Asthma Exacerbation and Helium-3 MRI

University of Massachusetts, Worcester

Status: Withdrawn

Conditions: Asthma Exacerbation

Treatments: Drug: Helium-3

Study type: Interventional

Funder types: Other

Identifiers

NCT00846014

Docket # 12937

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Asthmatics

Experimental group

Description:

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

Treatment:

Drug: Helium-3