Asthma Exacerbation and Helium-3 MRI

Asthma Exacerbation Clinical Trial

Official title:

Asthma Exacerbation and Helium-3 MRI

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00846014
• Other study ID #: Docket # 12937
• Status: Withdrawn
• Phase: N/A
• First received: February 16, 2009
• Last updated: September 18, 2012
• Start date: January 2009
• Est. completion date: August 2011

Study information

• Verified date: September 2012
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• Asthma Exacerbation

Intervention

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.

Locations

Country	Name	City	State
United States	UMASS Medical School Advanced MRI Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months		1 year	No