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document
Salmeterol versus slow-release theophylline combined with ketotifen in nocturnal asthma : a multicentre trial . French Multicentre Study Group . We wished to assess the efficacy of inhaled salmeterol ( SML ; 50 micrograms b.i.d . ) compared to a combination of slow-release theophylline and ketotifen p.o . ( TK ; T 300 mg+K 1 mg b.i.d . ) for the treatment of nocturnal asthma . Ninety six patients with nocturnal asthma , ( forced expiratory volume in one second ( FEV1 ) 60-90 % of predicted value , reversibility > or = 15 % , at least two nocturnal awakenings per week ) were eligible for a multicentre , double-blind , double-dummy cross-over study ( 14-day run-in , two successive 28-day treatment periods ) . Efficacy was assessed as success/failure , success being defined as the complete disappearance of nocturnal symptoms/awakening during the last week of each treatment period . There was a statistically significant difference between SML and TK for this criterion : 46 % and 39 % success with SML during periods I ( first 28-day period ) and II ( following the cross-over ) , compared to only 15 % and 26 % with TK , respectively ( p < 0.01 ) . SML was also significantly better for the other criteria ( lung function , rescue salbutamol intake during day and night ) . Side-effects were five times less frequent in SML-treated patients ( p < 0.004 ) . Efficacy and tolerance of SML were obviously far better than those of TK in patients with nocturnal asthma .
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Intervention_Pharmacological
Salmeterol
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Intervention_Pharmacological
theophylline
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Intervention_Pharmacological
ketotifen
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Intervention_Pharmacological
salmeterol
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Intervention_Pharmacological
theophylline and ketotifen
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Outcome_Other
efficacy
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Outcome_Other
Efficacy
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Outcome_Other
success/failure , success
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Outcome_Other
statistically significant difference
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Outcome_Physical
lung function , rescue salbutamol intake during day and night
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Outcome_Adverse-effects
Side-effects
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Outcome_Other
Efficacy and tolerance
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Participant_Condition
nocturnal asthma :