Status:
COMPLETED
Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma
Lead Sponsor:
Revalesio Corporation
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01511302
Start Date
June 1 2012
End Date
May 1 2013
Last Update
July 28 2014
Active Locations (4)
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1
West Coast Clinical Trials
Costa Mesa, California, United States, 92626
2
California Allergy and Asthma
Los Angeles, California, United States, 90025
3
Axis Clinical Trials
Los Angeles, California, United States, 90036
4
Integrated Research Group
Riverside, California, United States, 92506