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

Revalesio

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: RNS60; Drug: Budesonide; Drug: Normal Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511302

01.1.1.H2

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

65 participants in 3 patient groups, including a placebo group

RNS60-BD 0.25

Experimental group

Description:

RNS60 in combination with Budesonide 0.25mg/2ml concentration

Treatment:

Drug: Budesonide

Drug: RNS60

RNS60-BD 0.5

Experimental group

Description:

RNS60 in combination with Budesonide 0.5mg/2ml concentration

Treatment:

Drug: Budesonide

Drug: RNS60

NS-BD 0.5

Placebo Comparator group

Description:

Normal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration

Treatment:

Drug: Budesonide

Drug: Normal Saline