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

NCT ID: NCT01511302

Last Updated: 2014-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-05-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RNS60-BD 0.25

RNS60 in combination with Budesonide 0.25mg/2ml concentration

Group Type: EXPERIMENTAL

RNS60

Intervention Type: DRUG

RNS60, 2ml, nebulized twice daily.

Budesonide

Intervention Type: DRUG

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.

RNS60-BD 0.5

RNS60 in combination with Budesonide 0.5mg/2ml concentration

Group Type: EXPERIMENTAL

RNS60

Intervention Type: DRUG

RNS60, 2ml, nebulized twice daily.

Budesonide

Intervention Type: DRUG

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.

NS-BD 0.5

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

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Normal Saline placebo, 2 ml, nebulized twice daily.

Budesonide

Intervention Type: DRUG

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.

Interventions

RNS60

RNS60, 2ml, nebulized twice daily.

Intervention Type: DRUG

Normal Saline

Normal Saline placebo, 2 ml, nebulized twice daily.

Intervention Type: DRUG

Budesonide

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Revalesio Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

01.1.1.H2

Identifier Type: -

Identifier Source: org_study_id