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Salmeterol compared with slow‐release terbutaline in nocturnal asthma A multicenter, randomized, double‐blind, double‐dummy, sequential clinical trial
Author(s) -
Brambilla C.,
Chastang C.,
Georges D.,
Bertin L.,
Desfougeres Dr JeanLuc
Publication year - 1994
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/j.1398-9995.1994.tb00834.x
Subject(s) - salmeterol , salbutamol , terbutaline , medicine , randomized controlled trial , morning , asthma , anesthesia , double blind , nocturnal , randomization , bronchodilator , placebo , alternative medicine , pathology
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 ‐1 vs 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.