AsthmaPhase 2NCT02497222
Pilot Study of RNS60 in Allergen-induced Bronchoconstriction
A Phase 2 study testing RNS60 and Normal Saline in people with Asthma, run by Revalesio Corporation at 1 site in United States.
Trial summary
This study evaluates the use of RNS60 in the treatment of asthma examining regional improvements in inflammation using PET imaging. All subjects will be treated with both RNS60 and placebo in a crossover design. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- RNS60 and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jun 2016
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females with mild asthma (as defined by the National Institutes of Health 2002 Guidelines for the Diagnosis and Management of Asthma (2)) with symptoms more than 2 times a week but less than once per day with normal FEV1 (> 80% predicted).
- Clinical history of allergic symptoms to cat or dust mite allergen and demonstrated skin reactivity.
- Subjects must have a lifetime total of less than 5 pack years with no smoking in the previous 5 years.
- Willing and able to give informed consent and adhere to the study protocol requirements.
- Expressed the desire to participate in the study in an interview with the principal investigator (PI).
- Age between 18 and 50 years.
Who cannot join
- Women of childbearing potential who are documented to be pregnant (based on blood beta-human chorionic gonadotropin [HCG] testing) or who are nursing.
- The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks.
- Participation in research study involving a drug or biologic during the 30 days prior to the study.
- Intolerance to albuterol, atropine, or lidocaine.
- Antihistamines within 7 days of the screening visit.
- Known exposure to agents that are associated with pulmonary disease (i.e. asbestos, silica).
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- Presence of other known pulmonary disease, coronary disease, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure (or creatinine > 1.5, if known), history of anaphylaxis, cirrhosis, diabetes mellitus or presence of a significant disease, which in the opinion of the PI would pose a significant risk for the subject or confound the results of the study.
- Use of systemic steroids, increased use of inhaled steroids, use of beta blockers and monoamine oxidase (MAO) inhibitors or a visit for an asthma exacerbation within 1 month of the screening visit.
- A history of asthma-related respiratory failure requiring intubation.
- A history of hospitalization for asthma.
- Subjects with a high possibility of poor compliance with the study as judged by the PI.
- Unresponsive to bronchodilator agents.
- Quantitative skin prick test at or below a dilution level of standardized cat allergen extract of 1:2048 (4.88 BAU/ml) for subjects being challenged with cat allergen.
- Quantitative skin prick test at or below a dilution level of standardized mite allergen extract of 1:2048 (4.88 AU/ml) for subjects being challenged with either mite allergen.
- Subjects who, by participating in any research study, will have a cumulative radiation dose exceeding 50 mSv in the previous year.
- Contraindication to Methacholine challenge testing (heart attack or stroke in last 3 months, uncontrolled hypertension, or known aortic aneurysm).
- Body Mass Index (BMI) > 32.
- Individuals with known allergy or hypersensitivity to FDG will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
About this study
Official title: Pilot Study of RNS60 in Allergen-induced Bronchconstriction
This study evaluates the use of RNS60 in the treatment of asthma examining regional improvements in inflammation using PET imaging. All subjects will be treated with both RNS60 and placebo in a crossover design.
- Conditions
- Asthma
- Being tested
- RNS60, Normal Saline
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNS60Drug
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| RNS60 | Experimental | RNS60 4 ml, inhaled twice daily by nebulization for 21 days. Receives: Drug: RNS60 |
| Normal Saline | Placebo comparator | Normal Saline 4 ml, inhaled twice daily by nebulization for 21 days. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-FDG uptake rate
Comparison of fluorodeoxyglucose (18F-FDG) uptake rate in subjects before and after inhalation of RNS60 or placebo
Measured: 21 days
Secondary outcomes (1)
Regional VA and Vdef volume
Comparison of regional ventilation (VA) and ventilation defective areas (Vdef) volume in subjects before and after inhalation of RNS60 or placebo
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Primary completionJun 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 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
- NCT02497222
- Sponsor's protocol ID
- 01.1.1.H4
- Status last verified
- Oct 2016
- First submitted
- 10 Jul 2015
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of RNS60 in Allergen-induced Bronchconstriction
- ClinicalTrials.gov ID
- NCT02497222
- Acronym / sponsor ID
- 01.1.1.H4
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Revalesio CorporationIndustry (pharma, biotech, devices)
- Primary completion
- Jun 2016 (actual)
- First posted
- 14 Jul 2015 (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.
This study evaluates the use of RNS60 in the treatment of asthma examining regional improvements in inflammation using PET imaging. All subjects will be treated with both RNS60 and placebo in a crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RNS60 | Experimental | Drug: RNS60RNS60 4 ml, inhaled twice daily by nebulization for 21 days. |
| Normal Saline | Placebo comparator | Drug: Normal SalineNormal Saline 4 ml, inhaled twice daily by nebulization for 21 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or females with mild asthma (as defined by the National Institutes of Health 2002 Guidelines for the Diagnosis and Management of Asthma (2)) with symptoms more than 2 times a week but less than once per day with normal FEV1 (> 80% predicted).
- Clinical history of allergic symptoms to cat or dust mite allergen and demonstrated skin reactivity.
- Subjects must have a lifetime total of less than 5 pack years with no smoking in the previous 5 years.
- Willing and able to give informed consent and adhere to the study protocol requirements.
- Expressed the desire to participate in the study in an interview with the principal investigator (PI).
Key exclusion criteria (18 listed)
- Women of childbearing potential who are documented to be pregnant (based on blood beta-human chorionic gonadotropin [HCG] testing) or who are nursing.
- The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks.
- Participation in research study involving a drug or biologic during the 30 days prior to the study.
- Intolerance to albuterol, atropine, or lidocaine.
- Antihistamines within 7 days of the screening visit.
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 |
|---|---|---|
| RNS60 | Drug | RNS60 |
| Normal Saline | Drug | Normal Saline |
Primary outcome
18F-FDG uptake rate
Time frame: 21 days
Comparison of fluorodeoxyglucose (18F-FDG) uptake rate in subjects before and after inhalation of RNS60 or placebo
1 secondary outcome
Regional VA and Vdef volume
Time frame: 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RNS60 and Normal Saline in people with Asthma, run by Revalesio Corporation at 1 site 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 6 inclusion and 18 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: withdrawn, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
18F-FDG uptake rate (time frame: 21 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 4 Oct 2016.