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document
A proof of concept study to evaluate putative benefits of montelukast in moderate persistent asthmatics . AIMS Whether chronic dosing with montelukast confers benefit in patients with moderate to severe asthma remains to be fully established . A proof of concept study was performed evaluating putative benefits with montelukast in moderate persistent asthmatics who were taken off inhaled corticosteroids ( ICS ) and switched to salmeterol . The latter was done to dissociate the effects of montelukast from ICS . METHODS Twenty moderate to severe persistent asthmatics completed a randomized double-blind crossover study . Subjects received montelukast 10 mg daily or placebo for 2 weeks each . This was preceded by a 2-week run-in when ICS were discontinued and salmeterol started , and used on a regular basis throughout the study . Measurements were made after run-in and after both randomized treatments . RESULTS There were no significant sequence effects for responses as to whether placebo or montelukast were given first or second . Methacholine PD20 values after run-in , first and second placebo were 63 micro g , 60 micro g and 64 micro g , respectively ( corresponding to 2 , 4 and 6 weeks of ICS washout , respectively ) . Lung function deteriorated pre vs post run-in , which was significant ( P < 0.05 ) for FEF25-75 % predicted . Montelukast conferred significant ( P < 0.05 ) improvements as change from post run-in compared with placebo in methacholine PD20 , FEV1 % predicted , FEF25-75 % predicted , diurnal peak expiratory flow , symptoms and salbutamol use . For the primary outcome of methacholine PD20 , this amounted to a 1.6-fold difference ( 95 % CI 1.1 , 2.5 ) . CONCLUSIONS In moderate persistent asthmatics switched from taking ICS to salmeterol alone , adding montelukast conferred significant benefits on all parameters of asthma control . Further studies are indicated to evaluate whether montelukast exhibits additive effects to ICS/long-acting beta2-adrenoceptor agonist combination inhalers upon clinically important outcomes .
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Intervention_Pharmacological
montelukast
13220
Intervention_Pharmacological
montelukast
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Intervention_Pharmacological
montelukast
13222
Intervention_Pharmacological
salmeterol
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Intervention_Pharmacological
montelukast
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Intervention_Pharmacological
montelukast 10 mg daily
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Intervention_Pharmacological
ICS
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Intervention_Pharmacological
salmeterol
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Intervention_Control
placebo
13228
Intervention_Pharmacological
montelukast
13229
Intervention_Control
placebo
13230
Intervention_Control
placebo
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Intervention_Pharmacological
salmeterol
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Intervention_Pharmacological
montelukast
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Intervention_Pharmacological
montelukast
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Outcome_Other
putative benefits
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Outcome_Other
sequence effects
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Outcome_Physical
Methacholine PD20 values
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Outcome_Physical
Lung function deteriorated
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Outcome_Physical
FEV1
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Outcome_Physical
FEF25-75
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Outcome_Physical
diurnal peak expiratory flow
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Outcome_Physical
symptoms
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Outcome_Other
salbutamol use
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Participant_Condition
moderate persistent asthmatics
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Participant_Condition
patients with moderate to severe asthma
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Participant_Sample-size
Twenty
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Participant_Condition
moderate to severe persistent asthmatics