Asthma ExacerbationNCT00846014
Asthma Exacerbation and Helium-3 MRI
A study testing Helium-3 in people with Asthma Exacerbation, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this research is to use Helium-3 MRI to see the changes in airflow of the lungs at different times of an attack. These three stages are immediately after the attack, 1 month later and 4-6 months later. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Exacerbation
- What is being tested?
- Helium-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Aug 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Able to speak and read English
- Acute asthma exacerbation, defined as requirement for hospitalization or emergent outpatient visit, and treatment with high dose corticosteroids ( 40mg prednisone or equivalent)
- FEV1 < 80% predicted on the day of MRI
- Attending physician agrees that patient is safe to participate on the day of the MRI scan
Who cannot join
- Evidence of pneumonia, based on chest radiograph obtained within 24 hours of enrollment (if performed)
- Documented fever or requirement for antibiotics
- Unable to hold breath for 10 seconds
- Active smoker or history of at least 10 pack years cigarette smoking
- Chest radiograph with active pulmonary disease, except for changes expected with asthma (hyperinflation, subsegmental atelectasis)
- Admission to ICU
Show all 11Show fewer
- For inpatients: contraindication to leaving hospital room for MRI as determined by Attending physician and RN on day of MRI
- Any other concurrent active pulmonary disease or other unstable or active medical condition (including suspected active coronary ischemia, acute bleeding), as determined by Attending physician
- Pregnancy as self reported
- Need for cardiac monitoring
- Need supplemental oxygen at an amount of 4L/min or a facemask
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS Medical School Advanced MRI Center
Worcester, Massachusetts
About this study
The goal of this research is to use Helium-3 MRI to see the changes in airflow of the lungs at different times of an attack. These three stages are immediately after the attack, 1 month later and 4-6 months later.
Read the detailed description
Asthma is a pulmonary disorder that affects millions of people each year. The exact method of exacerbation is still under some discussion. Currently there is no cure for the disorder but treatment is of a wide variety.
This study is meant to image the asthmatic lung at various time points post exacerbation. Since pulmonary imaging is currently limited to radiation techniques, this method will allow exacerbated images without the unnecessary exposure to radiation.
- Conditions
- Asthma Exacerbation
- Being tested
- Helium-3
- Keywords
- asthma, exacerbation, Helium, MRI, Lung imaging
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helium-3Drug
Also called Hyperpolarized Helium-3
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. Then three additional bags will be administered, again with five to ten minutes between each bag.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatics | Experimental | All subjects will be asthmatics that have had an exacerbation (asthma attack) no more than 48 hours before the imaging session. Receives: Drug: Helium-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Subjects which fit the strict inclusion criteria were not found.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ExacerbationStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitchell Albert, University of Massachusetts, Worcester
- Investigators
- Mitchell S Albert, Ph.D., Principal investigator, UMASS Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846014
- Sponsor's protocol ID
- Docket # 12937
- Status last verified
- Sep 2012
- First submitted
- 16 Feb 2009
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Exacerbation and Helium-3 MRI
- ClinicalTrials.gov ID
- NCT00846014
- Acronym / sponsor ID
- Docket # 12937
- Conditions
- Asthma Exacerbation
- Keywords
- asthma, exacerbation, Helium, MRI, Lung imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subjects which fit the strict inclusion criteria were not found.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 18 Feb 2009 (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 goal of this research is to use Helium-3 MRI to see the changes in airflow of the lungs at different times of an attack. These three stages are immediately after the attack, 1 month later and 4-6 months later.
Detailed description
Asthma is a pulmonary disorder that affects millions of people each year. The exact method of exacerbation is still under some discussion. Currently there is no cure for the disorder but treatment is of a wide variety.
This study is meant to image the asthmatic lung at various time points post exacerbation. Since pulmonary imaging is currently limited to radiation techniques, this method will allow exacerbated images without the unnecessary exposure to radiation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatics | Experimental | Drug: Helium-3All subjects will be asthmatics that have had an exacerbation (asthma attack) no more than 48 hours before the imaging session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Able to speak and read English
- Acute asthma exacerbation, defined as requirement for hospitalization or emergent outpatient visit, and treatment with high dose corticosteroids ( 40mg prednisone or equivalent)
- FEV1 < 80% predicted on the day of MRI
- Attending physician agrees that patient is safe to participate on the day of the MRI scan
Key exclusion criteria (11 listed)
- Evidence of pneumonia, based on chest radiograph obtained within 24 hours of enrollment (if performed)
- Documented fever or requirement for antibiotics
- Unable to hold breath for 10 seconds
- Active smoker or history of at least 10 pack years cigarette smoking
- Chest radiograph with active pulmonary disease, except for changes expected with asthma (hyperinflation, subsegmental atelectasis)
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 |
|---|---|---|
| Helium-3Also: Hyperpolarized Helium-3Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. Then three additional bags will be administered, again with five to ten minutes between each bag. | Drug | Asthmatics |
Primary outcome
Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months
Time frame: 1 year
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 20 Sep 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.
Mitchell S Albert, Ph.D. principal investigator
UMASS Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helium-3 in people with Asthma Exacerbation, run by University of Massachusetts, Worcester 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 5 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: withdrawn, as of the sponsor's last update on 20 Sep 2012. 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.
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?
Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months (time frame: 1 year). 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 20 Sep 2012.