***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: OBJECTIVES This study investigated the efficacy and tolerability of a new asthma therapy combining fluticasone propionate and formoterol fumarate ( fluticasone/formoterol ) * , administered twice daily ( BID ) via a single aerosol inhaler , compared with fluticasone propionate ( fluticasone ) or formoterol fumarate ( formoterol ) administered alone , in patients with mild to moderate asthma . METHODS Patients aged ≥12 years were evenly r and omized to 12 weeks of treatment with fluticasone/formoterol ( 100/10 µg BID ) , fluticasone ( 100 µg BID ) , or formoterol ( 10 µg BID ) , in this multicenter , double-blind , parallel-group , study . The 2 co primary end points were : ( 1 ) change in forced expiratory volume in 1 second ( FEV(1 ) ) from morning predose at baseline to predose at week 12 for the comparison of the combination product with formoterol alone ; and ( 2 ) change in FEV(1 ) from morning predose at baseline to 2 hours postdose at week 12 for the comparison of the combination product with fluticasone alone . The secondary objective was to demonstrate the efficacy  of fluticasone/formoterol  using other pulmonary function tests and clinical end points . Tolerability was assessed based on adverse events , clinical laboratory tests and vital sign evaluations . RESULTS Statistically significant differences were demonstrated for the 2 co primary end points  . Fluticasone/formoterol combination therapy showed significantly greater improvements from baseline to end of study in the change in predose FEV(1 ) compared  with  formoterol ( least squares [ LS ] mean treatment difference , 0.118 L [ 95 % CI , 0.034 - 0.201 ; P = 0.006 ] ) and the change in predose compared with 2 hours postdose FEV(1 ) versus fluticasone ( LS mean treatment difference , 0.122 L [ 95 % CI , 0.040 - 0.204 ; P = 0.004 ] ) . Statistical analyses of the secondary efficacy endpoints revealed that evaluations of lung function , asthma exacerbations , asthma symptoms , rescue medication use and asthma control were supportive overall of the superior efficacy  of fluticasone/formoterol  combination therapy compared with its individual components ; were supportive overall of the efficacy of fluticasone/formoterol combination therapy compared with its individual components . Since the secondary endpoints were analyzed using the sequential gatekeeper approach , only the mean change from baseline to final week in morning peak expiratory flow rate between the combination-therapy and formoterol groups returned statistically significant results ( least squares mean difference , 20.05 [ 95 % CI , 7.631 - 32.472 ; P = 0.002 ] ) . The fluticasone/formoterol combination therapy had a good tolerability profile over the 12-week treatment period . CONCLUSIONS Fluticasone/formoterol had a good tolerability profile and showed statistically superior efficacy for the two co- primary endpoints compared to fluticasone or formoterol , in adolescents and adults with mild to moderate asthma . Clinical Trials.gov identifier : NCT00394199 Background The inhaled corticosteroid ( ICS ) fluticasone propionate ( fluticasone ) and the long-acting β2-agonist ( LABA ) formoterol fumarate ( formoterol ) are being made available as a combination product ( fluticasone/formoterol , flutiform ® ) in a single aerosol inhaler . This 12-week , open-label , r and omized , active-controlled , parallel-group , multicentre , phase 3 study compared the efficacy and safety of fluticasone/formoterol with the commercially available combination product fluticasone/salmeterol . Methods Patients aged ≥ 18 years ( N = 202 ) with mild-to-moderate – severe , persistent asthma for ≥ 6 months prior to screening were included in the study . After a screening phase ( 4–10 days ) , eligible patients were r and omized 1:1 to receive fluticasone/formoterol or fluticasone/salmeterol during the 12-week treatment period . The primary objective was to demonstrate non-inferiority  of fluticasone/formoterol versus fluticasone/salmeterol , measured by pre-dose forced expiratory volume in the first second ( FEV1 ) , at week 12 . Results Fluticasone/formoterol was comparable to fluticasone/salmeterol for the primary efficacy endpoint , mean pre-dose FEV1 at week 12 . The new combination was also comparable to fluticasone/salmeterol for change from baseline to week 12 in pre-dose FEV1 , change from pre-dose FEV1 at baseline to 2-hour post-dose FEV1 at week 12 and discontinuations due to lack of efficacy . Importantly , fluticasone/formoterol was superior to fluticasone/salmeterol in time to onset of action throughout the duration of the study . The two treatments demonstrated similar results for various other secondary efficacy parameters , including other lung function tests , patient-reported outcomes , rescue medication use , asthma exacerbations and Asthma Quality of Life Question naire scores . Fluticasone/formoterol was well tolerated and had a good safety profile that was similar to fluticasone/salmeterol . Conclusions The results of this study indicate that fluticasone/formoterol is as effective as fluticasone/salmeterol , and has a more rapid onset of action , reflecting the faster bronchodilatory effects of formoterol compared with those of salmeterol . If patients perceive the benefits of therapy with fluticasone/formoterol more rapidly than with fluticasone/salmeterol , this could have a positive impact on preference and adherence . Trial Registration Clinical Trials.gov : Objectives . The inhaled corticosteroid fluticasone propionate ( fluticasone ) and the long-acting β2 agonist formoterol fumarate ( formoterol ) have been combined in a single aerosol inhaler fluticasone/formoterol ( flutiform ® ) . This study compared the efficacy and safety of fluticasone/formoterol with the combination product budesonide/formoterol ( Symbicort ® Turbohaler ® ) . Methods . A r and omized , double-blind , double-dummy , multicenter , Phase 3 study comprising a 7- ( ±3 ) day screening , 2–4-week run-in , and 12-week treatment periods . Patients aged ≥12 years with moderate to severe persistent asthma for ≥6 months before screening and forced expiratory volume in one second ( FEV1 ) 50–80 % predicted and ≥15 % reversibility following salbutamol inhalation were r and omized to fluticasone/formoterol 250/10 μg twice daily ( n = 140 ) or budesonide/formoterol 400/12 μg twice daily ( n = 139 ) . Results . Fluticasone/formoterol was comparable to budesonide/formoterol with respect to the primary endpoint , change in pre-dose FEV1 from baseline to Week 12 . The LS mean treatment difference was −0.044 L , with a lower 95 % confidence interval ( CI ) greater than the pre-defined non-inferiority limit of −0.2 L ( 95 % CI : −0.130 , 0.043 L ; p < 0.001 ) . Non-inferiority was also demonstrated for the secondary endpoints mean change in FEV1 from baseline ( pre-dose ) to 2 hours post-dose at Week 12 , and discontinuations due to lack of efficacy . Similar results were obtained for both treatment groups for all other secondary endpoints . Fluticasone/formoterol had a good safety profile that was comparable with budesonide/formoterol . Conclusions . This study demonstrated comparable efficacy of fluticasone/formoterol to budesonide/formoterol in terms of the primary endpoint , change in pre-dose FEV1 from baseline to Week 12 . This was supported by comparable results for both treatments for all secondary endpoints BACKGROUND Fluticasone and formoterol are well established medications for the treatment of asthma . This study ( Clinical trials.gov identifier : NCT00734318 ) compares the efficacy and safety of a combination of these drugs in a single inhaler ( fluticasone/formoterol ) versus the individual components ( fluticasone + formoterol ) . METHODS Patients aged ≥ 18 years ( n=620 ) with a history of severe , persistent reversible asthma for ≥ 6 months prior to screening were included in this r and omized , double-blind study , which consisted of a screening phase of up to 5 days , a 2-week run-in phase and an 8-week treatment period . RESULTS Fluticasone/formoterol ( 500/20 μg , b.i.d . ) was at least as effective as fluticasone + formoterol ( 500 μg + 24 μg , b.i.d . ) with respect to the primary outcome measure : there were similar increases in mean pre-morning dose forced expiratory volume in the first second ( FEV(1 ) ) in these two groups . Fluticasone/formoterol ( 500/20 μg , b.i.d . ) also demonstrated similar efficacy to fluticasone + formoterol in terms of change in mean FEV(1 ) from baseline pre-morning dose to 2 h post-morning dose at week 8 , as well as for several secondary parameters  . Fluticasone/formoterol ( 500/20 μg , b.i.d . ) demonstrated superiority to fluticasone monotherapy ( 500 μg , b.i.d . ) and fluticasone/formoterol ( 100/10 μg , b.i.d . ) for several secondary efficacy parameters  . Fluticasone/formoterol had a similar safety and tolerability profile to fluticasone + formoterol . CONCLUSION This study demonstrated that the fluticasone/formoterol combination is at least as effective as its components administered concurrently from separate inhalers . Fluticasone/formoterol ( 500/20 μg , b.i.d . ) showed superior efficacy to its inhaled corticosteroid component alone and the efficacy of fluticasone/formoterol was dose-dependent for several clinical ly important parameters BACKGROUND The long-term safety of a new asthma therapy combining fluticasone propionate and formoterol fumarate ( fluticasone/formoterol ; flutiform ( ® ) ) was assessed . METHOD In an open-label study , mild to moderate-severe asthmatics ( ≥12 years ; N=472 ) were treated twice daily with fluticasone/formoterol 100/10 μg ( n=224 ) or 250/10 μg ( n=248 ) for 6 months ( n=256 ) or 12 months ( n=216 ) . The primary and secondary objectives were the long-term safety and efficacy  of fluticasone/formoterol , respectively . RESULTS In total , 413 ( 87.5 % ) patients completed the study ( of which 175 participated for 12 months ) . Adverse events ( AEs ) were reported by 174 patients ( 36.9 % ) : 67 ( 29.9 % ) in the 100/10 μg group and 107 ( 43.1 % ) in the 250/10 μg group . The most common AEs ( > 2 % ) were nasopharyngitis , dyspnea , pharyngitis , and headache ; the majority were mild to moderate . Only 18 ( 3.8 % ) patients reported AEs considered study drug-related . Five patients per group experienced 12 serious AEs ; none was study medication-related . Asthma exacerbations were reported by 53 patients ( 11.2 % ) : 46 mild to moderate and nine severe . Clinical laboratory tests and vital signs showed no abnormal trends or clinical ly important or dose-response-related changes . The efficacy analyses showed statistically significant improvements at every time point throughout the study period at both doses . CONCLUSION Fluticasone/formoterol had a good safety and efficacy profile over the 6- and 12-month study periods Introduction The inhaled corticosteroid , fluticasone propionate ( fluticasone ) , and the long-acting beta2-agonist , formoterol fumarate ( formoterol ) , have been combined in a single aerosol inhaler ( fluticasone/formoterol ) . In a r and omized , open-label study , fluticasone/formoterol showed similar efficacy to fluticasone/salmeterol after 12 weeks of treatment . This post-hoc analysis compared the onset of bronchodilation with the two treatments . Methods Adults with mild-to-moderate-severe persistent asthma were r and omized to fluticasone/formoterol ( 100/10 or 250/10 μg twice daily [ b.i.d . ] ) or fluticasone/salmeterol ( 100/50 or 250/50 μg b.i.d . ) for 12 weeks . The onset of bronchodilation ( the first post-dose time point at which 
    Output:
    
Generally , the incidence of drug-related adverse events was low and consistent with previously reported drug class-related adverse events ( ie , pharyngitis , dysphonia , and headache ) .
The combination of FP-F was shown to be noninferior to fluticasone propionate/salmeterol for improving predose forced expiratory volume at one second ( FEV1 ) and 2 hours post dose FEV1 .
FP-F was also noninferior to budesonide/formoterol in improving predose FEV1 .
Poor asthma control is common .
The data from short-term studies indicate that this inhaled corticosteroid and long-acting beta2 receptor agonist combination product is non-inferior to similar combination products available .
As FP-F is available in different strengths , the corticosteroid dose can be titrated without changing devices .
A potential advantage is that those with good technique , the same type of device could be used for both their controller and rapid relief inhaler medicines .