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