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Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma

NCT01511302•Revalesio Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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.
+1 more criteria

Locations (4)

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

Key Dates

Start Date

June 1, 2012

Primary Completion Date

April 1, 2013

Completion Date

May 1, 2013

Last Updated

July 28, 2014

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

RNS60

DRUG

Normal Saline

DRUG

Budesonide

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

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RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma