The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial.
BACKGROUND
Although guidelines recommend anti-inflammatory therapy for persistent asthma, recent studies suggest that 25% to 35% of patients with asthma may not improve lung function with inhaled corticosteroids.


OBJECTIVE
To evaluate potential biomarkers of predicting short-term (6-week) response to inhaled corticosteroid with subsequent evaluation of responders and nonresponders to asthma control over a longer interval (16 additional weeks).


METHODS
Eighty-three subjects with asthma off steroid were enrolled in this multicenter study. Biomarkers and asthma characteristics were evaluated as predictors of inhaled corticosteroid response over a 6-week trial for changes in FEV(1) and methacholine PC(20). After this, an additional 4-month trial evaluated asthma control.


RESULTS
Although multiple baseline predictors had significant correlations with improvements for short-term inhaled steroid success, the only strong correlations (r >or= +/- 0.6) were albuterol reversibility (r = 0.83; P < .001), FEV(1)/forced vital capacity (r = -0.75; P < .001), and FEV(1) % predicted (r = -0.71; P < .001). Dividing the subjects in the short-term inhaled steroid trial into responders (>5% FEV(1) improvement) and nonresponders (<or=5%) determined the longer-term need for steroids. For the nonresponders, asthma control remained unchanged whether inhaled corticosteroids were continued or were substituted with a placebo (P = .99). The good short-term responders maintained asthma control longer-term only if maintained on inhaled steroids (P = .007).


CONCLUSIONS
The short-term response to inhaled corticosteroids with regard to FEV(1) improvement predicts long-term asthma control.


CONCLUSIONS
The decision to use long-term inhaled steroids could be based on a short-term trial. Different therapeutic strategies would need to be established for nonresponders.
Martin
Richard J
RJ
National Jewish Medical and Research Center, Denver, CO 80206, USA. martinr@njc.org
Szefler
Stanley J
SJ
King
Tonya S
TS
Kraft
Monica
M
Boushey
Homer A
HA
Chinchilli
Vernon M
VM
Craig
Timothy J
TJ
Dimango
Emily A
EA
Deykin
Aaron
A
Fahy
John V
JV
Israel
Elliot
E
Lazarus
Stephen C
SC
Lemanske
Robert F
RF
Leone
Frank T
FT
Pesola
Gene R
GR
Peters
Stephen P
SP
Sorkness
Christine A
CA
Szwejbka
Lisa A
LA
Wechsler
Michael E
ME
D000328:Adult; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000627:therapeutic use*; D015415:Biomarkers; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D018927:Anti-Asthmatic Agents; D015415:Biomarkers; D001507:Beclomethasone