The Efficacy and Tolerability of Intravenous Montelukast in Acute Asthma Exacerbations in Japanese Patients
| Autor: | Takaaki Ishine, Yuji Tohda, Steven S. Smugar, Mitsuru Adachi, Yasuyuki Sano, Satoru Hisada, Hiroyuki Taniguchi |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Adult
Cyclopropanes Male Pulmonary and Respiratory Medicine Adolescent Acetates Sulfides Placebo law.invention Young Adult Asian People Double-Blind Method Randomized controlled trial immune system diseases law Forced Expiratory Volume Clinical endpoint Humans Immunology and Allergy Medicine Anti-Asthmatic Agents Infusions Intravenous Montelukast Aged Asthma business.industry Middle Aged medicine.disease respiratory tract diseases Clinical trial Treatment Outcome Tolerability Anesthesia Pediatrics Perinatology and Child Health Quinolines Leukotriene Antagonists Female Aminophylline business medicine.drug |
| Zdroj: | Journal of Asthma. 49:649-656 |
| ISSN: | 1532-4303 0277-0903 |
| DOI: | 10.3109/02770903.2012.690479 |
| Popis: | In Japan, the Asthma Prevention and Management Guidelines recommend nebulized β-agonists, IV (intravenous) drip corticosteroids, as well as IV drip aminophylline for acute asthma treatment. However, current treatment for acute asthma provides inadequate benefit for some patients. We evaluated the efficacy and safety of IV montelukast added to standard therapy in Japanese patients with acute asthma exacerbations.This multicenter, randomized, double-blind, parallel-group study compared IV montelukast 7 mg, 14 mg, and placebo in Japanese patients with acute asthma exacerbations (N = 242). Fifteen- to sixty-five-year-old patients with acute asthma were treated with standard care during a screening period that lasted ≤60 minutes. Patients with FEV(1) (forced expiratory volume in 1 second) ≤70 predicted were randomly allocated to one of three treatment groups. The primary end point was the time-weighted average change in FEV(1) from baseline over 60 minutes [ΔFEV(1) (0-60 minutes)] after study drug administration. Secondary end points included the time-weighted average change in FEV(1) over 20, 40, and 120 minutes [ΔFEV(1) (0-T min)].IV montelukast 7 mg was significantly more effective than placebo for the time-weighted average ΔFEV(1) (0-60 minutes) [least squares (LS) mean 0.09 L vs. 0.01 L; p.05]. IV montelukast 14 mg was also more effective than placebo (LS mean 0.17 L; p.001). Similar improvements in time-weighted average [ΔFEV(1) (0-T min)] were seen at all time points (all p.05). Both doses of IV montelukast demonstrated a significant increase in average ΔFEV(1) compared with placebo within 10 minutes of administration (p.001 to p.01). The tolerability of IV montelukast was similar to that of placebo.IV montelukast was significantly more effective than placebo in the improvement of ΔFEV(1) in Japanese patients, suggesting its role as an adjunctive therapy to existing guideline recommendations. |
| Databáze: | OpenAIRE |
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