Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: RNS60 Drug: Normal Saline Drug: Budesonide	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Revalesio Corporation:

Primary Outcome Measures:

Change in Forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to 56 days ] [ Designated as safety issue: Yes ]
Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores.

Secondary Outcome Measures:

Change in peak expiratory flow [ Time Frame: Baseline to 56 days ] [ Designated as safety issue: Yes ]
Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by daily peak expiratory flow values.
Change in quality of life [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Evidence that RNS60 in combination with budesonide does not reduce patient's quality of life, as measured by weekly QOL questionnaire over 28 days.
Change in rescue inhaler usage [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
Evidence that RNS60 in combination with budesonide does not increase rescue inhaler usage, as measured by patient diary.

Enrollment:	65
Study Start Date:	June 2012
Study Completion Date:	May 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RNS60-BD 0.25 RNS60 in combination with Budesonide 0.25mg/2ml concentration	Drug: RNS60 RNS60, 2ml, nebulized twice daily. 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.
Experimental: RNS60-BD 0.5 RNS60 in combination with Budesonide 0.5mg/2ml concentration	Drug: RNS60 RNS60, 2ml, nebulized twice daily. 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.
Placebo Comparator: NS-BD 0.5 Normal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration	Drug: Normal Saline Normal Saline placebo, 2 ml, nebulized twice daily. 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511302

Locations

United States, California
West Coast Clinical Trials
Costa Mesa, California, United States, 92626
Axis Clinical Trials
Los Angeles, California, United States, 90036
California Allergy and Asthma
Los Angeles, California, United States, 90025
Integrated Research Group
Riverside, California, United States, 92506

Sponsors and Collaborators

Revalesio Corporation

More Information

No publications provided

Responsible Party:	Revalesio Corporation
ClinicalTrials.gov Identifier:	NCT01511302 History of Changes
Other Study ID Numbers:	01.1.1.H2
Study First Received:	January 12, 2012
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 13, 2013