Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Number of Participants Being Recruited:
Single / Multi-Center:
STUDY BACKGROUND INFORMATION:
This was a small clinical study to determine whether the inhaled aerosol drugs used to treat cystic fibrosis (CF) might work better if special chemicals, called surfactants, were added to them. Aerosol medications are often given as a liquid mist which deposits on the insides of the lungs after being inhaled bythe patient using a device called a nebulizer. We believed that certain surfactants would cause these medications to spread over the insides of the lungs like soap spreads over water, evenly distributing them throughout the lungs and helping them to reach portions of the lungs that they may not reach otherwise. We believed that the expansions and contractions of the lungs that occur during breathing would help to spread these surfactant based medicines even more. Our goal was to improve the inhaled antibiotics used by people with CF by helping them each more of the infected parts of the lung. These surfactants may also improve other medications used tot reat CF. Our study involved people with and without cystic fibrosis. Volunteers inhaled a surfactant aerosol on one day and a saline (or placebo) aerosol on another. Both aerosols will contain a small amount of a radioactive tracer called Technetium that let us take images showing how the medicine is distributed on the inside of the lungs. These images were compared to see if the surfactant aerosols spread the medication more thoroughly through the lungs.
>= 18 Years
>= 65 Percent Predicted
P. aeruginosa status:
B. cepacia status:
Other Primary Eligibility Requirements:
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
Eight subjects with CF, age 18 years and older were enrolled in this single site cross-over pilot study comparing inhaled administration of saline or a surfactant (calfactant) to assess aerosol distribution in the lung. Subjects randomly received inhaled calfactant on one of two study days and inhaled saline on the other day, separated by 5-14 days. A radioscintigraphy method (an imaging method) was used to track deposition and redistribution. Aerosol distribution was mostly peripheral and similar for saline and surfactant initially. Changes in dispersion over a longer time frame, assessed as whole lung counts after 30 min were also similar. The demonstrated increases in peripheral clearance due to calfactant were not statistically significant.
Both aerosols were well tolerated. No adverse events were associated with the study aerosols.