Asthma Clinical Research Network (ACRN) Dose of Inhaled Corticosteroids with Equisystemic Effects (DICE)
Clinical Trials URL:
Study Type: Clinical Trial
Prepared on October 13, 2008
Last Updated on August 24, 2006
Study Dates: 1998-1999
Consent: Unrestricted Consent
Commercial Use Restrictions: No
NHLBI Division: DLD
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information
The goal of this study was to establish a realiable method to evaluate systemic bioavailability and to determine equisystemic effects (microgram dose producing equal systemic cortisol suppression) in inhaled cortocosteriods (ICS).
Inhaled corticosteriods (ICS) are being recommended for treatment of all ages of persistent asthma. The choice of an ICS is often based on convenience or cost factors. However, the potential for adverse systemic effects is not commonly considered. Becuase of these effects, it is important to be able to compare the different available prepareations and delivery systems with respect to both of their systemic effects and their efficacy, in order to determine an optimal asthma treatment strategy.
156 corticosteriod-naive patients with asthmas were recruited as 6 ACRN centers. These patients were approximately distributed by sex (58% male) and by ethnicity (31% minorities).
The ICS and placebo groups were comaparable at baseline with respect to sex, ethnicity, age, and BMI. the most reliable methods of evaluation was the 12-hour plasma cortisol under the curve (AUC) for the hourly overnight plasma cortisol measurements from 8 P.M. to 8 A.M.