A randomized placebo-controlled study of intravenous montelukast for the treatment of acute asthma.
BACKGROUND
Current treatments for acute asthma provide inadequate benefit for some patients. Intravenous montelukast may complement existent therapies.


OBJECTIVE
To evaluate efficacy of intravenous montelukast as adjunctive therapy for acute asthma.


METHODS
A total of 583 adults with acute asthma were treated with standard care during a < or = 60-minute screening period. Patients with FEV(1) < or =50% predicted were randomly allocated to intravenous montelukast 7 mg (n = 291) or placebo (n = 292) in addition to standard care. This double-blind treatment period lasted until a decision for discharge, hospital admission, or discontinuation from the study. The primary efficacy endpoint was the time-weighted average change in FEV(1) during 60 minutes after drug administration. Secondary endpoints included the time-weighted average change in FEV(1) at various intervals (10-120 minutes) and percentage of patients with treatment failure (defined as hospitalization or lack of decision to discharge by 3 hours postadministration).


RESULTS
Montelukast significantly increased FEV(1) at 60 minutes postdose; the difference between change from baseline for placebo (least-squares mean of 0.22 L; 95% CI, 0.17, 0.27) and montelukast (0.32 L; 95% CI, 0.27, 0.37) was 0.10 L (95% CI, 0.04, 0.16). Similar improvements in FEV(1)-related variables were seen at all time points (all P <.05). Although treatment failure did not differ between groups (OR 0.92; 95% CI, 0.63, 1.34), a prespecified subgroup analysis suggests likely benefit for intravenous montelukast at US sites.


CONCLUSIONS
Intravenous montelukast added to standard care in adults with acute asthma produced significant relief of airway obstruction throughout the 2 hours after administration, with an onset of action as early as 10 minutes.
Camargo
Carlos A
CA
Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. ccamargo@partners.org
Gurner
Deborah M
DM
Smithline
Howard A
HA
Chapela
Rocio
R
Fabbri
Leonardo M
LM
Green
Stuart A
SA
Malice
Marie-Pierre
MP
Legrand
Catherine
C
Dass
S Balachandra
SB
Knorr
Barbara A
BA
Reiss
Theodore F
TF
D000085:Acetates / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000008:administration & dosage*; D012129:Respiratory Function Tests; D013440:Sulfides; D055815:Young Adult
D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast