Asthma Exacerbation and Helium-3 MRI

September 18, 2012 updated by: Mitchell Albert, University of Massachusetts, Worcester
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States
        • UMASS Medical School Advanced MRI Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Asthmatics
All subjects will be asthmatics that have had an exacerbation (asthma attack) no more than 48 hours before the imaging session.
Drug: 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.
Other Names:
  • Hyperpolarized Helium-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

February 16, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (ESTIMATE)

February 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Docket # 12937

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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