Safety Study of Nebulized RNS60 to Treat Asthma.

Asthma Clinical Trial

Official title:

A Phase I Study of Nebulized RNS60 in Adult Healthy Subjects and Patients With Mild to Moderate Asthma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057498
• Other study ID #: 01.1.1.H1
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2010
• Last updated: January 11, 2012
• Start date: May 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2012
• 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 two-fold. First, to determine whether nebulized RNS60 is safe in healthy human subjects and in subjects with mild asthma, in a single-dose administration. Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate asthma over a 4-week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

For single-dose safety (Groups 1a and 1b):

1. Male or female, aged 18 to 65 years.

2.1. For healthy subjects; clinically considered "healthy" and no diagnosis of asthma.

2.2. For subjects with mild asthma, clinical diagnosis of mild chronic asthma as determined by National Heart, Lung, and Blood Institute's (NHLBI) 2007 guidelines, and who are not regularly using a chronic asthma medication (< 3 doses/week).

3. Subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent.

4. Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry.

For multi-dose safety study (Group 2e):

1. Male or female, aged 18 to 65 years.

2. Patients with clinical diagnosis of mild to moderate asthma, as determined by NHLBI 2007 guidelines, who are not already using a chronic asthma medication.

3. Historical documentation of asthma in the patient's medical record.

4. Men and women of reproductive potential who document use of adequate contraception during the study and for 1 month following the last day of treatment (Day 28).

5. Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry.

6. 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 (for all groups of the study):

1. With a chronic or acute disease that might interfere with the evaluation of RNS60 therapy.

2. Pregnancy or lactation.

3. Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated).

4. History of infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV).

5. Infections that require intravenous antibiotic therapy.

6. Significant organ dysfunction, including cardiac, renal, liver, CNS, 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).

7. Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry.

8. Treatment with any investigational drugs or therapies within 4 weeks prior to study entry.

9. Any use of antidepressants or other psychiatric medicine in the previous 4 weeks days.

10. Group 1b: Any use of oral, systemic corticosteroids within 2 weeks prior to enrollment. Group 2e: Any use of oral, systemic corticosteroids within 4 weeks prior to enrollment.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• RNS60
RNS60, 4ml nebulized twice daily for 15 minutes.
• RNS60 - single dose
RNS60, single 4 ml dose nebulized for 15 minutes

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Cypress	California
United States	Stanford University	Stanford	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	Forced expiratory volume in 1 second (FEV1)	Evidence that nebulized RNS60 does not cause bronchoconstriction in subjects with mild-to-moderate asthma, as measured by weekly FEV1 scores over 28 days.	28 days
Secondary	Peak expiratory flow	Evidence that nebulized RNS60 does not cause bronchoconstriction in subjects with mild-to-moderate asthma, as measured by peak expiratory flow measured twice daily over 28 days.	28 days
Secondary	Quality of life	Evidence that nebulized RNS60 does not cause a reduced quality of life in subjects with mild-to-moderate asthma, as measured a weekly quality of life questionnaire.	28 days