Efficacy and safety of montelukast sodium on adult bronchial asthma in a multicentre comparative double-blind clinical study with pranlukast hydrate
T. Miyamoto, S. Makino, S. Kitamura, K. Ito, J. Kabe, K. Mano, S. Nakajima, M. Yamakido, H. Yasuhara (Tokyo, Japan)
Source: Annual Congress 2002 - Asthma and COPD: pharmacology
Session: Asthma and COPD: pharmacology
Session type: Thematic Poster Session
Number: 737
Disease area: Airway diseases
Abstract The effectiveness of montelukast sodium (Mont, 10mg q.d., n=189) in the treatment of adult bronchial asthma was examined in a four-week multicenter, randomised, double-blind, comparative study using pranlukast hydrate (Pran, 225mg b.i.d., n=179) as a comparator medication. The primary endpoint was a final global improvement rating, which is evaluated based on PEFR, concomitant medications, asthma symptoms, and patient impression. The rate of final global improvement (% of patients rated as having marked or moderate improvements) was 58.5% with Mont and 46.0% with Pran, indicating the noninferiority and superiority of Mont over Pran. The confidence intervals for differences in PEFR at waking and before dinner between the run-in period and weeks 2 and 4 did not include 0 in either treatment group. Patients receiving Mont showed significant improvement in FEV1 compared with those receiving Pran. Safety findings were similar in the two groups. The incidences of clinical adverse experiences were 11.0% (Mont) and 12.4% (Pran). The incidences of laboratory adverse experiences were 8.8% (Mont) and 4.1% (Pran). In conclusion, our results indicate that Mont is effective and well tolerated in the treatment of asthmatic patients.
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T. Miyamoto, S. Makino, S. Kitamura, K. Ito, J. Kabe, K. Mano, S. Nakajima, M. Yamakido, H. Yasuhara (Tokyo, Japan). Efficacy and safety of montelukast sodium on adult bronchial asthma in a multicentre comparative double-blind clinical study with pranlukast hydrate. Eur Respir J 2002; 20: Suppl. 38, 737
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