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Asthma Exacerbation and Helium-3 MRI

NCT ID: NCT00846014

Last Updated: 2012-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-08-31

Brief Summary

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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

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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

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Asthma Exacerbation

Keywords

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asthma exacerbation Helium MRI Lung imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Asthmatics

All subjects will be asthmatics that have had an exacerbation (asthma attack) no more than 48 hours before the imaging session.

Group Type EXPERIMENTAL

Helium-3

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Hyperpolarized Helium-3

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Mitchell Albert

Director of Advanced MRI Center, UMASS Medical Sch

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mitchell S Albert, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UMASS Medical School

Locations

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UMASS Medical School Advanced MRI Center

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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Docket # 12937

Identifier Type: -

Identifier Source: org_study_id