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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Revalesio Corporation
• Treatments: Budesonide; RNS60

Criteria

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.