Asthma
Conditions
Brief 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.
Interventions
DRUGRNS60
RNS60, 2ml, nebulized twice daily.
DRUGNormal Saline
Normal Saline placebo, 2 ml, nebulized twice daily.
DRUGBudesonide
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.
Sponsors
Revalesio Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced expiratory volume in 1 second (FEV1) | Baseline to 56 days | Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in peak expiratory flow | Baseline to 56 days | Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by daily peak expiratory flow values. |
| Change in quality of life | 56 days | Evidence that RNS60 in combination with budesonide does not reduce patient's quality of life, as measured by weekly QOL questionnaire over 28 days. |
| Change in rescue inhaler usage | 56 days | Evidence that RNS60 in combination with budesonide does not increase rescue inhaler usage, as measured by patient diary. |
Countries
United States
Outcome results
None listed