorado | 80112 | United States |
| IMMUNOe International Research Centers | Centennial | Colorado | 80112 | United States |
| Asthma & Allergy Associates PC | Colorado Springs | Colorado | 80909 | United States |
| Rocky Mountain Center for Clinical Research | Wheat Ridge | Colorado | 80033 | United States |
| Clinical Neuroscience Solutions | Jacksonville | Florida | 32256 | United States |
| Pulmonary Disease Specialists | Kissimmee | Florida | 34741 | United States |
| South Florida Research Trials | Miami | Florida | 33186 | United States |
| Allergy & Asthma Diagnostic Treatment Center | Tallahassee | Florida | 32308 | United States |
| Florida Pulmonary Research Institute | Winter Park | Florida | 32789 | United States |
| Idaho Research | Eagle | Idaho | 83616 | United States |
| Sneeze, Wheeze & Itch | Normal | Illinois | 61761 | United States |
| Chesapeake Clinical Research Inc | Baltimore | Maryland | 21236 | United States |
| Northeast Medical Research Associates | North Dartmouth | Massachusetts | 02747 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| Clinical Research Institute | Plymouth | Minnesota | 55441 | United States |
| Clinical Research Group of Montana | Bozeman | Montana | 59718 | United States |
| The Asthma & Allergy Center | Bellevue | Nebraska | 68123 | United States |
| Princeton Center for Clinical Research | Skillman | New Jersey | 08558 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Allergy, Respiratory & Sleep Center | Canton | Ohio | 44718 | United States |
| Bernstein Clinical Research | Cincinnati | Ohio | 45231 | United States |
| Toledo Center for Clinical Research | Sylvania | Ohio | 43560 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Allergy Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | 74136 | United States |
| Baker Allergy, Asthma & Dermatology Research Center | Lake Oswego | Oregon | 97035 | United States |
| Clinical Research Institute of Southern Oregon | Medford | Oregon | 97504 | United States |
| University of Pittsburgh Asthma Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| Pharmaceutical Research & Consulting Inc. | Dallas | Texas | 75231 | United States |
| Western Sky Medical Research Inc | El Paso | Texas | 79903 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Asthma Inc. | Seattle | Washington | 98105 | United States |
| Allergy Asthma & Sinus Center, S.C. | Greenfield | Wisconsin | 53228 | United States |
| Asthma Allergy & Pulmonary Research | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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