human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The aim of the study was to investigate the effect of addition of montelukast to inhaled fluticasone propionate ( FP ) therapy , compared with FP therapy alone ( 100 microg twice a day ) on airway immunopathology in individuals with mild asthma . Twenty-eight subjects received FP ( 100 microg twice a day ) or FP ( 100 microg twice a day ) plus montelukast ( 10 mg at night ) for 8 weeks and were then crossed over to the alternate treatment for a further 8 weeks . Physiological measurements and bronchial biopsies were obtained at + /- 2 days before treatment and + /- 2 days at the end of each treatment period . A two-period crossover analysis was performed and the mean and SE were calculated . There was no significant difference in percent predicted FEV1 ( p = 0.51 ) or PC20 mg/ml ( p = 0.81 ) between the two treatment regimes after 8 weeks of therapy . There was no difference in the efficacy of either treatment in decreasing T cell ( p = 0.97 ) , CD45RO+ ( p = 0.37 ) , mast cell ( p = 0.37 ) , or activated eosinophils ( p = 0.55 ) numbers in bronchial biopsies . There was no significant difference in the percentage area stained for IFN-gamma ( p = 0.76 ) or interleukin-4 ( p = 0.61 ) between treatments . Reduction of inflammatory cell numbers in the bronchial mucosa achieved with FP plus montelukast was not significantly different from the reduction observed with FP alone in individuals with mild asthma STUDY OBJECTIVE Evidence for the anti-inflammatory activity of leukotriene receptor antagonists in humans is somewhat limited . There are also no data comparing the anti-inflammatory effects of leukotriene receptor antagonists with those of inhaled corticosteroids . This study was design ed to assess the clinical efficacy and anti-inflammatory effects of leukotriene receptor antagonist plus low-dose inhaled corticosteroids compared to those of a high-dose inhaled corticosteroid in patients with mild-to-moderate asthma . METHODS Forty-nine patients with newly diagnosed asthma were recruited . They were r and omly assigned to groups that received , for a 6-week period , either ( 1 ) budesonide , 600 microg bid ( 1,200 microg/d ) or ( 2 ) budesonide , 200 microg ( 400 microg/d ) , and zafirlukast , 20 mg bid . The variables of asthma control were recorded daily . Sputum induction and methacholine provocation tests were performed . RESULTS The results indicated that the administration of a low-dose inhaled corticosteroid plus zafirlukast was as effective as that of a high-dose inhaled corticosteroid regarding clinical improvement and anti-inflammatory effects ( ie , eosinophil percentage , and eosinophilic cationic protein [ ECP ] and cysteinyl leukotriene C4 levels in induced sputum ) . Nineteen ( group 1 , 8 patients ; group 2 , 11 patients ) of 49 patients ( 38.8 % ) had returned to normal airway responsiveness after treatment . Among these patients , 16 patients ( 84.2 % ) had normal ECP levels and 10 patients ( 52.6 % ) had normal percentages of eosinophils . ECP level , but not the eosinophil percentage , was significantly associated with symptom scores . The peak expiratory flow rate ( PEFR ) showed a significant correlation with the provocative concentration of methacholine causing a 20 % fall in FEV1 ( PC20 ) instead of with symptom scores . CONCLUSIONS The addition of a leukotriene modifier to treatment with low-dose inhaled corticosteroids is equivalent to treatment with high-dose inhaled corticosteroids in patients with newly diagnosed mild-to-moderate asthma . In addition to symptoms and PEFR , the monitoring of ECP and PC20 may be of great value in achieving optimal control of asthma OBJECTIVE Many asthmatic patients are unable to quit cigarettes ; therefore information is needed on treatment options for smokers . This study evaluates 10 mg/d montelukast and 250 μg of fluticasone propionate twice daily , each compared with placebo , in patients with self-reported active smoking ( unable to quit ) and asthma . METHODS Patients ( ages 18 - 55 years , with asthma [ ≥1 year ] , FEV1 of 60 % to 90 % of predicted value , airway reversibility [ ≥12 % ] , and self-reported active smoking [ ≥0.5 to ≤2 packs per day ] ) were r and omized ( after a 3-week , single-blind , placebo , run-in period ) to 1 of 3 parallel , 6-month , double-blind treatment arms . The primary efficacy end point was the percentage of days with asthma control during treatment . Adverse experiences ( AEs ) were also evaluated . RESULTS There were 347 , 336 , and 336 patients r and omized to montelukast , fluticasone , and placebo , respectively . The mean percentage of days with asthma control over 6 months of treatment was 45 % ( montelukast , P < .05 vs placebo ) , 49 % ( fluticasone , P < .001 vs placebo ) , and 39 % ( placebo ) ; the difference between montelukast and fluticasone was not significant ( P = .14 ) . Patients with a smoking history of ≤11 pack years ( the median value ) tended to show more benefit with fluticasone , whereas those with a smoking history of > 11 pack years tended to show more benefit with montelukast  . AEs occurred in similar proportions among treatment groups . CONCLUSIONS In a population of asthmatic patients actively smoking cigarettes , both 10 mg/d montelukast and 250 μg of fluticasone propionate twice daily significantly increased the mean percentage of days with asthma control compared with placebo Background : The motive behind conducting this study was to determine if better control of asthma can be achieved by adding a second controller medication and to assess its use to reduce the dose of inhaled steroids . Objectives : The study aim ed to determine whether either oral sustained-release theophylline or montelukast added to inhaled steroids  improved clinical symptoms and pulmonary function test parameters when compared to high-dose steroids alone . Methods : Ninety patients with incompletely controlled asthma were allocated , in a r and omised , double-blind fashion , to one of three treatment groups : group A : double dose of inhaled budesonide ( 400 µg b.i.d . ) , group B : 400 mg oral sustained-release theophylline plus budesonide ( 200 µg b.i.d . ) and group C : 10 mg montelukast plus budesonide ( 200 µg b.i.d . ) . The primary endpoints were forced expiratory volume in 1 s ( FEV1 ) and mean morning peak expiratory flow rate ( PEFR ) . Results : All three groups had improved FEV1 and PEFR at 8 weeks ( p < 0.001 ) . Group C increased their PEFR by 18.7 l/min ( 95 % confidence interval , CI , 12.4–25.1 ) more than group A and by 19.8 l/min ( 95 % CI 13.4–26.1 ) more than group B ( both p = 0.001 ) . Similarly , group C had a 114 ml ( 95 % CI 45–183 ml ) greater improvement in FEV1 than group A and a 95 ml ( 95 % CI 26–164 ml ) greater improvement than group B ( both p = 0.01 ) . Conclusions : Addition of montelukast to budesonide is safe and results in greater improvement in pulmonary function test parameters  than high-dose budesonide treatment or addition of theophylline BACKGROUND Most r and omized trials of treatment for asthma study highly selected patients under idealized conditions . METHODS We conducted two parallel , multicenter , pragmatic trials to evaluate the real-world effectiveness of a leukotriene-receptor antagonist ( LTRA ) as compared with either an inhaled glucocorticoid for first-line asthma-controller therapy or a long-acting beta(2)-agonist ( LABA ) as add-on therapy in patients already receiving inhaled glucocorticoid therapy . Eligible primary care patients 12 to 80 years of age had impaired asthma-related quality of life ( Mini Asthma Quality of Life Question naire [ MiniAQLQ ] score ≤6 ) or inadequate asthma control ( Asthma Control Question naire [ ACQ ] score ≥1 ) . We r and omly assigned patients to 2 years of open-label therapy , under the care of their usual physician , with LTRA ( 148 patients ) or an inhaled glucocorticoid ( 158 patients ) in the first-line controller therapy trial and LTRA ( 170 patients ) or LABA ( 182 patients ) added to an inhaled glucocorticoid in the add-on therapy trial . RESULTS Mean MiniAQLQ scores increased by 0.8 to 1.0 point over a period of 2 years in both trials . At 2 months , differences in the MiniAQLQ scores between the two treatment groups met our definition of equivalence ( 95 % confidence interval [ CI ] for an adjusted mean difference , -0.3 to 0.3 ) . At 2 years , mean MiniAQLQ scores approached equivalence , with an adjusted mean difference between treatment groups of -0.11 ( 95 % CI , -0.35 to 0.13 ) in the first-line controller therapy trial and of -0.11 ( 95 % CI , -0.32 to 0.11 ) in the add-on therapy trial . Exacerbation rates and ACQ scores did not differ significantly between the two groups . CONCLUSIONS Study results at 2 months suggest that LTRA was equivalent to an inhaled glucocorticoid as first-line controller therapy and to LABA as add-on therapy for diverse primary care patients . Equivalence was not proved at 2 years . The interpretation of results of pragmatic research may be limited by the crossover between treatment groups and lack of a placebo group . ( Funded by the National Coordinating Centre for Health Technology Assessment U.K. and others ; Controlled Clinical Trials number , IS RCT N99132811 . ) The present study aim ed at comparing the effects of a dose reduction of inhaled corticosteroids on lung function , indirect measures of airway inflammation and clinical scores during treatment with a leucotriene receptor antagonist . In 50 patients ( mean forced expiratory volume in one second ( FEV1 ) 94 % predicted ) , steroid doses ( 800 µg beclomethasone dipropionate ) were first reduced to 50 % and then to 25 % , for 6 weeks each . One group received a placebo and the other group received montelukast ( 10 mg ) . The first reduction did not cause significant effects . During the second , FEV1 and peak expiratory flow decreased in both groups ( p<0.001 ) . Daytime symptoms were not altered with placebo but were reduced by montelukast ( p<0.05 ) . Night-time symptoms were slightly elevated with placebo ( p<0.05 ) but not montelukast , as well as the use of supplemental salbutamol  . Changes in provocative concentration of methacholine causing a 20 % fall in FEV1 ( PC20 ) , sputum eosinophils and exhaled nitric oxide were mostly nonsignificant for both placebo and montelukast . These data demonstrate that a 75 % reduction in the dose of steroid given to patients with asthma led to a deterioration in lung function not prevented by montelukast , whereas changes in clinical state seemed to favour montelukast treatment . It therefore appears that potential effects of montelukast , in the presence of low-dose steroids , could not be attributed to single indices of lung function or airway inflammation STUDY OBJECTIVE In acute exacerbations of asthma in children , corticosteroids reduce relapses , subsequent hospital admission , and the need for ß2-agonist bronchodilators . Prednisolone is the most commonly used corticosteroid , but prolonged treatment course , vomiting , and a bitter taste may reduce patient compliance . Dexamethasone has a longer half-life and has been used safely in other acute pediatric conditions . We examine whether a single dose of oral dexamethasone is noninferior to prednisolone in the emergency department ( ED ) treatment of asthma exacerbations in children , as measured by the Pediatric Respiratory Assessment Measure ( PRAM ) at day 4 . METHODS We conducted a r and omized , open-label , noninferiority trial comparing oral dexamethasone ( single dose of 0.3 mg/kg ) with prednisolone ( 1 mg/kg per day for 3 days ) in patients aged 2 to 16 years and with a known diagnosis of asthma or at least 1 previous episode of ß2-agonist-responsive wheeze who presented to a tertiary pediatric ED . The primary outcome measure was the mean PRAM score ( range of 0 to 12 points 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The aim of the study was to investigate the effect of addition of montelukast to inhaled fluticasone propionate ( FP ) therapy , compared with FP therapy alone ( 100 microg twice a day ) on airway immunopathology in individuals with mild asthma . Twenty-eight subjects received FP ( 100 microg twice a day ) or FP ( 100 microg twice a day ) plus montelukast ( 10 mg at night ) for 8 weeks and were then crossed over to the alternate treatment for a further 8 weeks . Physiological measurements and bronchial biopsies were obtained at + /- 2 days before treatment and + /- 2 days at the end of each treatment period . A two-period crossover analysis was performed and the mean and SE were calculated . There was no significant difference in percent predicted FEV1 ( p = 0.51 ) or PC20 mg/ml ( p = 0.81 ) between the two treatment regimes after 8 weeks of therapy . There was no difference in the efficacy of either treatment in decreasing T cell ( p = 0.97 ) , CD45RO+ ( p = 0.37 ) , mast cell ( p = 0.37 ) , or activated eosinophils ( p = 0.55 ) numbers in bronchial biopsies . There was no significant difference in the percentage area stained for IFN-gamma ( p = 0.76 ) or interleukin-4 ( p = 0.61 ) between treatments . Reduction of inflammatory cell numbers in the bronchial mucosa achieved with FP plus montelukast was not significantly different from the reduction observed with FP alone in individuals with mild asthma STUDY OBJECTIVE Evidence for the anti-inflammatory activity of leukotriene receptor antagonists in humans is somewhat limited . There are also no data comparing the anti-inflammatory effects of leukotriene receptor antagonists with those of inhaled corticosteroids . This study was design ed to assess the clinical efficacy and anti-inflammatory effects of leukotriene receptor antagonist plus low-dose inhaled corticosteroids compared to those of a high-dose inhaled corticosteroid in patients with mild-to-moderate asthma . METHODS Forty-nine patients with newly diagnosed asthma were recruited . They were r and omly assigned to groups that received , for a 6-week period , either ( 1 ) budesonide , 600 microg bid ( 1,200 microg/d ) or ( 2 ) budesonide , 200 microg ( 400 microg/d ) , and zafirlukast , 20 mg bid . The variables of asthma control were recorded daily . Sputum induction and methacholine provocation tests were performed . RESULTS The results indicated that the administration of a low-dose inhaled corticosteroid plus zafirlukast was as effective as that of a high-dose inhaled corticosteroid regarding clinical improvement and anti-inflammatory effects ( ie , eosinophil percentage , and eosinophilic cationic protein [ ECP ] and cysteinyl leukotriene C4 levels in induced sputum ) . Nineteen ( group 1 , 8 patients ; group 2 , 11 patients ) of 49 patients ( 38.8 % ) had returned to normal airway responsiveness after treatment . Among these patients , 16 patients ( 84.2 % ) had normal ECP levels and 10 patients ( 52.6 % ) had normal percentages of eosinophils . ECP level , but not the eosinophil percentage , was significantly associated with symptom scores . The peak expiratory flow rate ( PEFR ) showed a significant correlation with the provocative concentration of methacholine causing a 20 % fall in FEV1 ( PC20 ) instead of with symptom scores . CONCLUSIONS The addition of a leukotriene modifier to treatment with low-dose inhaled corticosteroids is equivalent to treatment with high-dose inhaled corticosteroids in patients with newly diagnosed mild-to-moderate asthma . In addition to symptoms and PEFR , the monitoring of ECP and PC20 may be of great value in achieving optimal control of asthma OBJECTIVE Many asthmatic patients are unable to quit cigarettes ; therefore information is needed on treatment options for smokers . This study evaluates 10 mg/d montelukast and 250 μg of fluticasone propionate twice daily , each compared with placebo , in patients with self-reported active smoking ( unable to quit ) and asthma . METHODS Patients ( ages 18 - 55 years , with asthma [ ≥1 year ] , FEV1 of 60 % to 90 % of predicted value , airway reversibility [ ≥12 % ] , and self-reported active smoking [ ≥0.5 to ≤2 packs per day ] ) were r and omized ( after a 3-week , single-blind , placebo , run-in period ) to 1 of 3 parallel , 6-month , double-blind treatment arms . The primary efficacy end point was the percentage of days with asthma control during treatment . Adverse experiences ( AEs ) were also evaluated . RESULTS There were 347 , 336 , and 336 patients r and omized to montelukast , fluticasone , and placebo , respectively . The mean percentage of days with asthma control over 6 months of treatment was 45 % ( montelukast , P < .05 vs placebo ) , 49 % ( fluticasone , P < .001 vs placebo ) , and 39 % ( placebo ) ; the difference between montelukast and fluticasone was not significant ( P = .14 ) . Patients with a smoking history of ≤11 pack years ( the median value ) tended to show more benefit with fluticasone , whereas those with a smoking history of > 11 pack years tended to show more benefit with montelukast  . AEs occurred in similar proportions among treatment groups . CONCLUSIONS In a population of asthmatic patients actively smoking cigarettes , both 10 mg/d montelukast and 250 μg of fluticasone propionate twice daily significantly increased the mean percentage of days with asthma control compared with placebo Background : The motive behind conducting this study was to determine if better control of asthma can be achieved by adding a second controller medication and to assess its use to reduce the dose of inhaled steroids . Objectives : The study aim ed to determine whether either oral sustained-release theophylline or montelukast added to inhaled steroids  improved clinical symptoms and pulmonary function test parameters when compared to high-dose steroids alone . Methods : Ninety patients with incompletely controlled asthma were allocated , in a r and omised , double-blind fashion , to one of three treatment groups : group A : double dose of inhaled budesonide ( 400 µg b.i.d . ) , group B : 400 mg oral sustained-release theophylline plus budesonide ( 200 µg b.i.d . ) and group C : 10 mg montelukast plus budesonide ( 200 µg b.i.d . ) . The primary endpoints were forced expiratory volume in 1 s ( FEV1 ) and mean morning peak expiratory flow rate ( PEFR ) . Results : All three groups had improved FEV1 and PEFR at 8 weeks ( p < 0.001 ) . Group C increased their PEFR by 18.7 l/min ( 95 % confidence interval , CI , 12.4–25.1 ) more than group A and by 19.8 l/min ( 95 % CI 13.4–26.1 ) more than group B ( both p = 0.001 ) . Similarly , group C had a 114 ml ( 95 % CI 45–183 ml ) greater improvement in FEV1 than group A and a 95 ml ( 95 % CI 26–164 ml ) greater improvement than group B ( both p = 0.01 ) . Conclusions : Addition of montelukast to budesonide is safe and results in greater improvement in pulmonary function test parameters  than high-dose budesonide treatment or addition of theophylline BACKGROUND Most r and omized trials of treatment for asthma study highly selected patients under idealized conditions . METHODS We conducted two parallel , multicenter , pragmatic trials to evaluate the real-world effectiveness of a leukotriene-receptor antagonist ( LTRA ) as compared with either an inhaled glucocorticoid for first-line asthma-controller therapy or a long-acting beta(2)-agonist ( LABA ) as add-on therapy in patients already receiving inhaled glucocorticoid therapy . Eligible primary care patients 12 to 80 years of age had impaired asthma-related quality of life ( Mini Asthma Quality of Life Question naire [ MiniAQLQ ] score ≤6 ) or inadequate asthma control ( Asthma Control Question naire [ ACQ ] score ≥1 ) . We r and omly assigned patients to 2 years of open-label therapy , under the care of their usual physician , with LTRA ( 148 patients ) or an inhaled glucocorticoid ( 158 patients ) in the first-line controller therapy trial and LTRA ( 170 patients ) or LABA ( 182 patients ) added to an inhaled glucocorticoid in the add-on therapy trial . RESULTS Mean MiniAQLQ scores increased by 0.8 to 1.0 point over a period of 2 years in both trials . At 2 months , differences in the MiniAQLQ scores between the two treatment groups met our definition of equivalence ( 95 % confidence interval [ CI ] for an adjusted mean difference , -0.3 to 0.3 ) . At 2 years , mean MiniAQLQ scores approached equivalence , with an adjusted mean difference between treatment groups of -0.11 ( 95 % CI , -0.35 to 0.13 ) in the first-line controller therapy trial and of -0.11 ( 95 % CI , -0.32 to 0.11 ) in the add-on therapy trial . Exacerbation rates and ACQ scores did not differ significantly between the two groups . CONCLUSIONS Study results at 2 months suggest that LTRA was equivalent to an inhaled glucocorticoid as first-line controller therapy and to LABA as add-on therapy for diverse primary care patients . Equivalence was not proved at 2 years . The interpretation of results of pragmatic research may be limited by the crossover between treatment groups and lack of a placebo group . ( Funded by the National Coordinating Centre for Health Technology Assessment U.K. and others ; Controlled Clinical Trials number , IS RCT N99132811 . ) The present study aim ed at comparing the effects of a dose reduction of inhaled corticosteroids on lung function , indirect measures of airway inflammation and clinical scores during treatment with a leucotriene receptor antagonist . In 50 patients ( mean forced expiratory volume in one second ( FEV1 ) 94 % predicted ) , steroid doses ( 800 µg beclomethasone dipropionate ) were first reduced to 50 % and then to 25 % , for 6 weeks each . One group received a placebo and the other group received montelukast ( 10 mg ) . The first reduction did not cause significant effects . During the second , FEV1 and peak expiratory flow decreased in both groups ( p<0.001 ) . Daytime symptoms were not altered with placebo but were reduced by montelukast ( p<0.05 ) . Night-time symptoms were slightly elevated with placebo ( p<0.05 ) but not montelukast , as well as the use of supplemental salbutamol  . Changes in provocative concentration of methacholine causing a 20 % fall in FEV1 ( PC20 ) , sputum eosinophils and exhaled nitric oxide were mostly nonsignificant for both placebo and montelukast . These data demonstrate that a 75 % reduction in the dose of steroid given to patients with asthma led to a deterioration in lung function not prevented by montelukast , whereas changes in clinical state seemed to favour montelukast treatment . It therefore appears that potential effects of montelukast , in the presence of low-dose steroids , could not be attributed to single indices of lung function or airway inflammation STUDY OBJECTIVE In acute exacerbations of asthma in children , corticosteroids reduce relapses , subsequent hospital admission , and the need for ß2-agonist bronchodilators . Prednisolone is the most commonly used corticosteroid , but prolonged treatment course , vomiting , and a bitter taste may reduce patient compliance . Dexamethasone has a longer half-life and has been used safely in other acute pediatric conditions . We examine whether a single dose of oral dexamethasone is noninferior to prednisolone in the emergency department ( ED ) treatment of asthma exacerbations in children , as measured by the Pediatric Respiratory Assessment Measure ( PRAM ) at day 4 . METHODS We conducted a r and omized , open-label , noninferiority trial comparing oral dexamethasone ( single dose of 0.3 mg/kg ) with prednisolone ( 1 mg/kg per day for 3 days ) in patients aged 2 to 16 years and with a known diagnosis of asthma or at least 1 previous episode of ß2-agonist-responsive wheeze who presented to a tertiary pediatric ED . The primary outcome measure was the mean PRAM score ( range of 0 to 12 points 
    Output:
    