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Study terminated due to lack of care guidelines in the protocol.
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This study is designed to show that pharmacotherapy guided by eNO and clinical standard of care produces a superior outcome to trial-based therapy guided by clinical standard of care alone.
Patients with persistent, moderate to severe asthma will be randomized to receive therapy guided by either eNO and clinical standard of care (eNO group) or clinical standard of care (control group). An eNO treatment algorithm will be established for each patient in the eNO group at Baseline (Visit 1). Enrollment is estimated to be six months with a follow up period of twelve months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eNO group | Active Comparator | eNO measurement is used to inform asthma management decisions |
|
| control group | No Intervention | Asthma is managed according to existing standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apieron Insight eNO monitor | Device | The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control days | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William E Berger, MD, MBA | Southern California Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Research | Mission Viejo | California | 92691 | United States | ||
| Allergy & Asthma Associates of Santa Clara Valley Research Center |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| San Jose |
| California |
| 95117 |
| United States |
| Allergy Associates of Hartford | Glastonbury | Connecticut | 06033 | United States |
| Asthma and Allergy Center of Chicago, S.C. | River Forest | Illinois | 60305 | United States |
| The Asthma- Allergy Clinic& Research Center | Shreveport | Louisiana | 71105 | United States |
| Chesapeake Clinical Research | Baltimore | Maryland | 21236 | United States |
| The Clinical Research Center, LLC | St Louis | Missouri | 63141 | United States |
| Center for Allergy and Asthma | Highland Park | New Jersey | 08904 | United States |
| Pulmonary & Allergy Associates P.A. | Summit | New Jersey | 07901 | United States |
| Allergy, Asthma & Dermatology Research Center, LLC | Lake Oswego | Oregon | 97035 | United States |
| Asthma & Allergy Research Associates | Upland | Pennsylvania | 19013 | United States |
| Pharmaceutical Research & Consulting, Inc. | Dallas | Texas | 75231 | United States |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |