Bronchodilator efficacy of the fixed combination of ipratropium and albuterol compared to albuterol alone in moderate-to-severe persistent asthma.
BACKGROUND
The potential of anticholinergics to provide bronchodilatory benefits over short-acting beta(2)-agonists (SABA) alone in patients with moderate-to-severe persistent asthma has not been well defined.


METHODS
An outpatient, randomized, double-blind, single-dose, crossover study in adult asthmatics with moderate-to-severe obstruction despite treatment with inhaled corticosteroids (ICS) was conducted comparing the fixed combination of ipratropium and albuterol (IB+ALB) to albuterol alone (ALB). Serial spirometry was performed over 6h. SABA were withheld for 8h, ICS and LABA for 24h.


RESULTS
A total of 113 patients were randomized, 106 completed the study (males n=47; mean+/-SD age=51+/-13 years). Mean+/-SD baseline FEV(1)=1.4+/-0.5 L (49+/-12% predicted). IB+ALB resulted in significantly greater improvements over ALB in the average improvement over baseline in FEV(1) as approximated from the area under the curve from 0 to 6h after drug administration (72 ml, p<0.01) and mean peak FEV(1) response (55 ml, p<0.01) as well as higher FEV(1) responses at individual time points from 0.5 to 6h postdose (p<0.01 for all). Time to onset of response was similar between groups but time to peak and duration of response were longer with IB+ALB versus ALB (120 versus 60 min and 245 versus 106 min, respectively).


CONCLUSIONS
IB+ALB resulted in significantly greater improvement in FEV(1) and longer duration of response compared to ALB alone in patients with moderate-to-severe persistent asthma (Trial number: 1012.50; ClinicalTrial.gov NCT00096616).
Gelb
Arthur F
AF
Pulmonary Division, Lakewood Regional Medical Center, Lakewood, CA, USA. afgelb@msn.com
Karpel
Jill
J
Wise
Robert A
RA
Cassino
Cara
C
Johnson
Philip
P
Conoscenti
Craig S
CS
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000008:administration & dosage* / Q000627:therapeutic use; D019540:Area Under Curve; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D013147:Spirometry; D013997:Time Factors; D055815:Young Adult
D001993:Bronchodilator Agents; D004338:Drug Combinations; D009241:Ipratropium; D000420:Albuterol