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

NCT01511302 | Completed Phase 1

• 1 other identifier: 01.1.1.H2
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Change in Forced expiratory volume in 1 second (FEV1)

  Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores.

  Baseline to 56 days

Secondary Outcomes (3)

• Change in peak expiratory flow

  Baseline to 56 days

• Change in quality of life

  56 days

• Change in rescue inhaler usage

  56 days

Study Arms (3)

RNS60-BD 0.25

EXPERIMENTAL

RNS60 in combination with Budesonide 0.25mg/2ml concentration

Drug: RNS60; Drug: Budesonide

RNS60-BD 0.5

EXPERIMENTAL

RNS60 in combination with Budesonide 0.5mg/2ml concentration

Drug: RNS60; Drug: Budesonide

NS-BD 0.5

PLACEBO COMPARATOR

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

Drug: Normal Saline; Drug: Budesonide

Interventions

RNS60 DRUG

RNS60, 2ml, nebulized twice daily.

RNS60-BD 0.25; RNS60-BD 0.5

Normal Saline DRUG

Normal Saline placebo, 2 ml, nebulized twice daily.

NS-BD 0.5

Budesonide 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; RNS60-BD 0.25; RNS60-BD 0.5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revalesio Corporation: lead

Study Sites (4)

West Coast Clinical Trials

Costa Mesa, California, 92626, United States

Location

California Allergy and Asthma

Los Angeles, California, 90025, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Integrated Research Group

Riverside, California, 92506, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

RNS60; Saline Solution; Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 18, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

US (4)