Imaging Study of the Lungs During an Allergic Asthma Attack

NACompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
AsthmaAtopy
Interventions
BIOLOGICAL

Standardized Cat Allergen Extract and Standardized Dust Mite Allergen

The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated provocative concentration of allergen that causes a 20% fall in Forced Expired Volume in 1 second delivered for 5 minutes at tidal breathing, followed by Forced Expired Volume in 1 second at 10-minute intervals until the lowest Forced Expired Volume in 1 second is established. If the percent of Forced Expired Volume in 1 second fall is \< 20%, the next concentration is given, until the Forced Expired Volume in 1 second falls ≥ 20 percent. When this happens the Forced Expired Volume in 1 second will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum percent of Forced Expired Volume in 1 second fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.

RADIATION

Computed Tomography imaging, functional Positron Emission Tomography imaging

Physiology study using Computed Tomography and Positron Emission Tomography imaging with Nitrogen-13 saline as radiotracer; images obtained during the early and late phases after allergen challenge

DRUG

Nebulized methacholine inhalation

Standard methacholine challenge performed once to determine the subject's dose that causes a 20% fall in Forced Expired Volume in 1 second from baseline.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Massachusetts General Hospital

OTHER

NCT01547286 - Imaging Study of the Lungs During an Allergic Asthma Attack | Biotech Hunter | Biotech Hunter