Safety Study of Nebulized RNS60 to Treat Asthma.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Revalesio Corporation
ClinicalTrials.gov Identifier:
NCT01057498
First received: January 25, 2010
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: RNS60
Drug: RNS60 - single dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Nebulized RNS60 in Adult Healthy Subjects and Patients With Mild to Moderate Asthma.

Resource links provided by NLM:


Further study details as provided by Revalesio Corporation:

Primary Outcome Measures:
  • Forced expiratory volume in 1 second (FEV1) [ Time Frame: 28 days ]
    Evidence that nebulized RNS60 does not cause bronchoconstriction in subjects with mild-to-moderate asthma, as measured by weekly FEV1 scores over 28 days.


Secondary Outcome Measures:
  • Peak expiratory flow [ Time Frame: 28 days ]
    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.

  • Quality of life [ Time Frame: 28 days ]
    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.


Enrollment: 36
Study Start Date: May 2010
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1a - RNS60 in Healthy Subjects
Single dose administration of nebulized RNS60 testing for bronchoconstriction in healthy human subjects.
Drug: RNS60 - single dose
RNS60, single 4 ml dose nebulized for 15 minutes
Experimental: 1b: RNS60 in Mild Asthmatics
Single-dose administration of nebulized RNS60 testing for bronchoconstriction in mild asthmatics.
Drug: RNS60 - single dose
RNS60, single 4 ml dose nebulized for 15 minutes
Experimental: 2e: RNS60 in mild-to-moderate asthmatics
RNS60 in mild-to-moderate asthmatics who are not currently taking a chronic asthma medication.
Drug: RNS60
RNS60, 4ml nebulized twice daily for 15 minutes.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057498

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Stanford University
Stanford, California, United States, 94304
Sponsors and Collaborators
Revalesio Corporation
Investigators
Principal Investigator: Kari C Nadeau, M.D., Ph.D. Stanford University
Study Director: Richard L Watson, M.D. Revalesio Corporation
  More Information

No publications provided

Responsible Party: Revalesio Corporation
ClinicalTrials.gov Identifier: NCT01057498     History of Changes
Other Study ID Numbers: 01.1.1.H1
Study First Received: January 25, 2010
Last Updated: January 11, 2012
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

ClinicalTrials.gov processed this record on April 22, 2014