ISSN:
1398-9995
Source:
Blackwell Publishing Journal Backfiles 1879-2005
Topics:
Medicine
Notes:
Brambilla C, Chastang C, Georges D, Bertin L. Salmeterol compared with slow-release terbutaline in nocturnal asthma. A multicenter, randomized, double-blind, double-dummy, sequential clinical trial.The aim of the multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial with a 2-week treatment period was to compare the efficacy and safety of salmeterol (50 ug twice daily) with slow-release (SR) terbutaline (5 μg orally, twice daily) in nocturnal asthma. A total of 159 asthmatic adults (FEV, 50-90% of predicted value; sex ratio: 0.87) with at least two nocturnal awakenings during a 7-d run-in period was included in the study. Patients were centrally randomized with a national computer network (Minitel®). The main variable (number of awakening-free nights during the last week of treatment) was analyzed according to a sequential method with the one-sided triangular test. The number of awakening-free nights (± SD) was significantly higher in the salmeterol group: 5.3 ± 2.4 vs 4.6 ± 2.3 (P= 0.006). Salmeterol was significantly more effective than SR-terbutaline in the following factors: number of patients without any awakening during the last week of treatment (50%vs 27%, P = 0.003), mean morning PEF (351 ± 1091/min-1vs 332 + 105 I/min-1, P= 0.04), PEF diurnal variation 6 ± 10%vs 11 ± 12%, P= 0.01), overall assessment of efficacy by the patient and the investigator (P= 0.001 and 0.005, respectively), and daily rescue salbutamol intakes (P=0.004). In the salmeterol group, significantly fewer patients reported adverse events (16%vs 29%, P= 0.04). This study confirms that salmeterol, 50 μg twice daily, is particularly useful in controlling nocturnal symptoms of asthma: as compared with the control group, twice as many salmeterol-treated patients were totally free of nocturnal symptoms after 2 weeks of treatment.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1111/j.1398-9995.1994.tb00834.x
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