title: A comparison of two long-acting beta-agonists, oral bambuterol and inhaled salmeterol, in the treatment of moderate to severe asthmatic patients with nocturnal symptoms. The French Bambuterol Study Group.
abstract: This multicentre study was set up to compare the efficacies of two long-acting beta 2-agonists, oral bambuterol (20 mg nocte) and inhaled salmeterol (50 micrograms b.i.d.), for the treatment of moderate to severe asthmatics who were considered to be on optimal steroid/bronchodilator therapy, but continued to have troublesome nocturnal symptoms. The study was of double-blind, parallel-group design and comprised a 2-week run-in on previous maintenance therapy followed by a 6-week study treatment period. There were 117 randomized asthmatic patients aged 20-70 years (65 women and 52 men with a mean age of 45 and predicted FEV1 of 64%), who had been taking 800-2000 micrograms inhaled steroid and/or up to 20 mg oral steroid per day for at least 4 weeks. They were asked to complete daily diary cards, recording morning and evening PEF, daily symptoms, nocturnal awakenings, rescue medication and subjective tremor. There was a significant increase in both morning and evening PEF respectively, on bambuterol (28 l min-1, 20 l min-1, P < 0.05) and salmeterol (29 l min-1, P < 0.001; 23 l min-1, P < 0.01) when compared with run-in. The mean percentage fall in overnight PEF was reduced by 8.3% (P < 0.001) on bambuterol and by 6.8% (P < 0.001) on salmeterol. Nocturnal awakenings and daytime symptoms due to asthma were significantly lowered by both treatments, as was the consumption of rescue bronchodilator. Tremor scores were very low during both run-in and study treatments. No significant treatment difference between bambuterol and salmeterol was detected for any of the above variables. Once-daily oral bambuterol provides a highly effective alternative to twice-daily inhaled salmeterol for relief of nocturnal symptoms in patients with moderate to severe asthma.
authors.affiliation: Centre Hospitalier Universitaire Calmette, Lille, France.
authors.forename: B
authors.initials: B
authors.lastname: Wallaert
authors.forename: P
authors.initials: P
authors.lastname: Brun
authors.forename: J
authors.initials: J
authors.lastname: Ostinelli
authors.forename: D
authors.initials: D
authors.lastname: Murciano
authors.forename: F
authors.initials: F
authors.lastname: Champel
authors.forename: B
authors.initials: B
authors.lastname: Blaive
authors.forename: F
authors.initials: F
authors.lastname: Montané
authors.forename: P
authors.initials: P
authors.lastname: Godard
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068299:Salmeterol Xinafoate; D018709:Statistics, Nonparametric; D013726:Terbutaline / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000318:Adrenergic beta-Agonists; D003692:Delayed-Action Preparations; D000068299:Salmeterol Xinafoate; D013726:Terbutaline; D000420:Albuterol; C047766:bambuterol