AsthmaEarly Phase 1NCT02306473
The Leaky Lung Test
A Early Phase 1 study testing Mannitol in people with Asthma and Allergy, run by University of Rochester at 1 site in United States.
Trial summary
This is a clinical trial designed to test the hypothesis that measuring the absorption and excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial permeability in asthma. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergy, Reactive Airway Disease
- What is being tested?
- Mannitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 1 Dec 2017
- Phase
- Early 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- >5 pack year history of tobacco use or active smoking.
- Other chronic or active lung diseases (e.g. COPD, pulmonary fibrosis, lung cancer)
- History of significant renal insufficiency of liver disease
- Asthma subjects with severe disease according to NAEPP guidelines (e.g. severe ongoing symptoms despite high-dose inhaled or oral glucocorticoids)
- Asthma subjects with a baseline FEV1<65% predicted
- Asthma subjects unwilling or unable to withhold medications prior to testing
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Novel Non-invasive Way to Measure Airway Epithelial Permeability in Human Subjects
This is a clinical trial designed to test the hypothesis that measuring the absorption and excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial permeability in asthma.
Read the detailed description
A cohort of subjects with asthma and healthy controls will be exposed to inhaled mannitol according to FDA approved protocols for bronchoprovocation. Mannitol will be measured in the bloodstream and urine and used to determine an airway permeability index. This is a proof of concept study and not a trial of new therapeutics.
- Conditions
- Asthma, Allergy, Reactive Airway Disease, Lung Diseases, Obstructive
- Being tested
- Mannitol
- Medical subject headings
- Asthma, Hypersensitivity, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Also called Aridol for bronchoprovocation
Subjects will be challenged with inhaled mannitol according to already approved protocols.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Experimental | Subjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols. Receives: Drug: Mannitol |
| Controls | Experimental | Healthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols. Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway permeability index (Urinary clearance of mannitol overtime)
Urinary clearance of mannitol overtime
Measured: 24 hours
Secondary outcomes (1)
Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)
Absorption and clearance of mannitol from the bloodstream
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startOct 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Syntara, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Steve Nicholas Georas, University of Rochester
- Investigators
- Steve N Georas, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306473
- Sponsor's protocol ID
- RSRB00043414
- Other IDs
- R01HL122424
- Status last verified
- Jan 2018
- First submitted
- 1 Dec 2014
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Non-invasive Way to Measure Airway Epithelial Permeability in Human Subjects
- ClinicalTrials.gov ID
- NCT02306473
- Acronym / sponsor ID
- RSRB00043414
- Conditions
- Asthma, Allergy, Reactive Airway Disease, Lung Diseases, Obstructive
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Syntara, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2015
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 3 Dec 2014 (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 is a clinical trial designed to test the hypothesis that measuring the absorption and excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial permeability in asthma.
Detailed description
A cohort of subjects with asthma and healthy controls will be exposed to inhaled mannitol according to FDA approved protocols for bronchoprovocation. Mannitol will be measured in the bloodstream and urine and used to determine an airway permeability index. This is a proof of concept study and not a trial of new therapeutics.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | Experimental | Drug: MannitolSubjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols. |
| Controls | Experimental | Drug: MannitolHealthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- >5 pack year history of tobacco use or active smoking.
- Other chronic or active lung diseases (e.g. COPD, pulmonary fibrosis, lung cancer)
- History of significant renal insufficiency of liver disease
- Asthma subjects with severe disease according to NAEPP guidelines (e.g. severe ongoing symptoms despite high-dose inhaled or oral glucocorticoids)
- Asthma subjects with a baseline FEV1<65% predicted
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 |
|---|---|---|
| MannitolAlso: Aridol for bronchoprovocationSubjects will be challenged with inhaled mannitol according to already approved protocols. | Drug | Asthma, Controls |
Primary outcome
Airway permeability index (Urinary clearance of mannitol overtime)
Time frame: 24 hours
Urinary clearance of mannitol overtime
1 secondary outcome
Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)
Time frame: 6 hours
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 4 Jan 2018.
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Asthma
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.
Steve N Georas, M.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mannitol in people with Asthma and Allergy, run by University of Rochester 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 0 inclusion and 7 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 4 Jan 2018. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Airway permeability index (Urinary clearance of mannitol overtime) (time frame: 24 hours). 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 Jan 2018.