Asthma Exacerbation and Helium-3 MRI

NCT00846014 | Withdrawn

• 1 other identifier: Docket # 12937
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma Exacerbation

Keywords

asthma; exacerbation; Helium; MRI; Lung imaging

Outcome Measures

Primary Outcomes (1)

• Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months

  1 year

Study Arms (1)

Asthmatics

EXPERIMENTAL

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

Drug: Helium-3

Interventions

Helium-3 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.

Also known as: Hyperpolarized Helium-3

Asthmatics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMASS Medical School Advanced MRI Center

Worcester, Massachusetts, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Helium-3

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mitchell S Albert, Ph.D.

  UMASS Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Advanced MRI Center, UMASS Medical Sch

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: January 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

US (1)