AsthmaPhase 1NCT01511302
Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma
A Phase 1 study testing RNS60, Normal Saline and Budesonide in people with Asthma, run by Revalesio Corporation at 4 sites in United States.
Trial summary
The purpose of this study is to determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- RNS60, Normal Saline and Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2012to May 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female non-smokers, aged between 18 and 65 years.
- Clinical diagnosis of mild to moderate asthma meeting NHLBI 2007 guidelines as outlined in Appendix A.
- Subjects who have a currently prescribed inhaled corticosteroid medication to treat asthma, alone or in combination with other medications, with usage of 1 month (≥ 95% compliance) or more on the inhaled corticosteroid treatment.
- Normal 12-lead ECG at Screening.
- Normal single view chest x-ray at Screening.
- Men and women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment (Day 57).
- Women of childbearing potential who have a negative pregnancy test (serum HCG) at the time of study entry, and again on Day 22.
- 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
- Chronic or acute disease that might interfere with the evaluation of RNS60.
- Pregnancy, intent to become pregnant, or breastfeeding.
- Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated).
- Positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody.
- Positive urine drug screen (UDS) for drugs of abuse including alcohol and cotinine at the time of study entry and again on Day 22.
- Infections that require intravenous antibiotic therapy.
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- Significant organ dysfunction, including cardiac, renal, liver, central nervous system, 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, therapies, or medical devices within 4 weeks prior to study entry.
- Any use of antidepressants or other psychiatric medicine within 4 weeks prior to study entry and/or during the study treatment period.
- Use of any over-the-counter asthma treatments, including Primatene Mist, during the 8-week active study period.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
West Coast Clinical Trials
Costa Mesa, California, 92626
California Allergy and Asthma
Los Angeles, California, 90025
Axis Clinical Trials
Los Angeles, California, 90036
Integrated Research Group
Riverside, California, 92506
About this study
Official title: A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma
The purpose of this study is to determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period.
- Conditions
- Asthma
- Being tested
- RNS60, Normal Saline, Budesonide
- 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, 2ml, nebulized twice daily.
Normal SalineDrug
Normal Saline placebo, 2 ml, nebulized twice daily.
BudesonideDrug
Budesonide, in either 0.25 mg or 0.5 mg per 2 ml concentration in liquid suspension, nebulized once per day in combination with RNS60 or NS.
| Study group | Role | What they receive |
|---|---|---|
| RNS60-BD 0.25 | Experimental | RNS60 in combination with Budesonide 0.25mg/2ml concentration Receives: Drug: RNS60; Drug: Budesonide |
| RNS60-BD 0.5 | Experimental | RNS60 in combination with Budesonide 0.5mg/2ml concentration Receives: Drug: RNS60; Drug: Budesonide |
| NS-BD 0.5 | Placebo comparator | Normal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration Receives: Drug: Normal Saline; Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced expiratory volume in 1 second (FEV1)
Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores.
Measured: Baseline to 56 days
Secondary outcomes (3)
Change in peak expiratory flow
Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by daily peak expiratory flow values.
Measured: Baseline to 56 days
Change in quality of life
Evidence that RNS60 in combination with budesonide does not reduce patient's quality of life, as measured by weekly QOL questionnaire over 28 days.
Measured: 56 days
Change in rescue inhaler usage
Evidence that RNS60 in combination with budesonide does not increase rescue inhaler usage, as measured by patient diary.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionMay 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revalesio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511302
- Sponsor's protocol ID
- 01.1.1.H2
- Status last verified
- Jul 2014
- First submitted
- 12 Jan 2012
- Last updated
- 28 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT01511302
- Acronym / sponsor ID
- 01.1.1.H2
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Revalesio CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 Jan 2012 (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 to determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RNS60-BD 0.25 | Experimental | Drug: RNS60, Drug: BudesonideRNS60 in combination with Budesonide 0.25mg/2ml concentration |
| RNS60-BD 0.5 | Experimental | Drug: RNS60, Drug: BudesonideRNS60 in combination with Budesonide 0.5mg/2ml concentration |
| NS-BD 0.5 | Placebo comparator | Drug: Normal Saline, Drug: BudesonideNormal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female non-smokers, aged between 18 and 65 years.
- Clinical diagnosis of mild to moderate asthma meeting NHLBI 2007 guidelines as outlined in Appendix A.
- Subjects who have a currently prescribed inhaled corticosteroid medication to treat asthma, alone or in combination with other medications, with usage of 1 month (≥ 95% compliance) or more on the inhaled corticosteroid treatment.
- Normal 12-lead ECG at Screening.
- Normal single view chest x-ray at Screening.
Key exclusion criteria (11 listed)
- Chronic or acute disease that might interfere with the evaluation of RNS60.
- Pregnancy, intent to become pregnant, or breastfeeding.
- Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated).
- Positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody.
- Positive urine drug screen (UDS) for drugs of abuse including alcohol and cotinine at the time of study entry and again on Day 22.
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, 2ml, nebulized twice daily. | Drug | RNS60-BD 0.25, RNS60-BD 0.5 |
| Normal SalineNormal Saline placebo, 2 ml, nebulized twice daily. | Drug | NS-BD 0.5 |
| BudesonideBudesonide, in either 0.25 mg or 0.5 mg per 2 ml concentration in liquid suspension, nebulized once per day in combination with RNS60 or NS. | Drug | NS-BD 0.5, RNS60-BD 0.25, RNS60-BD 0.5 |
Primary outcome
Change in Forced expiratory volume in 1 second (FEV1)
Time frame: Baseline to 56 days
Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores.
3 secondary outcomes
Change in peak expiratory flow
Time frame: Baseline to 56 days
Change in quality of life
Time frame: 56 days
Change in rescue inhaler usage
Time frame: 56 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 28 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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, Normal Saline and Budesonide in people with Asthma, run by Revalesio Corporation at 4 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 8 inclusion and 11 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 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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?
Change in Forced expiratory volume in 1 second (FEV1) (time frame: Baseline to 56 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 28 Jul 2014.