***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: Background / Aims Patients with chronic obstructive pulmonary disease ( COPD ) experience more problematic respiratory symptoms and have more trouble performing daily activities in the morning . The aim of this study was to assess the perception of COPD symptoms related to morning activities in patients with severe airflow limitation . Methods Data of 133 patients with severe airflow limitation were analyzed in a prospect i ve , non-interventional study . A clinical symptom question naire was completed by patients at baseline . In patients having morning symptoms , defined by at least one or more prominent or aggravating symptom during morning activities , a morning activity question naire was also completed at baseline and following 2 months of COPD treatment . Results The most frequently reported COPD symptom was breathlessness ( 90.8 % ) . Morning symptoms were reported in 76 ( 57 % ) patients ; these had more frequent and severe clinical COPD symptoms . The most frequently reported morning activity was getting out of bed ( 82.9 % ) . The long acting muscarinic antagonist  ( odds ratio [ OR ] , 6.971 ; 95 % confidence interval [ CI ] , 1.317 to 11.905 ) and chest tightness ( OR , 0.075 ; 95 % CI , 0.011 to 0.518 ) were identified as significantly related to absence of morning symptoms . There was no significant correlation between the degree of forced expiratory volume in 1 second improvement and severity score differences of all items of morning activity after 2-month treatment . Conclusions Fifty-seven percent of COPD patients with severe airflow limitation have morning symptoms that limit their morning activities . These patients also have more prevalent and severe COPD symptoms . The results of this study therefore provide valuable information for the development of patient-reported outcomes in COPD Background The combination of aclidinium bromide , a long-acting anticholinergic , and formoterol fumarate , a long-acting beta2-agonist ( 400/12 μg twice daily ) achieves improvements in lung function greater than either monotherapy in patients with chronic obstructive pulmonary disease ( COPD ) , and is approved in the European Union as a maintenance treatment . The effect of this combination on symptoms of COPD and exacerbations is less well established . We examined these outcomes in a pre-specified analysis of pooled data from two 24-week , double-blind , parallel-group , active- and placebo-controlled , multicentre , r and omised Phase III studies ( ACLIFORM and AUGMENT ) . Methods Patients ≥40 years with moderate to severe COPD ( post-bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity < 70 % and FEV1 ≥30 % but < 80 % predicted normal ) were r and omised ( ACLIFORM : 2:2:2:2:1 ; AUGMENT : 1:1:1:1:1 ) to twice-daily aclidinium/formoterol 400/12 μg or 400/6 μg , aclidinium 400 μg , formoterol 12 μg or placebo via Genuair ™ /Pressair ® . Dyspnoea ( Transition Dyspnoea Index ; TDI ) , daily symptoms ( EXAcerbations of Chronic pulmonary disease Tool [EXACT]-Respiratory Symptoms [ E-RS ] question naire ) , night-time and early-morning symptoms , exacerbations ( Healthcare Re source Utilisation [ HCRU ] and EXACT definitions ) and relief-medication use were assessed . Results The pooled intent-to-treat population included 3394 patients . Aclidinium/formoterol 400/12 μg significantly improved TDI focal score versus placebo and both monotherapies at Week 24 ( all p < 0.05 ) . Over 24 weeks , significant improvements in E-RS total score , overall night-time and early-morning symptom severity and limitation of early-morning activities were observed with aclidinium/formoterol 400/12 μg versus placebo and both monotherapies ( all p < 0.05 ) . The rate of moderate or severe HCRU exacerbations was significantly reduced with aclidinium/formoterol 400/12 μg compared with placebo ( p < 0.05 ) but not monotherapies ; the rate of EXACT-defined exacerbations was significantly reduced with aclidinium/formoterol 400/12 μg versus placebo ( p < 0.01 ) and aclidinium ( p < 0.05 ) . Time to first HCRU or EXACT exacerbation was longer with aclidinium/formoterol 400/12 μg compared with placebo ( all p < 0.05 ) but not the monotherapies . Relief-medication use was reduced with aclidinium/formoterol 400/12 μg versus placebo and aclidinium ( p < 0.01 ) . Conclusions Aclidinium/formoterol 400/12 μg significantly improves 24-hour symptom control compared with placebo , aclidinium and formoterol in patients with moderate to severe COPD . Furthermore , aclidinium/formoterol 400/12 μg reduces the frequency of exacerbations compared with placebo . Trial registration NCT01462942 and NCT01437397 ( Clinical Trials.gov Background Symptoms , particularly dyspnea , and activity limitation , have an impact on the health status and the ability to function normally in patients with chronic obstructive pulmonary disease ( COPD ) . Methods To develop an electronic patient diary ( eDiary ) , qualitative patient interviews were conducted from 2009 to 2010 to identify relevant symptoms and degree of bother due to symptoms . The eDiary was completed by a subset of 209 patients with moderate-to-severe COPD in the 26-week QVA149 SHINE study . Two morning assessment s ( since awakening and since the last assessment ) and one evening assessment were made each day . Assessment s covered five symptoms ( “ shortness of breath , ” “ phlegm/mucus , ” “ chest tightness , ” “ wheezing , ” and “ coughing ” ) and two impact items ( “ bothered by COPD ” and “ difficulty with activities ” ) and were scored on a 10-point numeric scale . Results Patient compliance with the eDiary was 90.4 % at baseline and 81.3 % at week 26 . Correlations between shortness of breath and impact items were > 0.95 . Regression analysis showed that shortness of breath was a highly significant ( P<0.0001 ) predictor of impact items . Exploratory factor analysis gave a single factor comprising all eDiary items , including both symptoms and impact items . Shortness of breath , the total score ( including five symptoms and two impact items ) , and the five-item symptom score from the eDiary performed well , with good consistency and reliability . The eDiary showed good sensitivity to change , with a 0.6 points reduction in the symptoms scores ( on a 0–10 point scale ) representing a meaningful change . Conclusion The eDiary was found to be valid , reliable , and responsive . The high correlations obtained between “ shortness of breath ” and the ratings of “ bother ” and “ difficulty with activities ” confirmed the relevance of this symptom in patients with COPD . Future studies will be required to explore further psychometric properties and their ability to differentiate between COPD treatments Background : Patients with chronic obstructive pulmonary disease ( COPD ) often experience symptoms and problems with activities early in the morning . This is the first study to compare the effect of budesonide/formoterol and salmeterol/fluticasone on lung function , symptoms and activities early in the morning . Methods : Lung function ( peak expiratory flow [ PEF ] and forced expiratory volume in 1 second [ FEV 1 ] ) and symptoms were measured at bedside and activities were measured during the morning using a six-item question naire concerning basic morning routines . In a r and omised , double-blind , multicentre , cross-over study , 442 patients with COPD aged ≥40 years ( pre-bronchodilator FEV1 ≤50 % ; FEV1/vital capacity < 70 % )  received budesonide/formoterol ( 320/9 µg , one inhalation twice daily ) dry powder inhaler ( DPI ) or salmeterol/fluticasone ( 50/500 µg , one inhalation twice daily ) DPI daily , for 1 week each , separated by a 1- to 2-week washout . Lung function ( PEF and FEV1 ) shortly after rising from bed in the morning , symptoms and basic morning activities were assessed by electronic diary ( e-Diary ) recordings . Results : Budesonide/formoterol and salmeterol/fluticasone treatment increased morning PEF 5 minutes post-dose , measured as a mean improvement from baseline over the full study period ( primary endpoint ; adjusted mean change : 15.1 l/min and 14.2 l/min , respectively [ difference 1.0 l/min ; p = 0.603 ] ) . Mean morning FEV1 improved more following budesonide/ formoterol treatment versus salmeterol/fluticasone at 5 minutes ( 0.12 l versus 0.09 l ; p = 0.090 ) and 15 minutes ( 0.14 l versus 0.10 l ; p < 0.05 ) post-dose . Budesonide/formoterol demonstrated a more rapid onset of effect as reflected by increases in e-Diary-recorded PEF and FEV 1 from pre-dose to 5 and 15 minutes post-dose ( all p < 0.001 ) and spirometry at the clinic measured after the first dose ( FEV1 p < 0.001 ; 5 minutes post-dose ) . Improvements in symptom scores within 15 minutes after drug administration were similar for both drugs , but budesonide/formoterol treatment result ed in significantly greater improvements in total morning activities score ( getting washed , dried , dressed , eating breakfast and walking around the home ; 0.22 versus 0.12 respectively , p < 0.05 ) . Both treatments were well tolerated . Conclusions : Short-term treatment with budesonide/formoterol DPI or salmeterol/fluticasone DPI was effective in patients with COPD .  Budesonide/formoterol had a more rapid onset of effect compared with salmeterol/fluticasone and result ed in greater improvements in ability to perform morning activities despite the lower inhaled corticosteroid dose Purpose To test the impact of method of administration ( MOA ) on the measurement characteristics of items developed in the Patient-Reported Outcomes Measurement Information System ( PROMIS ) . Methods Two non-overlapping parallel 8-item forms from each of three PROMIS domains ( physical function , fatigue , and depression ) were completed by 923 adults ( age 18–89 ) with chronic obstructive pulmonary disease , depression , or rheumatoid arthritis . In a r and omized cross-over design , subjects answered one form by interactive voice response ( IVR ) technology , paper question naire ( PQ ) , personal digital assistant ( PDA ) , or personal computer ( PC ) on the Internet , and a second form by PC , in the same administration . Structural invariance , equivalence of item responses , and measurement precision were evaluated using confirmatory factor analysis and item response theory methods . Results Multigroup confirmatory factor analysis supported equivalence of factor structure across MOA . Analyses by item response theory found no differences in item location parameters and strongly supported the equivalence of scores across MOA . Conclusions We found no statistically or clinical ly significant differences in score levels in IVR , PQ , or PDA administration as compared to PC . Availability of large item response theory-calibrated PROMIS item banks allowed for innovations in study design and analysis The quality of reporting of cohort studies published in the most prestigious scientific medical journals was investigated to indicate to what extent the items in the Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) checklist are addressed . Six top scientific medical journals with high impact factor were selected including New Engl and Journal of Medicine , Journal of the American Medical Association , Lancet , British Medical Journal , Archive of Internal Medicine , and Canadian Medical Association Journal . Ten cohort studies published in 2010 were selected r and omly from each journal . The percentage of items in the STROBE checklist that were addressed in each study was investigated . The total percentage of items addressed by these studies was 69.3 ( 95 % confidence interval : 59.6 to 79.0 ) . We concluded that reporting of cohort studies published in the most prestigious scientific medical journals is not clear enough yet . The reporting of other types of observational studies such as case-control and cross-sectional studies particularly those being published in less prestigious journals expected to be much more imprecise In between exacerbations , chronic obstructive pulmonary disease ( COPD ) is usually regarded as a stable condition , but there is increasing recognition of variability in this state . This cross-sectional study assessed patients ' perception of symptom variability . Participants were out patients > 45 yrs old with COPD , current or ex-smokers , forced expiratory volume in 1 s ( FEV1 ) < 50 % predicted , FEV1/forced vital capacity < 0.7 and no exacerbation leading to therapeutic intervention in the previous 3 months . Patients ' perceptions of COPD symptoms and their impact on daily life activities were recorded . Alterations in therapy use in response to COPD worsening were also recorded . COPD symptoms were experienced by 2,258 ( 92.5 % ) out of 2,441 patients during the 7 days before interview . Breathlessness was the most common symptom ( 
    Output:
    
Treatment in line with the guidelines improved the degree of activity limitations due to morning symptoms (p<0.0001).Across all disease stages , COPD patients experience morning symptoms which are negatively associated with physical activity .
Pharmacotherapy may improve the degree of activity limitations due to morning symptoms .