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: Pranlukast ( 8‐[p‐(4‐phenylbutyloxy ) benzol ] amino‐2‐[tetrazol‐5‐yl]‐4‐oxo‐4H‐1‐benzopyran hemihydrate ) , a selective cysteinyl leukotriene receptor antagonist , has been reported to exhibit not only antileukotrine activity but also pharmacological activity including antieosinophilic effects BACKGROUND It has been reported that pranlukast reduces the antigen induced immediate and late phase asthmatic responses , airway hyperreactivity to acetylcholine , and pulmonary eosinophil accumulation in guinea pigs . A study was undertaken to test the hypothesis that pranlukast may reduce the number of inflammatory cells in the bronchial mucosa of patients with asthma . METHODS A double blind , placebo controlled study was performed in 17 mild to moderate asthmatic subjects to examine changes in inflammatory cell infiltration in response to pranlukast ( 225 mg orally twice per day for four weeks ) . Comparisons of the mean daily β2 agonist use , symptom score , FEV1 percentage predicted , and airway methacholine responsiveness were made before and after treatment . Using fibreoptic bronchoscopy , bronchial biopsy specimens were obtained before and after treatment with either pranlukast ( n = 10 ) or placebo ( n = 7 ) . Immunohistology was performed using monoclonal antibodies for CD3 , CD4 , CD8 , CD68 , NP57 , AA1 , EG1 , EG2 , γGTP and CD19 . RESULTS When the pranlukast and placebo treated groups were compared there were decreases in β2agonist use , symptom score , and airway methacholine responsiveness  after pranlukast but no increase in FEV1 was seen . The clinical response in patients treated with pranlukast was accompanied by a reduction in CD3 ( median difference –37 , 95 % confidence interval ( CI ) –69 to –1 ; p<0.05 ) , CD4 ( median difference –28 , 95 % CI –49 to –8 ; p<0.01 ) , AA1 ( median difference –15 , 95 % CI –26 to 0 ; p<0.05 ) and EG2 positive cells ( 95 % CI –35 to 0 ; p<0.05 ) , but not in EG1 positive eosinophils , γGTP positive cells , and CD19 positive plasma cells . CONCLUSIONS These results support the view that pranlukast may act by inhibition of bronchial inflammation in patients with asthma Background Asthma affects mainly Venezuela ’s urban and poor majority . Exacerbations bring about a high dem and in health services , thus becoming a significant public health problem . In general , asthma control programs ( GINA ) with use of inhaled steroid medications have proven effective , although their implementation in real life remains cumbersome . Montelukast could be a useful and practical tool for these deprived socioeconomic sectors . Methods This real-life pilot study was conducted in a prospect i ve , double blinded , placebo-controlled manner with r and omized and parallel groups . Asthmatics that had never used leukotriene modifiers were recruited and followed-up every three months . The main outcome was the number of exacerbations meriting use of nebulized bronchodilators  administered by the health care system . Results Eighty-eight asthmatic patients were enrolled , between children and adults . Groups were comparable in : demographic data , previous use of other medications , ACT scores , pulmonary functions ( Wright Peak Flow meter ) , allergy status ( Skin Prick Test ) as well as adherence to the prescribed Montelukast treatment . By an intention to treat ( ITT ) , a total of 64 patients were included for analysis . For the three and six months time points the difference between placebo and Montelukast was found to be significant ( p < 0.03 and p < 0.04 , respectively ) . Such trends continued for the rest of the year , but without statistical significance , due to patient attrition . Conclusions This real-life pilot study shows that a simplified strategy with oral Montelukast was practical and effective in controlling exacerbations in an asthmatic population of a vulnerable community from Caracas . Such an approach reinforces the role of primary care in asthma treatment 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 Leukotrienes , especially LTC4 , are important inflammatory mediators in allergic and nonallergic inflammation of the entire airways . Of particular interest are numerous theories regarding the pathogenesis of aspirin intolerance with subsequent hyperproduction of leukotrienes and inhibition of cyclooxygenase . OBJECTIVE To examine the influence of the cysteinyl-leukotriene receptor antagonist montelukast on clinical symptoms and inflammatory markers in nasal lavage fluid in patients with bronchial asthma and nasal polyps , and determine its dependency on aspirin sensitization . METHODS Twenty-four patients ( 7 women , 17 men ; median age , 55.5 years ) with nasal polyps and controlled asthma ( n=12 with aspirin intolerance ) were treated with 10 mg montelukast once daily for 6 weeks in a blinded , placebo-controlled fashion . The placebo phase was r and omly assigned 4 weeks before ( n=12 ) or after treatment ( n=12 ) . Symptom score , rhinoendoscopy , rhinomanometry , smears for eosinophils , and nasal lavages for the determination of different mediators were performed . RESULTS Compared to placebo , there were significant improvements in the nasal symptom score and airflow limitation as well as a reduction in the inflammatory mediators in nasal lavage fluid after treatment . Furthermore , reduced eosinophils in nasal smears and peripheral blood were observed 2 and 6 weeks after treatment . CONCLUSION Leukotriene 1 receptor blockade led to a significant decrease in eosinophil inflammation accompanied by a reduction in other mediators such as neurokinin A and substance P in the nasal lavage fluid of patients with nasal polyps and asthma , with or without aspirin intolerance SUMMARY Objective : The objective of this study was to evaluate montelukast 10 mg daily as treatment for allergic rhinitis in patients with symptomatic allergic rhinitis and active asthma during the allergy season . Methods : This was a multicenter study of 831 patients ( ages 15 years–85 years ) with seasonal allergen sensitivity , active symptoms of seasonal allergic rhinitis , and active asthma . Following a single-blind , placebo run-in period of 3 days–5 days , patients were r and omized to oral montelukast 10 mg ( n = 415 ) or placebo ( n = 416 ) daily during the 2-week , double-blind , active-treatment period . Main outcome measures : The primary endpoint was Daily Rhinitis Symptoms score , average of Daytime Nasal Symptoms and Nighttime Symptoms , as self-rated by patients on a 0–3 scale on daily diaries . Results : Montelukast  reduced the Daily Rhinitis Symptoms score : difference between montelukast and placebo in mean change from baseline was –0.12 [ 95 % CI –0.18 , –0.06 ; p ≤ 0.001 ] . Similar improvements were seen in Daytime Nasal Symptoms ( –0.14 [ –0.21 , –0.07 ; p ≤ 0.001 ] ) and Nighttime Symptoms ( –0.10 [ –0.16,–0.04 ; p ≤ 0.001 ] ) . Improvements ( p < 0.05 ) were seen in Daytime Eye Symptoms and in the secondary endpoints of Global Evaluations of AR by Patient and by Physician , and Rhinoconjunctivitis Quality of Life . In exploratory analyses , improvement in rhinitis symptoms was numerically ( though not statistically ) larger in patients with greater levels of asthma at study start . Montelukast provided benefit in the Global Evaluations of Asthma by Patient and by Physician : mean differences were –0.24 [ –0.41 , –0.06 ; p = 0.008 ] and –0.17 [ –0.33,–0.01 ; p = 0.037 ] . Similarly , as-needed β-agonist use ( puffs/day ) was reduced with montelukast ( p ≤ 0.005 ) . Conclusion : Montelukast provides significant relief from symptoms of seasonal allergic rhinitis , while also conferring a benefit for asthma , in patients with both allergic rhinitis and asthma For patients with persistent asthma , the National Asthma Education and Prevention Program recommends the regular use of controller medications to provide long-term control , together with as-needed use of rescue medications ( 1 ) . Inhaled corticosteroids are currently the most commonly used controller medications ( 1 ) . Although inhalation into the airway has advantages in terms of both safety and efficacy , problems with compliance with inhaled agents may limit their real-world effectiveness , especially in elderly and pediatric patients ( 2 , 3 ) . Cysteinyl leukotrienes are important pro-inflammatory mediators of asthma ( 4 ) . Recent clinical studies of leukotriene receptor antagonists ( 5 - 7 ) and a 5-lipoxygenase inhibitor ( 8) have shown these agents to have clinical benefit in patients with chronic asthma , and treatment guidelines now consider these agents alternative , first-line controller medications ( 1 ) . Recent studies showed that montelukast , a potent and specific leukotriene receptor antagonist ( 9 ) , had efficacy in adult ( over a 12-week period ) and pediatric ( over an 8-week period ) patient with chronic asthma and had a tolerability profile similar to that of placebo ( 10 - 12 ) . To date , no comparisons of leukotriene receptor antagonists and inhaled corticosteroids have been published . Our placebo-controlled , parallel-group study , which was primarily design ed to compare the effect of montelukast with that of placebo in a phase III clinical development trial , also compared montelukast and inhaled beclomethasone in patients with chronic asthma who require the daily use of a controller medication . Methods Patients Healthy , nonsmoking , male and female patients 15 years of age and older were eligible to participate if they had had asthma for at least 1 year before the initial study evaluation . Each patient also had to have 1 ) an FEV1 between 50 % and 85 % of predicted value , 2 ) an increase of at least 15 % in absolute FEV1 after the use of inhaled -agonist on at least two of three visits during period 1 [ see below ] , 3 ) a daytime asthma symptom score of at least 64 [ of a possible 336 ] , and 4 ) average daily use of at least one puff of as-needed , short-acting , inhaled -agonist ( salbutamol )  . Patients were excluded from the study if they had used inhaled and oral corticosteroids , cromolyn , or nedocromil within 4 weeks before the initial evaluation ; had used long-acting -agonists , antimuscarinics , and newly instituted theophylline within 2 weeks before the initial evaluation ; or had used long-acting antihistamines ( for example , they could not have used astemizole within 3 months of the initial evaluation , and they could not have used terfenadine or loratadine within 2 weeks of the initial evaluation ) . Intermittent use of short-acting antihistamines was allowed , and immun 
    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: Pranlukast ( 8‐[p‐(4‐phenylbutyloxy ) benzol ] amino‐2‐[tetrazol‐5‐yl]‐4‐oxo‐4H‐1‐benzopyran hemihydrate ) , a selective cysteinyl leukotriene receptor antagonist , has been reported to exhibit not only antileukotrine activity but also pharmacological activity including antieosinophilic effects BACKGROUND It has been reported that pranlukast reduces the antigen induced immediate and late phase asthmatic responses , airway hyperreactivity to acetylcholine , and pulmonary eosinophil accumulation in guinea pigs . A study was undertaken to test the hypothesis that pranlukast may reduce the number of inflammatory cells in the bronchial mucosa of patients with asthma . METHODS A double blind , placebo controlled study was performed in 17 mild to moderate asthmatic subjects to examine changes in inflammatory cell infiltration in response to pranlukast ( 225 mg orally twice per day for four weeks ) . Comparisons of the mean daily β2 agonist use , symptom score , FEV1 percentage predicted , and airway methacholine responsiveness were made before and after treatment . Using fibreoptic bronchoscopy , bronchial biopsy specimens were obtained before and after treatment with either pranlukast ( n = 10 ) or placebo ( n = 7 ) . Immunohistology was performed using monoclonal antibodies for CD3 , CD4 , CD8 , CD68 , NP57 , AA1 , EG1 , EG2 , γGTP and CD19 . RESULTS When the pranlukast and placebo treated groups were compared there were decreases in β2agonist use , symptom score , and airway methacholine responsiveness  after pranlukast but no increase in FEV1 was seen . The clinical response in patients treated with pranlukast was accompanied by a reduction in CD3 ( median difference –37 , 95 % confidence interval ( CI ) –69 to –1 ; p<0.05 ) , CD4 ( median difference –28 , 95 % CI –49 to –8 ; p<0.01 ) , AA1 ( median difference –15 , 95 % CI –26 to 0 ; p<0.05 ) and EG2 positive cells ( 95 % CI –35 to 0 ; p<0.05 ) , but not in EG1 positive eosinophils , γGTP positive cells , and CD19 positive plasma cells . CONCLUSIONS These results support the view that pranlukast may act by inhibition of bronchial inflammation in patients with asthma Background Asthma affects mainly Venezuela ’s urban and poor majority . Exacerbations bring about a high dem and in health services , thus becoming a significant public health problem . In general , asthma control programs ( GINA ) with use of inhaled steroid medications have proven effective , although their implementation in real life remains cumbersome . Montelukast could be a useful and practical tool for these deprived socioeconomic sectors . Methods This real-life pilot study was conducted in a prospect i ve , double blinded , placebo-controlled manner with r and omized and parallel groups . Asthmatics that had never used leukotriene modifiers were recruited and followed-up every three months . The main outcome was the number of exacerbations meriting use of nebulized bronchodilators  administered by the health care system . Results Eighty-eight asthmatic patients were enrolled , between children and adults . Groups were comparable in : demographic data , previous use of other medications , ACT scores , pulmonary functions ( Wright Peak Flow meter ) , allergy status ( Skin Prick Test ) as well as adherence to the prescribed Montelukast treatment . By an intention to treat ( ITT ) , a total of 64 patients were included for analysis . For the three and six months time points the difference between placebo and Montelukast was found to be significant ( p < 0.03 and p < 0.04 , respectively ) . Such trends continued for the rest of the year , but without statistical significance , due to patient attrition . Conclusions This real-life pilot study shows that a simplified strategy with oral Montelukast was practical and effective in controlling exacerbations in an asthmatic population of a vulnerable community from Caracas . Such an approach reinforces the role of primary care in asthma treatment 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 Leukotrienes , especially LTC4 , are important inflammatory mediators in allergic and nonallergic inflammation of the entire airways . Of particular interest are numerous theories regarding the pathogenesis of aspirin intolerance with subsequent hyperproduction of leukotrienes and inhibition of cyclooxygenase . OBJECTIVE To examine the influence of the cysteinyl-leukotriene receptor antagonist montelukast on clinical symptoms and inflammatory markers in nasal lavage fluid in patients with bronchial asthma and nasal polyps , and determine its dependency on aspirin sensitization . METHODS Twenty-four patients ( 7 women , 17 men ; median age , 55.5 years ) with nasal polyps and controlled asthma ( n=12 with aspirin intolerance ) were treated with 10 mg montelukast once daily for 6 weeks in a blinded , placebo-controlled fashion . The placebo phase was r and omly assigned 4 weeks before ( n=12 ) or after treatment ( n=12 ) . Symptom score , rhinoendoscopy , rhinomanometry , smears for eosinophils , and nasal lavages for the determination of different mediators were performed . RESULTS Compared to placebo , there were significant improvements in the nasal symptom score and airflow limitation as well as a reduction in the inflammatory mediators in nasal lavage fluid after treatment . Furthermore , reduced eosinophils in nasal smears and peripheral blood were observed 2 and 6 weeks after treatment . CONCLUSION Leukotriene 1 receptor blockade led to a significant decrease in eosinophil inflammation accompanied by a reduction in other mediators such as neurokinin A and substance P in the nasal lavage fluid of patients with nasal polyps and asthma , with or without aspirin intolerance SUMMARY Objective : The objective of this study was to evaluate montelukast 10 mg daily as treatment for allergic rhinitis in patients with symptomatic allergic rhinitis and active asthma during the allergy season . Methods : This was a multicenter study of 831 patients ( ages 15 years–85 years ) with seasonal allergen sensitivity , active symptoms of seasonal allergic rhinitis , and active asthma . Following a single-blind , placebo run-in period of 3 days–5 days , patients were r and omized to oral montelukast 10 mg ( n = 415 ) or placebo ( n = 416 ) daily during the 2-week , double-blind , active-treatment period . Main outcome measures : The primary endpoint was Daily Rhinitis Symptoms score , average of Daytime Nasal Symptoms and Nighttime Symptoms , as self-rated by patients on a 0–3 scale on daily diaries . Results : Montelukast  reduced the Daily Rhinitis Symptoms score : difference between montelukast and placebo in mean change from baseline was –0.12 [ 95 % CI –0.18 , –0.06 ; p ≤ 0.001 ] . Similar improvements were seen in Daytime Nasal Symptoms ( –0.14 [ –0.21 , –0.07 ; p ≤ 0.001 ] ) and Nighttime Symptoms ( –0.10 [ –0.16,–0.04 ; p ≤ 0.001 ] ) . Improvements ( p < 0.05 ) were seen in Daytime Eye Symptoms and in the secondary endpoints of Global Evaluations of AR by Patient and by Physician , and Rhinoconjunctivitis Quality of Life . In exploratory analyses , improvement in rhinitis symptoms was numerically ( though not statistically ) larger in patients with greater levels of asthma at study start . Montelukast provided benefit in the Global Evaluations of Asthma by Patient and by Physician : mean differences were –0.24 [ –0.41 , –0.06 ; p = 0.008 ] and –0.17 [ –0.33,–0.01 ; p = 0.037 ] . Similarly , as-needed β-agonist use ( puffs/day ) was reduced with montelukast ( p ≤ 0.005 ) . Conclusion : Montelukast provides significant relief from symptoms of seasonal allergic rhinitis , while also conferring a benefit for asthma , in patients with both allergic rhinitis and asthma For patients with persistent asthma , the National Asthma Education and Prevention Program recommends the regular use of controller medications to provide long-term control , together with as-needed use of rescue medications ( 1 ) . Inhaled corticosteroids are currently the most commonly used controller medications ( 1 ) . Although inhalation into the airway has advantages in terms of both safety and efficacy , problems with compliance with inhaled agents may limit their real-world effectiveness , especially in elderly and pediatric patients ( 2 , 3 ) . Cysteinyl leukotrienes are important pro-inflammatory mediators of asthma ( 4 ) . Recent clinical studies of leukotriene receptor antagonists ( 5 - 7 ) and a 5-lipoxygenase inhibitor ( 8) have shown these agents to have clinical benefit in patients with chronic asthma , and treatment guidelines now consider these agents alternative , first-line controller medications ( 1 ) . Recent studies showed that montelukast , a potent and specific leukotriene receptor antagonist ( 9 ) , had efficacy in adult ( over a 12-week period ) and pediatric ( over an 8-week period ) patient with chronic asthma and had a tolerability profile similar to that of placebo ( 10 - 12 ) . To date , no comparisons of leukotriene receptor antagonists and inhaled corticosteroids have been published . Our placebo-controlled , parallel-group study , which was primarily design ed to compare the effect of montelukast with that of placebo in a phase III clinical development trial , also compared montelukast and inhaled beclomethasone in patients with chronic asthma who require the daily use of a controller medication . Methods Patients Healthy , nonsmoking , male and female patients 15 years of age and older were eligible to participate if they had had asthma for at least 1 year before the initial study evaluation . Each patient also had to have 1 ) an FEV1 between 50 % and 85 % of predicted value , 2 ) an increase of at least 15 % in absolute FEV1 after the use of inhaled -agonist on at least two of three visits during period 1 [ see below ] , 3 ) a daytime asthma symptom score of at least 64 [ of a possible 336 ] , and 4 ) average daily use of at least one puff of as-needed , short-acting , inhaled -agonist ( salbutamol )  . Patients were excluded from the study if they had used inhaled and oral corticosteroids , cromolyn , or nedocromil within 4 weeks before the initial evaluation ; had used long-acting -agonists , antimuscarinics , and newly instituted theophylline within 2 weeks before the initial evaluation ; or had used long-acting antihistamines ( for example , they could not have used astemizole within 3 months of the initial evaluation , and they could not have used terfenadine or loratadine within 2 weeks of the initial evaluation ) . Intermittent use of short-acting antihistamines was allowed , and immun 
    Output:
    