Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: RNS60
* Drug: Normal Saline
* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female non-smokers, aged between 18 and 65 years. Clinical diagnosis of mild to moderate asthma meeting NHLBI 2007 guidelines as outlined in Appendix A. Subjects who have a currently prescribed inhaled corticosteroid medication to treat asthma, alone or in combination with other medications, with usage of 1 month (≥ 95% compliance) or more on the inhaled corticosteroid treatment. Normal 12-lead ECG at Screening. Normal single view chest x-ray at Screening. Men and women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment (Day 57). Women of childbearing potential who have a negative pregnancy test (serum HCG) at the time of study entry, and again on Day 22. Subjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary, informed consent. Exclusion Criteria: Chronic or acute disease that might interfere with the evaluation of RNS60. Pregnancy, intent to become pregnant, or breastfeeding. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated). Positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody. Positive urine drug screen (UDS) for drugs of abuse including alcohol and cotinine at the time of study entry and again on Day 22. Infections that require intravenous antibiotic therapy. Significant organ dysfunction, including cardiac, renal, liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry. Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry. Treatment with any investigational drugs, therapies, or medical devices within 4 weeks prior to study entry. Any use of antidepressants or other psychiatric medicine within 4 weeks prior to study entry and/or during the study treatment period. Use of any over-the-counter asthma treatments, including Primatene Mist, during the 8-week active study period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RNS60-BD 0.25<br>RNS60 in combination with Budesonide 0.25mg/2ml concentration | Drug: RNS60<br>* RNS60, 2ml, nebulized twice daily.<br>Drug: Budesonide<br>* 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.<br>|
| Experimental: RNS60-BD 0.5<br>RNS60 in combination with Budesonide 0.5mg/2ml concentration | Drug: RNS60<br>* RNS60, 2ml, nebulized twice daily.<br>Drug: Budesonide<br>* 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.<br>|
| Placebo Comparator: NS-BD 0.5<br>Normal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration | Drug: Normal Saline<br>* Normal Saline placebo, 2 ml, nebulized twice daily.<br>Drug: Budesonide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |