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The purpose of this study is to determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RNS60-BD 0.25 | Experimental | RNS60 in combination with Budesonide 0.25mg/2ml concentration |
|
| RNS60-BD 0.5 | Experimental | RNS60 in combination with Budesonide 0.5mg/2ml concentration |
|
| NS-BD 0.5 | Placebo Comparator | Normal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNS60 | Drug | RNS60, 2ml, nebulized twice daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced expiratory volume in 1 second (FEV1) | Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores. | Baseline to 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak expiratory flow | Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by daily peak expiratory flow values. | Baseline to 56 days |
| Change in quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Costa Mesa | California | 92626 | United States | ||
| California Allergy and Asthma |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000627108 | RNS60 |
| D000077330 | Saline Solution |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline |
| Drug |
Normal Saline placebo, 2 ml, nebulized twice daily. |
|
| Budesonide | Drug | Budesonide, in either 0.25 mg or 0.5 mg per 2 ml concentration in liquid suspension, nebulized once per day in combination with RNS60 or NS. |
|
Evidence that RNS60 in combination with budesonide does not reduce patient's quality of life, as measured by weekly QOL questionnaire over 28 days.
| 56 days |
| Change in rescue inhaler usage | Evidence that RNS60 in combination with budesonide does not increase rescue inhaler usage, as measured by patient diary. | 56 days |
| Los Angeles |
| California |
| 90025 |
| United States |
| Axis Clinical Trials | Los Angeles | California | 90036 | United States |
| Integrated Research Group | Riverside | California | 92506 | United States |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011282 |
| Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |