- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057498
Safety Study of Nebulized RNS60 to Treat Asthma.
A Phase I Study of Nebulized RNS60 in Adult Healthy Subjects and Patients With Mild to Moderate Asthma.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- West Coast Clinical Trials
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Stanford, California, United States, 94304
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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):
- Male or female, aged 18 to 65 years.
- Patients with clinical diagnosis of mild to moderate asthma, as determined by NHLBI 2007 guidelines, who are not already using a chronic asthma medication.
- Historical documentation of asthma in the patient's medical record.
- 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).
- Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry.
- 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):
- With a chronic or acute disease that might interfere with the evaluation of RNS60 therapy.
- Pregnancy or lactation.
- Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated).
- History of infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV).
- Infections that require intravenous antibiotic therapy.
- 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).
- Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry.
- Treatment with any investigational drugs or therapies within 4 weeks prior to study entry.
- Any use of antidepressants or other psychiatric medicine in the previous 4 weeks days.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1a - RNS60 in Healthy Subjects
Single dose administration of nebulized RNS60 testing for bronchoconstriction in healthy human subjects.
|
RNS60, single 4 ml dose nebulized for 15 minutes
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EXPERIMENTAL: 1b: RNS60 in Mild Asthmatics
Single-dose administration of nebulized RNS60 testing for bronchoconstriction in mild asthmatics.
|
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.
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RNS60, 4ml nebulized twice daily for 15 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
28 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kari C Nadeau, M.D., Ph.D., Stanford University
- Study Director: Richard L Watson, M.D., Revalesio Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Pharmaceutical Solutions
- RNS60
Other Study ID Numbers
- 01.1.1.H1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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