CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Standardized Cat Allergen Extract and Standardized Dust Mite Allergen +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01547286
NCT01547286N/ACompleted

Redistribution of Pulmonary Perfusion During Bronchoconstriction in Asthma

Massachusetts General Hospital·interventional·Posted Mar 7, 2012·Updated Nov 22, 2017

In Brief

A clinical study evaluating Standardized Cat Allergen Extract and Standardized Dust Mite Allergen, Computed Tomography imaging, functional Positron Emission Tomography imaging, and 1 other intervention for Asthma and Atopy. Completed, enrolled 7 participants across 1 site.

Detailed Summary

Asthma is a disease of rapidly increasing incidence that already affects more than 17 million people in the United States alone. It has long been known that areas of severely reduced airflow occur in asthma and contribute significantly to the impairment of gas exchange in this disease. However, the extent to which local blood flow changes during an asthmatic attack is unclear. The purpose of this study is using Positron Emission Tomography - Computed Tomography imaging to evaluate how the blood flow changes in the lungs during an asthma attack induced by allergens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Atopy
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2012
Enrollment StartMay 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.3 years ago

Interventions

Standardized Cat Allergen Extract and Standardized Dust Mite Allergenbiological

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.

Computed Tomography imaging, functional Positron Emission Tomography imagingradiation

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

Nebulized methacholine inhalationdrug

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.