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Background: No short patient-reported outcome (PRO) instruments assess overall health status across different obstructive lung diseases. Thus, the wording of the introduction to the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) was modified to permit use in asthma and/or COPD. This tool is called the Chronic Airways Assessment Test (CAAT). Methods: The psychometric properties of the CAAT were evaluated using baseline data from the NOVELTY study (NCT02760329) in patients with physician-assigned asthma, asthma + COPD or COPD. Analyses included exploratory/confirmatory factor analyses, differential item functioning and analysis of construct validity. Responses to the CAAT and CAT were compared in patients with asthma + COPD and those with COPD. Results: CAAT items were internally consistent (Cronbach's alpha: > 0.7) within each diagnostic group (n = 510). Models for structural and measurement invariance were strong. Tests of differential item functioning showed small differences between asthma and COPD in individual items, but these were not consistent in direction and had minimal overall impact on the total score. The CAAT and CAT were highly consistent when assessed in all NOVELTY patients who completed both (N = 277, Pearson's correlation coefficient: 0.90). Like the CAT itself, CAAT scores correlated moderately (0.4–0.7) to strongly (> 0.7) with other PRO measures and weakly (< 0.4) with spirometry measures. Conclusions: CAAT scores appear to reflect the same health impairment across asthma and COPD, making the CAAT an appropriate PRO instrument for patients with asthma and/or COPD. Its brevity makes it suitable for use in clinical studies and routine clinical practice. Trial registration: NCT02760329. Plain language summary: Chronic Airways Assessment Test: a questionnaire adapted to assess overall health in asthma and/or COPD What is it about? Asthma and chronic obstructive pulmonary disease (COPD) can have a significant effect on a person's health and wellbeing. For people with these conditions, most of the health questionnaires available for use in patient care are designed for one specific diagnosis – either asthma (e.g. Asthma Control Test) or COPD (e.g. COPD Assessment Test [CAT]). A small number of questionnaires are available for use in both asthma and COPD, but these either take too long to complete, or do not focus on the overall health of patients. Since the symptoms in asthma and COPD overlap, a health questionnaire is needed for use in both asthma and COPD that can be completed during a routine visit to a doctor. This questionnaire could also help with research into the impact of lung diseases in people who have an unclear diagnosis. The CAT was changed so that people with asthma or COPD (or both) could use the same test. We named this new version the Chronic Airways Assessment Test (CAAT). Our goal was to determine whether CAAT scores meant the same level of health in people with asthma, COPD, or both conditions. The CAAT has eight questions, each scored 0 to 5, and takes only a few minutes to complete. The first three questions ask about the person's symptoms, including how often they cough and whether they have chest mucus or chest tightness. The remaining five questions ask how the person's asthma or COPD (or both) affects their daily life. These questions ask about shortness of breath, difficulties doing activities at home, confidence in leaving their home, whether they sleep soundly and how much energy they have. We found that the CAAT performed similarly in people with asthma or COPD (or both). This indicates that the CAAT score means a similar thing for someone with asthma, COPD or both conditions. Why is it important? The CAAT is a quick and simple way for patients to share with their doctor how bad their symptoms are and how much they affect their daily life. The development of the CAAT means that only one questionnaire is needed to measure the effect of a person's symptoms on their current level of health, whether they have asthma, COPD, or both. This will allow doctors to improve the level of care patients receive. [ABSTRACT FROM AUTHOR]

Background: Spirometric small airways obstruction (SAO) is common in the general population. Whether spirometric SAO is associated with respiratory symptoms, cardiometabolic diseases, and quality of life (QoL) is unknown. Methods: Using data from the Burden of Obstructive Lung Disease study (N = 21,594), we defined spirometric SAO as the mean forced expiratory flow rate between 25 and 75% of the FVC (FEF25-75) less than the lower limit of normal (LLN) or the forced expiratory volume in 3 s to FVC ratio (FEV3/FVC) less than the LLN. We analysed data on respiratory symptoms, cardiometabolic diseases, and QoL collected using standardised questionnaires. We assessed the associations with spirometric SAO using multivariable regression models, and pooled site estimates using random effects meta-analysis. We conducted identical analyses for isolated spirometric SAO (i.e. with FEV1/FVC ≥ LLN). Results: Almost a fifth of the participants had spirometric SAO (19% for FEF25-75; 17% for FEV3/FVC). Using FEF25-75, spirometric SAO was associated with dyspnoea (OR = 2.16, 95% CI 1.77–2.70), chronic cough (OR = 2.56, 95% CI 2.08–3.15), chronic phlegm (OR = 2.29, 95% CI 1.77–4.05), wheeze (OR = 2.87, 95% CI 2.50–3.40) and cardiovascular disease (OR = 1.30, 95% CI 1.11–1.52), but not hypertension or diabetes. Spirometric SAO was associated with worse physical and mental QoL. These associations were similar for FEV3/FVC. Isolated spirometric SAO (10% for FEF25-75; 6% for FEV3/FVC), was also associated with respiratory symptoms and cardiovascular disease. Conclusion: Spirometric SAO is associated with respiratory symptoms, cardiovascular disease, and QoL. Consideration should be given to the measurement of FEF25-75 and FEV3/FVC, in addition to traditional spirometry parameters. [ABSTRACT FROM AUTHOR]

Background: No short patient-reported outcome (PRO) instruments assess overall health status across different obstructive lung diseases. Thus, the wording of the introduction to the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) was modified to permit use in asthma and/or COPD. This tool is called the Chronic Airways Assessment Test (CAAT). Methods: The psychometric properties of the CAAT were evaluated using baseline data from the NOVELTY study (NCT02760329) in patients with physician-assigned asthma, asthma + COPD or COPD. Analyses included exploratory/confirmatory factor analyses, differential item functioning and analysis of construct validity. Responses to the CAAT and CAT were compared in patients with asthma + COPD and those with COPD. Results: CAAT items were internally consistent (Cronbach's alpha: > 0.7) within each diagnostic group (n = 510). Models for structural and measurement invariance were strong. Tests of differential item functioning showed small differences between asthma and COPD in individual items, but these were not consistent in direction and had minimal overall impact on the total score. The CAAT and CAT were highly consistent when assessed in all NOVELTY patients who completed both (N = 277, Pearson's correlation coefficient: 0.90). Like the CAT itself, CAAT scores correlated moderately (0.4–0.7) to strongly (> 0.7) with other PRO measures and weakly (< 0.4) with spirometry measures. Conclusions: CAAT scores appear to reflect the same health impairment across asthma and COPD, making the CAAT an appropriate PRO instrument for patients with asthma and/or COPD. Its brevity makes it suitable for use in clinical studies and routine clinical practice. Trial registration: NCT02760329. Plain language summary: Chronic Airways Assessment Test: a questionnaire adapted to assess overall health in asthma and/or COPD What is it about? Asthma and chronic obstructive pulmonary disease (COPD) can have a significant effect on a person's health and wellbeing. For people with these conditions, most of the health questionnaires available for use in patient care are designed for one specific diagnosis – either asthma (e.g. Asthma Control Test) or COPD (e.g. COPD Assessment Test [CAT]). A small number of questionnaires are available for use in both asthma and COPD, but these either take too long to complete, or do not focus on the overall health of patients. Since the symptoms in asthma and COPD overlap, a health questionnaire is needed for use in both asthma and COPD that can be completed during a routine visit to a doctor. This questionnaire could also help with research into the impact of lung diseases in people who have an unclear diagnosis. The CAT was changed so that people with asthma or COPD (or both) could use the same test. We named this new version the Chronic Airways Assessment Test (CAAT). Our goal was to determine whether CAAT scores meant the same level of health in people with asthma, COPD, or both conditions. The CAAT has eight questions, each scored 0 to 5, and takes only a few minutes to complete. The first three questions ask about the person's symptoms, including how often they cough and whether they have chest mucus or chest tightness. The remaining five questions ask how the person's asthma or COPD (or both) affects their daily life. These questions ask about shortness of breath, difficulties doing activities at home, confidence in leaving their home, whether they sleep soundly and how much energy they have. We found that the CAAT performed similarly in people with asthma or COPD (or both). This indicates that the CAAT score means a similar thing for someone with asthma, COPD or both conditions. Why is it important? The CAAT is a quick and simple way for patients to share with their doctor how bad their symptoms are and how much they affect their daily life. The development of the CAAT means that only one questionnaire is needed to measure the effect of a person's symptoms on their current level of health, whether they have asthma, COPD, or both. This will allow doctors to improve the level of care patients receive. [ABSTRACT FROM AUTHOR]

Background: Percutaneous Endoscopic Gastrostomy (PEG) can involve some complications, despite the good safety of its track record. The Buried Bumper Syndrome (BBS) is a rare, late and dangerous complication that consists in the erosion of the internal bumper through the gastric wall. Case presentation We report the development of BBS in a man with chronic obstructive pulmonary disease (COPD) who had a persistent chronic cough which was prevalently but not solely in the morning and required placement of a PEG tube for continuous infusion of Levodopa/carbidopa intestinal gel for advanced Parkinson's disease.Conclusion: We believe that COPD with chronic cough while not representing an absolute contraindication to PEG placement, may potentially cause BBS and therefore an appropriate regimen of tube care by expert personnel is mandatory in this setting. [ABSTRACT FROM AUTHOR]

Chronic obstructive pulmonary disease (COPD) imposes a substantial burden on individuals with the disease, which can include a range of symptoms (breathlessness, cough, sputum production, wheeze, chest tightness) of varying severities. We present an overview of the biomedical literature describing reported relationships between COPD symptoms and disease burden in terms of quality of life, health status, daily activities, physical activity, sleep, comorbid anxiety, and depression, as well as risk of exacerbations and disease prognosis. In addition, the substantial variability of COPD symptoms encountered (morning, daytime, and nighttime) is addressed and their implications for disease burden considered. The findings from this narrative review, which mainly focuses on real-world and observational studies, demonstrate the impact of COPD symptoms on the burden of disease and that improved recognition and understanding of their impact is central to alleviating this burden. [ABSTRACT FROM AUTHOR]

Background: Symptomatic relief is an important treatment goal for patients with COPD. To date, no diary for evaluating respiratory symptoms in clinical trials has been developed and scientifically-validated according to FDA and EMA guidelines. The EXACT - Respiratory Symptoms (E-RS) scale is a patient-reported outcome (PRO) measure designed to address this need. The E-RS utilizes 11 respiratory symptom items from the existing and validated 14-item EXACT, which measures symptoms of exacerbation. The E-RS total score quantifies respiratory symptom severity, and 3 domains assess breathlessness, cough and sputum, and chest symptoms. Methods: This study examined the performance of the E-RS in each of 3 controlled trials with common and unique validation variables: one 6-month (N = 235, US) and two 3-month (N = 749; N = 597; international). Subjects completed the E-RS as part of a daily eDiary. Tests of reliability, validity, and responsiveness were conducted in each dataset. Results: In each study, RS-Total score was internally consistent (Cronbach α) (0.88, 0.92, 0.92) and reproducible (intra-class correlation) in stable patients (2 days apart: 0.91; 7 days apart: 0.71, 0.74). RS-Total scores correlated significantly with the following criterion variables (Spearman's rho; p < 0.01, all comparisons listed here): FEV1% predicted (-0.19, -0.14, -0.15); St. George's Respiratory Questionnaire (SGRQ) (0.65, 0.52, 0.51); Breathlessness, Cough, and Sputum Scale (BCSS) (0.89, 0.89); modified Medical Research Council dyspnoea scale (mMRC) (0.40); rescue medication use (0.43, 0.42); Functional Performance Inventory Short-Form (FPI-SF) (0.43); 6-minute walk distance (6-MWT) (-0.30, -0.14) and incremental shuttle walk (ISWT) (-0.18) tests. Correlations between these variables and RS-Breathlessness, RS-Cough and Sputum, RS-Chest Symptoms scores supported subscale validity. RS-Total, RS-Breathlessness, and RS-Chest Symptoms differentiated mMRC levels of breathlessness severity (p < 0.0001). RS-Total and domain scores differentiated subjects with no rescue medication use and 3 or more puffs (p < 0.0001). Sensitivity to changes in health status (SGRQ), symptoms (BCSS), and exercise capacity (6MWT, ISWT) were also shown and responder definitions using criterion- and distribution-based methods are proposed. Conclusions: Results suggest the E-RS is a reliable, valid, and responsive measure of respiratory symptoms of COPD suitable for use in natural history studies and clinical trials. [ABSTRACT FROM AUTHOR]

Objective Cineole has mucolytic, bronchodilating and anti-inflammatory properties and reduces the exacerbation rate in patients suffering from COPD, as well as ameliorates symptoms in patients suffering from asthma and rhinosinusitis. Based on these effects, we therefore postulated the hypothesis that patients with acute bronchitis would also benefit from therapy with Cineole. Methods As part of a double-blind, placebo-controlled, multi-center-study, a total of 242 patients with confirmed acute bronchitis was randomly selected to participate. Over a period of 10 days, all patients were administered 3 x 200 mg of Cineole, or a respective placebo, per day. The primary outcome measure was a Bronchitis Sum Score, which summarises the relevant symptoms of acute bronchitis. Results After 4 days of treatment it was notable, that the patient group treated with Cineole, showed significantly more improvements of the bronchitis-sum-score than those of the placebo group (p = 0.0383). The statistical significant difference of the individual outcome measures was especially underlined by the frequency of cough fits by p = 0.0001 after 4 days. Conclusions The effects of Cineole in the treatment of acute bronchitis were clearly measurable and could be proven after a treatment period of merely 4 days. This study corroborates the fact that Cineole actively and significantly reduces cough frequency after four days. Therefore it has been shown to have a great socioeconomic impact. Trial registration ISRCTN: ISRCTN37784439 [ABSTRACT FROM AUTHOR]

Background: Macrolides reduce exacerbations in patients with COPD. Their effects on health status has not been assessed as primary outcome and is less clear. This study assessed the effects of prophylactic azithromycin on cough-specific health status in COPD-patients with chronic productive cough. Methods: In this randomised controlled trial 84 patients met the eligibility criteria: age of ⩾40 years, COPD GOLD stage ⩾2 and chronic productive cough. The intervention-group (n = 42) received azithromycin 250 mg 3 times a week and the control-group (n = 42) received a placebo. Primary outcome was cough-specific health status at 12 weeks, measured with the Leicester Cough Questionnaire (LCQ). Secondary outcomes included generic and COPD-specific health status and exacerbations. Changes in adverse events and microbiology were monitored. Results: Mean age of participants was 68 ± 10 years and mean FEV1 was 1.36 ± 0.47 L. The improvement in LCQ total score at 12 weeks was significantly greater with azithromycin (difference 1.3 ± 0.5, 95% CI 0.3;2.3, p = 0.01) and met the minimal clinically important difference. Similar results were found for the domain scores, and COPD-specific and generic health status questionnaires. Other secondary endpoints were non-significant. No imbalances in adverse events were found. Conclusions: Prophylactic azithromycin improved cough-specific health status in COPD-patients with chronic productive cough to a clinically relevant degree. [ABSTRACT FROM AUTHOR]

Over the last 40 years the assessment and treatment of chronic obstructive pulmonary disease has focused primarily on airflow obstruction with little significance given to the problem of cough. The reasons for this include a view that cough arises simply from the direct irritant and inflammatory effect of cigarette smoke or the presence of excess mucus in the airways. Doubt that cough is of any consequence to patients or responsive to current therapies has reinforced this opinion. At odds with this is the emerging evidence that cough impacts adversely on patients' health status and forms an important component of recently validated quality of life instruments. This article presents the arguments why the assessment and treatment of cough should have a more prominent place in the clinical management of COPD. [ABSTRACT FROM AUTHOR]

Background: Recent studies suggest that objectively quantifying coughing in audio recordings offers a novel means to understand coughing and assess treatments. Currently, manual cough counting is the most accurate method for quantifying coughing. However, the demand of manually counting cough records is substantial, demonstrating a need to reduce record lengths prior to counting whilst preserving the coughs within them. This study tested the performance of an algorithm developed for this purpose. Methods: 20 subjects were recruited (5 healthy smokers and non-smokers, 5 chronic cough, 5 chronic obstructive pulmonary disease and 5 asthma), fitted with an ambulatory recording system and recorded for 24 hours. The recordings produced were divided into 15 min segments and counted. Periods of inactive audio in each segment were removed using the median frequency and power of the audio signal and the resulting files re-counted. Results: The median resultant segment length was 13.9 s (IQR 56.4 s) and median 24 hr recording length 62.4 min (IQR 100.4). A median of 0.0 coughs/h (IQR 0.0-0.2) were erroneously removed and the variability in the resultant cough counts was comparable to that between manual cough counts. The largest error was seen in asthmatic patients, but still only 1.0% coughs/h were missed. Conclusions: These data show that a system which measures signal activity using the median audio frequency can substantially reduce record lengths without significantly compromising the coughs contained within them. [ABSTRACT FROM AUTHOR]

Background: Cough recordings have been undertaken for many years but the analysis of cough frequency and the temporal relation to trigger factors have proven problematic. Because cough is episodic, data collection over many hours is required, along with real-time aural analysis which is equally time-consuming. A method has been developed for the automatic recognition and counting of coughs in sound recordings. Methods: The Hull Automatic Cough Counter (HACC) is a program developed for the analysis of digital audio recordings. HACC uses digital signal processing (DSP) to calculate characteristic spectral coefficients of sound events, which are then classified into cough and non-cough events by the use of a probabilistic neural network (PNN). Parameters such as the total number of coughs and cough frequency as a function of time can be calculated from the results of the audio processing. Thirty three smoking subjects, 20 male and 13 female aged between 20 and 54 with a chronic troublesome cough were studied in the hour after rising using audio recordings. Results: Using the graphical user interface (GUI), counting the number of coughs identified by HACC in an hour long recording, took an average of 1 minute 35 seconds, a 97.5% reduction in counting time. HACC achieved a sensitivity of 80% and a specificity of 96%. Reproducibility of repeated HACC analysis is 100%. Conclusion: An automated system for the analysis of sound files containing coughs and other noncough events has been developed, with a high robustness and good degree of accuracy towards the number of actual coughs in the audio recording. [ABSTRACT FROM AUTHOR]

Objective and background: Objective monitoring of cough may be preferred to subjective reporting of the symptom in clinical and research settings. Therefore, a self-contained, ambulatory cough monitoring system is needed that is non-invasive, usable for children and adults of all ages, inexpensive, and highly accurate with easy to use analysis software. Methodology: After development of a new device, 15 subjects with frequent coughing were recorded with the novel cough monitor and a simultaneous video recording in order to validate the monitor compared with a gold standard. Two investigators independently analyzed the recordings and counted the number of coughs during the study period from both the cough monitor and the video recording. Results: When measuring agreement between the two investigators, the sample concordance correlation coefficient for audio counts was 0.998 (p < 0.001). In the comparison of video counts, the sample concordance correlation coefficient was 0.997 (p < 0.001). For the comparison of investigator 1's video counts to the corresponding audio counts, the sample concordance correlation coefficient was 0.968 (p = 0.026). For the comparison of investigator 2's video counts to the corresponding counts, the sample concordance correlation coefficient was 0.973 (p = 0.015). Conclusion: We have developed and piloted a new, valid, and reproducible method of objectively recording and analyzing cough. This device appears to be useful for subjects of any age and in clinical and research settings. [ABSTRACT FROM AUTHOR]

Background: Manual cough counting is time-consuming and laborious; however it is the standard to which automated cough monitoring devices must be compared. We have compared manual cough counting from video recordings with manual cough counting from digital audio recordings. Methods: We studied 8 patients with chronic cough, overnight in laboratory conditions (diagnoses were 5 asthma, 1 rhinitis, 1 gastro-oesophageal reflux disease and 1 idiopathic cough). Coughs were recorded simultaneously using a video camera with infrared lighting and digital sound recording. The numbers of coughs in each 8 hour recording were counted manually, by a trained observer, in real time from the video recordings and using audio-editing software from the digital sound recordings. Results: The median cough frequency was 17.8 (IQR 5.9-28.7) cough sounds per hour in the video recordings and 17.7 (6.0-29.4) coughs per hour in the digital sound recordings. There was excellent agreement between the video and digital audio cough rates; mean difference of -0.3 coughs per hour (SD ± 0.6), 95% limits of agreement -1.5 to +0.9 coughs per hour. Video recordings had poorer sound quality even in controlled conditions and can only be analysed in real time (8 hours per recording). Digital sound recordings required 2-4 hours of analysis per recording. Conclusion: Manual counting of cough sounds from digital audio recordings has excellent agreement with simultaneous video recordings in laboratory conditions. We suggest that ambulatory digital audio recording is therefore ideal for validating future cough monitoring devices, as this as this can be performed in the patients own environment. [ABSTRACT FROM AUTHOR]

Background: Cough variant asthma (CVA) is a cause of chronic cough and a precursor of typical asthma. We retrospectively examined the longitudinal change in bronchial responsiveness and cough reflex sensitivity in CVA patients with respect to the effect of long-term inhaled corticosteroids (ICS). Methods: Provocative concentration of methacholine causing a 20% fall in forced expiratory volume in one second (PC20-FEV1) and provocative concentration of capsaicin eliciting 5 or more coughs (C5) were measured before treatment and during a follow up period following relief of cough (median; 2.0 (range; 0.5 to 8.0) years after the initial visit) in a total of 20 patients with CVA (7 males and 13 females, mean ± SD age of 49.9 ± 12.9 years). Results: Three of 8 patients not taking long-term ICS developed typical asthma compared to none of 12 patients taking ICS (p = 0.0171). PC20-FEV1 significantly (p < 0.0001) increased from 1.80 (GSEM, 1.35) to 10.7 (GSEM, 1.63) mg/ml in patients taking ICS but did not change in patients not taking ICS [2.10 (GSEM, 1.47) compared to 2.13 (GSEM, 1.52) mg/ml]. Cough threshold did not change in patients whether taking or not taking ICS. Conclusion: Long-term ICS reduces bronchial hyperresponsiveness in CVA as recognized in typical asthma. Cough reflex sensitivity is not involved in the mechanism of cough in CVA. [ABSTRACT FROM AUTHOR]

Background: To date, methods used to assess cough have been primarily subjective, and only broadly reflect the impact of chronic cough and/or chronic cough therapies on quality of life. Objective assessment of cough has been attempted, but early techniques were neither ambulatory nor feasible for long-term data collection. We evaluated a novel ambulatory cardio-respiratory monitoring system with an integrated unidirectional, contact microphone, and report here the results from a study of patients with COPD who were videotaped in a quasicontrolled environment for 24 continuous hours while wearing the ambulatory system. Methods: Eight patients with a documented history of COPD with ten or more years of smoking (6 women; age 57.4 ± 11.8 yrs.; percent predicted FEV1 49.6 ± 13.7%) who complained of cough were evaluated in a clinical research unit equipped with video and sound recording capabilities. All patients wore the LifeShirt® system (LS) while undergoing simultaneous video (with sound) surveillance. Video data were visually inspected and annotated to indicate all cough events. Raw physiologic data records were visually inspected by technicians who remained blinded to the video data. Cough events from LS were analyzed quantitatively with a specialized software algorithm to identify cough. The output of the software algorithm was compared to video records on a per event basis in order to determine the validity of the LS system to detect cough in COPD patients. Results: Video surveillance identified a total of 3,645 coughs, while LS identified 3,363 coughs during the same period. The median cough rate per patient was 21.3 coughs·hr-1 (Range: 10.1 cghs·hr-1 - 59.9 cghs·hr-1). The overall accuracy of the LS system was 99.0%. Overall sensitivity and specificity of LS, when compared to video surveillance, were 0.781 and 0.996, respectively, while positive- and negative-predictive values were 0.846 and 0.994. There was very good agreement between the LS system and video (kappa = 0.807). Conclusion: The LS system demonstrated a high level of accuracy and agreement when compared to video surveillance for the measurement of cough in patients with COPD. [ABSTRACT FROM AUTHOR]

Background: Cough is a common reason for patients to visit general practices. So-called post-infectious cough is defined as lasting 3 to 8 weeks after an upper respiratory tract infection. It can be disabling in daily activities, with substantial impact on physical and psychosocial health, leading to impaired quality of life and increased health care costs. Recommendations for the management of post-infectious cough in primary care are scarce and incoherent. A systematic review and meta-analysis of randomized clinical trials (RCT) assessing patient-relevant benefits and potential harms of available treatments identified six eligible RCTs assessing different treatment regimens (i.e. inhaled fluticasone propionate, inhaled budesonide, salbutamol plus ipratropium-bromide, montelukast, nociception-opioid-1-receptor agonist, codeine, gelatine). No RCT found clear patient-relevant benefits and most had an unclear or high risk of bias. Post-infectious cough is thought to be mediated by inflammatory processes that are also present in exacerbations of asthma or chronic obstructive pulmonary diseases for which there is strong evidence that oral corticosteroids provide patient-relevant benefit without relevant harm. We therefore plan to conduct the first RCT evaluating the effectiveness of oral corticosteroids for post-infectious cough.Methods: We are conducting a triple-blinded randomized-controlled and multicentred superiority trial in primary health care practices in Switzerland. We will include 204 adult patients who consult their general practitioner (GP) for a cough lasting 3 to 8 weeks following an upper respiratory tract infection. Participants will be randomly allocated to either the 5-day treatment with oral corticosteroids or placebo. The primary outcome is cough-related quality of life assessed by the Leicester Cough Questionnaire score 14 days after randomization. Secondary outcomes include cough-related quality of life at several time points, overall cessation of cough and adverse events.Discussion: This RCT will provide evidence on whether oral corticosteroids are beneficial and safe in patients with post-infectious cough. Results can have a substantial impact on the well-being and management of these patients in Switzerland and beyond. An evidence-based treatment for this condition may reduce re-consultations with GPs and spending for antitussive drugs, thus possibly having an impact on health care spending.Trial Registration: ClinicalTrials.gov NCT04232449 . Prospectively registered on 18 January 2020. [ABSTRACT FROM AUTHOR]

Background: The COPD Assessment Test (CAT) contains eight items (cough, phlegm, chest tightness, breathlessness, limited activities, confidence leaving home, sleeplessness and energy). The current study aimed 1) to better understand the impact of the respiratory and non-respiratory CAT item scores on the CAT total score; and 2) to determine the impact of pulmonary rehabilitation (PR) on CAT items and CAT total score.Methods: CAT total score of ≥10 or ≥ 18 points was used to classify patients as highly symptomatic, a decrease of 2 points was considered as clinically relevant improvement. 'Cough', 'phlegm', 'chest tightness', 'breathlessness' were defined as respiratory items; ≥3 points on each item was defined as highly symptomatic.Results: In total, 497 clinically stable patients (55% male, age 64.0 (57.5-71.0) years, FEV1 46.0 (32.0-63.0)% predicted, CAT total score 22.0 (17.5-26.0) points) were included. 95% had CAT score ≥ 10 points and 75% ≥18 points. Respectively, 45% and 54% of subjects scored high on 3 or 4 of the respiratory CAT items. Following PR, 220 patients (57.7%) reported an improved health status as assessed by CAT total score (- 3.0 (- 7.0-1.0) points). Change in CAT item scores ranged from 0.0 (- 1.0-0.0) to - 1.0 (- 2.0-0.0) points) with best improvements in 'energy' (- 1.0 (- 2.0-0.0)points).Conclusions: A substantial number of patients classified as highly symptomatic did not report a high level of respiratory symptoms, indicating that non-respiratory symptoms impact on disease classification and treatment algorithm. The impact of PR on CAT item scores varied by individual item.Trial Registration: Netherlands National Trial Register ( NTR3416 ). Registered 2 May 2012. [ABSTRACT FROM AUTHOR]

Background: The impact of COPD on patient's quality of life is well established, but gender differences have received little attention.Methods: To describe factors associated with the health-related quality of life by gender: A cross-sectional observational study (NCT01007734) was conducted in COPD patients followed by pulmonologists. The first patient included had to be a woman. Data concerning the patient, COPD and their management were collected by the physician. The patient had to fill in several questionnaires: Saint-George Hospital respiratory Questionnaire (SGRQ-C), and motivation to quit smoking.Results: Four hundred and thirty patients were included: mean age 63.9 ± 11.3 years; 57.4% were women. Women were significantly younger than men (61.9 vs. 66.6) and their tobacco use was lower (37.1 vs. 40.4 PY). Cardiovascular comorbidities were more frequent in men while osteoporosis, anxiety and depression were frequent in women. The frequency of cough, sputum and the severity of dyspnea did not differ significantly between genders. Lung function impairment was less severe in women than in men (mean FEV1 52% predicted normal vs. 47. 8%). Anxiety score was higher (score 9.8 vs. 7.1) and quality of life (SGRQ-C) more impaired in women (scores 50.6 vs. 45.4; p < 0.02) than in men. Moreover, in multivariate analysis, chronic sputum was associated with higher SGRQ-C scores in women but not in men.Conclusions: This study underlines that despite less airflow limitation, quality of life is more impacted by chronic sputum in women than in men. [ABSTRACT FROM AUTHOR]