Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT01511302
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01511302
Study Brief:
Protocol Section:
NCT01511302