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

Sponsor

Revalesio Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01511302

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

16.3

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: RNS60 Drug: Normal Saline Drug: Budesonide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in peak expiratory flow [Baseline to 56 days]
Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by daily peak expiratory flow values.
Change in quality of life [56 days]
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 [56 days]
Evidence that RNS60 in combination with budesonide does not increase rescue inhaler usage, as measured by patient diary.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Clinical Trials	Costa Mesa	California	United States	92626
2	California Allergy and Asthma	Los Angeles	California	United States	90025
3	Axis Clinical Trials	Los Angeles	California	United States	90036
4	Integrated Research Group	Riverside	California	United States	92506

Sponsors and Collaborators

Revalesio Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Revalesio Corporation

ClinicalTrials.gov Identifier:

NCT01511302

Other Study ID Numbers:

01.1.1.H2

First Posted:

Jan 18, 2012

Last Update Posted:

Jul 28, 2014

Last Verified:

Jul 1, 2014

Additional relevant MeSH terms:

Asthma

Budesonide

RNS60

Study Results

No Results Posted as of Jul 28, 2014