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The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.
The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either R343 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R940343 2mg, 2 puffs bid | Active Comparator | R343 2mg, 2 puffs bid |
|
| Placebo | Placebo Comparator |
| |
| R940343 1mg, 1 puff bid | Active Comparator | R343 1mg, 1 puff bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 1 puff bid or 2 puffs bid |
| |
| R940343 1mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 | Change from baseline in pre-BD FEV1 (% predicted) at Week 8. | Baseline and Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliott Grossbard, MD | Rigel Pharmaceuticals,Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Research Medical Group, Inc | Fullerton | California | 92835 | United States | ||
| Allergy Medical Clinic Research Division |
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| ID | Title | Description |
|---|---|---|
| FG000 | R940343 2mg, 2 Puffs Bid | R343 2mg, 2 puffs bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid |
| FG001 | Placebo | Placebo: 1 puff bid or 2 puffs bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
R343 1mg, 1 puff bid |
|
|
| R940343 2mg | Drug | R343 2mg, 2 puffs bid |
|
|
| Los Angeles |
| California |
| 90025 |
| United States |
| California Allergy & Asthma Medical Group, INC | Los Angeles | California | 90025 | United States |
| Southern California Institute for Respiratory Diseases, Inc. | Los Angeles | California | 90048 | United States |
| Allergy & Asthma Associates of Southern California | Mission Viejo | California | 92691 | United States |
| CHOC PSF, AMC, Division of Allergy, Asthma & Immunology | Orange | California | 92868 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| Allergy Associates Medical Group. Inc. | San Diego | California | 92120 | United States |
| Allergy & Asthma Med Group/Research Center | San Diego | California | 92123 | United States |
| Allergy & Asthma Associates of Santa Clara Valley | San Jose | California | 95117 | United States |
| Bensch Research Associates | Stockton | California | 95207 | United States |
| Colorado Allergy and Asthma Clinic, PC | Centennial | Colorado | 80112 | United States |
| Asthma & Allergy Associates, PC | Colorado Springs | Colorado | 80907 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Colorado Allergy & Asthma Centers, PC | Denver | Colorado | 80230 | United States |
| Florida Center for Allergy & Asthma Research | Aventura | Florida | 33180 | United States |
| Accelovance | Melbourne | Florida | 32935 | United States |
| Sarasota Clinical Research | Sarasota | Florida | 34233 | United States |
| Georgia Pollens Clinical Research Centers, Inc. | Albany | Georgia | 31707 | United States |
| Idaho Allergy DBA Idaho Research | Eagle | Idaho | 83616 | United States |
| Sneeze, Wheeze & Itch Associates | Normal | Illinois | 61761 | United States |
| Chesapeake Clinical Research, Inc. | Baltimore | Maryland | 21236 | United States |
| Northeast Medical Research Associates, Inc. | North Dartmouth | Massachusetts | 02747 | United States |
| Respiratory Medicine Researh Institute of Michigan | Ypsilanti | Michigan | 48197 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| Clinical Research Institute, Inc. | Plymouth | Minnesota | 55441 | United States |
| Clinical Research of The Ozarks, Inc. | Columbia | Missouri | 65203 | United States |
| The Clinical Research Center, LLC | St Louis | Missouri | 63141 | United States |
| Clinical Research Group of Montana PLLC | Bozeman | Montana | 59718 | United States |
| The Asthma & Allergy Center | Bellevue | Nebraska | 68123 | United States |
| Atlantic Research Center, LLC | Ocean City | New Jersey | 07712 | United States |
| Princeton Center for Clinical Research | Skillman | New Jersey | 08558 | United States |
| Allergy Consultants, PA | Verona | New Jersey | 07044 | United States |
| New York Pulmonary Associates, P.C. | New York | New York | 10016 | United States |
| Allergy Asthma Immunology of Rochester (AAIR) | Rochester | New York | 14618 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Allergy & Asthma Research Group | Eugene | Oregon | 97401-7721 | United States |
| Clinical Research Inst. of Southern Oregon, PC | Medford | Oregon | 97504 | United States |
| Allergy Associates Research Center | Portland | Oregon | 97202 | United States |
| Allergy & Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | United States |
| National Allergy, Asthma and Uticaria Center of Charleston | Charleston | South Carolina | 29406 | United States |
| Pharmaceutical Research & Consulting, Inc. | Dallas | Texas | 75231 | United States |
| Western Sky Medical Research, Inc. | El Paso | Texas | 79903 | United States |
| Live Oak Allergy & Asthma Clinic | Live Oak | Texas | 78233 | United States |
| Allergy & Asthma Care of Waco, PA | Waco | Texas | 76712 | United States |
| Allergy Asthma Research Institute | Waco | Texas | 76712 | United States |
| ASTHMA, Inc. | Seattle | Washington | 98115 | United States |
| MultiCare Pulmonary Specialists | Tacoma | Washington | 98405 | United States |
| Joseph Greenbaum, MD | Hamilton | Ontario | L8N 1Y2 | Canada |
| Cheema Research, Inc. | Missassauga | Ontario | L5A 3V4 | Canada |
| Niagara Clinical Research | Niagara Falls | Ontario | L2G 1J4 | Canada |
| Ottawa Allergy Research Corp | Ottawa | Ontario | K1Y 4G2 | Canada |
| Pulmonary Care Clinic | Toronto | Ontario | M5G 1N8 | Canada |
| Primary Care Lung Clinic | Toronto | Ontario | M6H 3M2 | Canada |
| Dynamik Research, Inc. | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Centre De recherche Appliquee en Allergie DeQuebec | Québec | Quebec | G1V 4M6 | Canada |
| FG002 | R940343 1mg, 1 Puff Bid | R343 1mg, 1 puff bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid |
| COMPLETED |
|
| NOT COMPLETED |
|
For the purpose of analysis, participants randomized to the two different dosage levels of the placebo were considered a single Arm/Group.
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| ID | Title | Description |
|---|---|---|
| BG000 | R940343 2mg, 2 Puffs Bid | R343 2mg, 2 puffs bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid |
| BG001 | Placebo | Placebo: 1, 1 puff bid or 2, 2 puffs bid |
| BG002 | R940343 1mg, 1 Puff Bid | R343 1mg, 1 puff bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in FEV1 | Change from baseline in pre-BD FEV1 (% predicted) at Week 8. | All efficacy endpoints were analyzed based on the intent to treat population consisting of all randomized patients. | Posted | Mean | Standard Deviation | percentage of change | Baseline and Week 8 |
|
|
|
The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R940343 2mg, 2 Puffs Bid | R343 2mg, 2 puffs bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid | 0 | 101 | 36 | 101 | ||
| EG001 | Placebo | Placebo: 1, 1 puff bid or 2, 2 puffs bid | 0 | 100 | 48 | 100 | ||
| EG002 | R940343 1mg, 1 Puff Bid | R343 1mg, 1 puff bid R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid | 0 | 100 | 26 | 100 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Disorders | Eye disorders | Non-systematic Assessment |
| ||
| BLOOD AND LYMPHATIC SYSTEM DISORDERS | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Cardiac Disorders | Cardiac disorders | Non-systematic Assessment |
| ||
| Ear and Labyrinth Disorders | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Gastrointestinal Disorders | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| General Disorders and Administration Site Conditions | General disorders | Non-systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Non-systematic Assessment |
| ||
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Investigations | Investigations | Non-systematic Assessment |
| ||
| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| NERVOUS SYSTEM DISORDERS | Nervous system disorders | Non-systematic Assessment |
| ||
| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
| ||
| Renal and urinary disorders | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Reproductive system and breast disorders | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne-Marie Duliege, MD | Rigel | 650-624-1100 | clinicaltrials@rigel.com |
| 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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| Male |
|