AsthmaPhase 1NCT01057498
Safety Study of Nebulized RNS60 to Treat Asthma.
A Phase 1 study testing RNS60 and RNS60 - single dose in people with Asthma, run by Revalesio Corporation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- RNS60 and RNS60 - single dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
West Coast Clinical Trials
Cypress, California, 90630
Stanford University
Stanford, California, 94304
About this study
Official title: A Phase I Study of Nebulized RNS60 in Adult Healthy Subjects and Patients With Mild to Moderate Asthma.
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.
- Conditions
- Asthma
- Being tested
- RNS60, RNS60 - single dose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNS60Drug
RNS60, 4ml nebulized twice daily for 15 minutes.
RNS60 - single doseDrug
RNS60, single 4 ml dose nebulized for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1a - RNS60 in Healthy Subjects | Experimental | Single dose administration of nebulized RNS60 testing for bronchoconstriction in healthy human subjects. Receives: Drug: RNS60 - single dose |
| 1b: RNS60 in Mild Asthmatics | Experimental | Single-dose administration of nebulized RNS60 testing for bronchoconstriction in mild asthmatics. Receives: Drug: RNS60 - single dose |
| 2e: RNS60 in mild-to-moderate asthmatics | Experimental | RNS60 in mild-to-moderate asthmatics who are not currently taking a chronic asthma medication. Receives: Drug: RNS60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (2)
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.
Measured: 28 days
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revalesio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kari C Nadeau, M.D., Ph.D., Principal investigator, Stanford UniversityRichard L Watson, M.D., Study director, Revalesio Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057498
- Sponsor's protocol ID
- 01.1.1.H1
- Status last verified
- Jan 2012
- First submitted
- 25 Jan 2010
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Nebulized RNS60 in Adult Healthy Subjects and Patients With Mild to Moderate Asthma.
- ClinicalTrials.gov ID
- NCT01057498
- Acronym / sponsor ID
- 01.1.1.H1
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Revalesio CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1a - RNS60 in Healthy Subjects | Experimental | Drug: RNS60 - single doseSingle dose administration of nebulized RNS60 testing for bronchoconstriction in healthy human subjects. |
| 1b: RNS60 in Mild Asthmatics | Experimental | Drug: RNS60 - single doseSingle-dose administration of nebulized RNS60 testing for bronchoconstriction in mild asthmatics. |
| 2e: RNS60 in mild-to-moderate asthmatics | Experimental | Drug: RNS60RNS60 in mild-to-moderate asthmatics who are not currently taking a chronic asthma medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNS60RNS60, 4ml nebulized twice daily for 15 minutes. | Drug | 2e: RNS60 in mild-to-moderate asthmatics |
| RNS60 - single doseRNS60, single 4 ml dose nebulized for 15 minutes | Drug | 1a - RNS60 in Healthy Subjects, 1b: RNS60 in Mild Asthmatics |
Primary outcome
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.
2 secondary outcomes
Peak expiratory flow
Time frame: 28 days
Quality of life
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari C Nadeau, M.D., Ph.D. principal investigator
Stanford University
Richard L Watson, M.D. study director
Revalesio Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RNS60 and RNS60 - single dose in people with Asthma, run by Revalesio Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in 1 second (FEV1) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.