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Safety Study of Nebulized RNS60 to Treat Asthma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01057498
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
Revalesio Corporation

Tracking Information
First Submitted Date  ICMJE January 25, 2010
First Posted Date  ICMJE January 27, 2010
Last Update Posted Date January 12, 2012
Study Start Date  ICMJE May 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
Evidence that nebulized RNS60 in combination with budesonide, does not cause bronchoconstriction in healthy subjects or subjects with mild-to-moderate asthma, as measured by FEV1 measurements. [ Time Frame: 9 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Nebulized RNS60 to Treat Asthma.
Official Title  ICMJE A Phase I Study of Nebulized RNS60 in Adult Healthy Subjects and Patients With Mild to Moderate Asthma.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: RNS60
    RNS60, 4ml nebulized twice daily for 15 minutes.
  • Drug: RNS60 - single dose
    RNS60, single 4 ml dose nebulized for 15 minutes
Study Arms  ICMJE
  • Experimental: 1a - RNS60 in Healthy Subjects
    Single dose administration of nebulized RNS60 testing for bronchoconstriction in healthy human subjects.
    Intervention: Drug: RNS60 - single dose
  • Experimental: 1b: RNS60 in Mild Asthmatics
    Single-dose administration of nebulized RNS60 testing for bronchoconstriction in mild asthmatics.
    Intervention: Drug: RNS60 - single dose
  • Experimental: 2e: RNS60 in mild-to-moderate asthmatics
    RNS60 in mild-to-moderate asthmatics who are not currently taking a chronic asthma medication.
    Intervention: Drug: RNS60
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2012)
36
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2010)
90
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057498
Other Study ID Numbers  ICMJE 01.1.1.H1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Revalesio Corporation
Study Sponsor  ICMJE Revalesio Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kari C Nadeau, M.D., Ph.D. Stanford University
Study Director: Richard L Watson, M.D. Revalesio Corporation
PRS Account Revalesio Corporation
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP