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

Completed · Phase 1 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01511302

Run by

Revalesio Corporation

People needed

65

Starts

2012-06-01

Expected to finish

2013-05-01

Last updated by the study team

2014-07-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• West Coast Clinical Trials — Costa Mesa, California, United States
• California Allergy and Asthma — Los Angeles, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Integrated Research Group — Riverside, California, United States

Full record on ClinicalTrials.gov

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