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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511302
• Other study ID #: 01.1.1.H2
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2012
• Last updated: July 24, 2014
• Start date: June 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: Revalesio Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• RNS60
RNS60, 2ml, nebulized twice daily.
• Normal Saline
Normal Saline placebo, 2 ml, nebulized twice daily.
• 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.

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Costa Mesa	California
United States	Axis Clinical Trials	Los Angeles	California
United States	California Allergy and Asthma	Los Angeles	California
United States	Integrated Research Group	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
Revalesio Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change in peak expiratory flow	Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by daily peak expiratory flow values.	Baseline to 56 days	Yes
Secondary	Change in quality of life	Evidence that RNS60 in combination with budesonide does not reduce patient's quality of life, as measured by weekly QOL questionnaire over 28 days.	56 days	No
Secondary	Change in rescue inhaler usage	Evidence that RNS60 in combination with budesonide does not increase rescue inhaler usage, as measured by patient diary.	56 days	Yes