A network meta-analysis of the association between patient traits and response to regular dosing with ICS plus short-acting ß2-agonist reliever or ICS/formoterol reliever only in mild asthma.

INTRODUCTION/BACKGROUND: Mild asthma treatment recommendations include intermittent inhaled corticosteroid (ICS)/formoterol dosing or regular ICS dosing with short-acting ß2-agonist reliever. Due to the heterogeneity of asthma, identification of traits associated with improved outcomes to specific treatments would be clinically beneficial. AIMS/OBJECTIVES: To assess the impact of patient traits on treatment outcomes of regular ICS dosing compared with intermittent ICS/formoterol dosing, a systematic literature review (SLR) and network meta-analysis (NMA) was conducted. Searches identified randomised controlled trials (RCTs) of patients with asthma aged ≥12 years, containing ≥1 regular ICS dosing or intermittent ICS/formoterol dosing treatment arm, reporting traits and outcomes of interest. RESULTS: The SLR identified 11 RCTs of mild asthma, of 14,516 patients. A total of 11 traits and 11 outcomes of interest were identified. Of these, a feasibility assessment indicated possible assessment of three traits (age, baseline lung function, smoking history) and two outcomes (exacerbation rate, change in lung function). The NMA found no significant association of any trait with any outcome with regular ICS dosing relative to intermittent ICS/formoterol dosing. Inconsistent reporting of traits and outcomes between RCTs limited analysis. CONCLUSIONS: This is the first systematic analysis of associations between patient traits and differential treatment outcomes in mild asthma. Although the traits analysed were not found to significantly interact with relative treatment response, inconsistent reporting from the RCTs prevented assessment of some of the most clinically relevant traits and outcomes, such as adherence. More consistent reporting of respiratory RCTs would provide more comparable data and aid future analyses.

[COPD: diagnostic and severity assessment]. / Diagnostic et évaluation de la gravité de la BPCO.

COPD: DIAGNOSTIC AND SEVERITY ASSESSMENT. Chronic obstructive pulmonary disease (COPD) is a frequent and underdiagnosed respiratory disease and a leading cause of morbidity and mortality. It should be suspected in patients aged 40 and over presenting with persistent respiratory symptoms (cough, sputum, shortness of breath, recurrent respiratory tract infections) and a history of exposure to risk factors for the disease (smoking, occupational or domestic exposure to noxious particles). Spirometry is required to confirm the diagnosis of COPD, showing persistent airflow limitation with a post-bronchodilator FEV1/FCV inférieur 0.7. COPD assessment includes: classification of airflow limitation severity with post-bronchodilator FEV1 measurement (GOLD score from 1 to 4), clinical severity assessment (intensity of dyspnea, number and severity of acute exacerbations, impaired quality of life) and evaluation of associated complications (chronic respiratory failure, hypercapnia, pulmonary hypertension). Comorbidities are frequent and should be carefully sought: lung cancer, cardiovascular diseases, metabolic syndrome, skeletal muscle dysfunction, sleep apnea syndrome, osteoporosis, anxiety and depression.

[PAL-PRAT study: Healthcare workers' knowledge and perception of palliative practices in a Cancer Center]. / Quelle connaissance et perception ont les professionnels de santé d'un Centre de lutte contre le cancer à propos des pratiques palliatives encadrées par la loi Claeys-Leonetti : étude PAL PRAT.

INTRODUCTION: The issue of end-of-life care is the subject of a sensitive debate in French society, particularly regarding the possibility for certain patients to have access to medical assistance in dying. The aim of this study was to assess the knowledge and opinion of healthcare providers on the care practices for patients at the end of life, as well as to highlight any specificities in their discourse. METHOD: A survey of healthcare providers' opinions, composed of closed and open questions, that were analyzed using a lexicometric approach, was distributed in a cancer center. RESULTS: The results of the study reveal a good knowledge of the different procedures. Professionals considered that advance directives should be systematically collected; a majority of them differentiated euthanasia from deep continuous sedation and perceived the latter as a means of relieving patients' suffering without inducing death. The different procedures related to the active assistance in dying were known by a majority of professionals and the survey did not identify a dominant trend concerning the will to practice euthanasia if the legal framework allowed it. Half of the participants considered their training insufficient, indicating the need to fill this gap. DISCUSSION: This survey underlines the importance of training and support for the professionals caring for patients in palliative situation and their relatives in France.

Next-Gen GWAS: full 2D epistatic interaction maps retrieve part of missing heritability and improve phenotypic prediction.

The problem of missing heritability requires the consideration of genetic interactions among different loci, called epistasis. Current GWAS statistical models require years to assess the entire combinatorial epistatic space for a single phenotype. We propose Next-Gen GWAS (NGG) that evaluates over 60 billion single nucleotide polymorphism combinatorial first-order interactions within hours. We apply NGG to Arabidopsis thaliana providing two-dimensional epistatic maps at gene resolution. We demonstrate on several phenotypes that a large proportion of the missing heritability can be retrieved, that it indeed lies in epistatic interactions, and that it can be used to improve phenotype prediction.

Prevalence and disparities in influenza vaccination among patients with COPD: A French nationwide population study.

INTRODUCTION: Despite concordant international recommendations, many surveys found disappointing rates of influenza vaccination in at-risk populations, ranging from 23% in overall COPD population to more than 70% in more severe COPD subjects. Therefore, we assessed the proportion of French COPD patients non-vaccinated for influenza and their clinical and socio-demographic factors. MATERIEL AND METHODS: This was a national retrospective study based on the French health insurance database. We identified "diagnosed COPD", defined as subjects hospitalized at least once in 2017 with a principal or associated diagnosis of COPD, and "suspected COPD" as those who were prescribed at least thrice long-acting bronchodilators (LAB), after exclusion of patients with a principal diagnosis or secondary associated diagnosis of asthma or cystic fibrosis, patients deceased before the influenza season and patients hospitalized in long-term or in palliative care unit. Multivariate logistic regression was used to assess the association between patients' characteristics and the lack of influenza vaccination. RESULTS: From the national database, 1 474 396 subjects were identified as "suspected COPD" of whom 528 114 were excluded because of previous diagnosis of asthma or cystic fibrosis, and 350 566 as "diagnosed COPD". Among the 1 296 848 patients included, 646 687 patients (53.3%) were vaccinated against influenza. Non-vaccinated subjects were significantly younger (62.1 vs 71.6 years old), more often women (47.9% vs 43.1%) and had fewer comorbidities assessed by Charlson's index (3.0 ± 2.2 vs 4.3 ± 2.1). Lack of vaccination was also associated with a lower LAB usage. Also, non-vaccinated subjects neither had severe exacerbation during the study period. Besides there was a significant heterogeneity in vaccination rate by geographic region, from 47% to 57%. In multivariate analysis, variables independently associated with the lack of influenza vaccination were female gender, younger age, fewer comorbidities and lower socio-economic level. CONCLUSIONS: This study using the French exhaustive health insurance database shows that influenza vaccination among COPD patients remains dramatically low and must become a high-priority public-health strategy.

Chronic occupational exposures to irritants and asthma in the CONSTANCES cohort.

OBJECTIVES: The impact of chronic occupational exposures to irritants on asthma remains discussed. We studied the associations between occupational exposures and asthma, with specific interest for chronic exposure to irritants, including disinfectants and cleaning products (DCPs) and solvents. METHODS: Cross-sectional analyses included 115 540 adults (55% women, mean age 43 years, 10% current asthma) working at inclusion in the French population-based CONSTANCES cohort (2012-2020). Current asthma was defined by ever asthma with symptoms, medication or asthma attacks (past 12 months), and the asthma symptom score by the sum of 5 respiratory symptoms (past 12 months). Both lifetime and current occupational exposures were assessed by the Occupational Asthma-specific Job-Exposure Matrix. Associations were evaluated by gender using logistic and binomial negative regressions adjusted for age, smoking status and body mass index. RESULTS: In women, associations were observed between current asthma and lifetime exposure to irritants (OR 1.05, 95% CI 1.00 to 1.11), DCPs (1.06, 95% CI 1.00 to 1.12) and solvents (1.06, 95% CI 0.98 to 1.14). In men, only lifetime exposure to DCPs (1.10, 95% CI 1.01 to 1.20) was associated with current asthma. Lifetime exposure to irritants was associated with higher asthma symptom score both in women (mean score ratio: 1.08, 95% CI 1.05 to 1.11) and men (1.11, 95% CI 1.07 to 1.15), especially for DCPs (women: 1.09, 95% CI 1.06 to 1.13, men: 1.21, 95% CI 1.15 to 1.27) and solvents (women 1.14, 95% CI 1.10 to 1.19, men: 1.10, 95% CI 1.05 to 1.15). For current exposures, no consistent associations were observed with current asthma and asthma symptom score. CONCLUSIONS: Lifetime occupational exposures to irritants were associated with current asthma and higher asthma symptom score. These exposures should be carefully considered in asthma management.

Adsorption of anti-inflammatory and analgesic drugs traces in water on clay minerals.

The aim of this study was to assess the adsorption of four non-steroidal anti-inflammatory drugs (NSAIDs), namely Paracetamol (PRC), Diclofenac (DIC), Ibuprofen (IBU), and Ketoprofen (KET), using both batch and continuous experiments with clay. Various analytical techniques, including XRD, FTIR, SEM coupled to EDX, and Zeta potential, were employed to characterize both raw and calcined clay. XRD and FTIR analyses confirmed the kaolinite nature of the clay. SEM data revealed a lamellar structure formed in the clay after calcination at 550 °C. Adsorption tests were conducted to determine the optimal adsorption conditions. Batch kinetics of adsorption demonstrated rapid adsorption of all four NSAIDs, with the highest adsorption occurring at pH 4 (DIC, IBU, and KET) and pH 6 for PRC, using a concentration of 20 mg L-1 of calcined clay. Additionally, the pseudo-second-order model provided the best fit for all NSAIDs adsorption processes. Maximum adsorption capacities, as determined by the Langmuir model, were 80 mg g-1 for PRC, 238 mg -1g for DIC, 138 mg g-1 for IBU, and 245 mg g-1 for KET. In fixed bed column studies, three dynamic models (Thomas, Adams-Bohart, and Yoon-Nelson) were utilized to describe the breakthrough curves, with linear regression used to identify key characteristics for process design. The fixed bed column adsorption study revealed that DIC exhibited the highest removal efficiency at 98%, while KET, IBU, and PRC were more persistent, with removal efficiencies of 77.1%, 76.7%, and 67.1%, respectively. The Thomas model was deemed appropriate for describing the breakthrough curve. These findings offer valuable insights into the interactions between clay and pharmaceuticals with varying physicochemical properties. They also provide information on the adsorption models, saturation, and adsorption capacities of various pharmaceuticals on natural clays, which can be crucial for further research and environmental remediation efforts.

Risk of Pneumonia in Patients with COPD Initiating Fixed Dose Inhaled Corticosteroid (ICS) / Long-Acting Bronchodilator (LABD) Formulations Containing Extrafine Beclometasone Dipropionate versus Patients Initiating LABD Without ICS.

Background: Combined ICS and long-acting bronchodilators (LABD) more effectively reduce COPD exacerbations than LABD therapy alone. Corticosteroid-related adverse effects, including pneumonia, limit ICS use. Previous data suggest this risk is lower for extrafine beclometasone (ef-BDP). We compared pneumonia risk among new users of fixed dose ICS/LABD formulations containing ef-BDP, versus patients initiating LABD without any ICS. Methods: A propensity-matched historical cohort study design used data from OPCRD. COPD patients with ≥1 year of continuous data who initiated LABD or ICS/LABD formulations containing ef-BDP were matched. Primary outcome was time to pneumonia event, as treated, using either sensitive (physician diagnosed) or specific (physician diagnosed and x-ray or hospital admission confirmed) definitions, with non-inferiority boundary of 15%. Results: 23,898 COPD patients were matched, who were 68±11 years, 54.3% male and 56% current-smokers, while 43% were former-smokers. Initiation of ef-BDP/LABD was not associated with an increased risk of pneumonia versus LABD, for either a sensitive 0.89 (0.78-1.02), P = 0.08 or a specific 0.91 (0.78-1.05), P = 0.18 definition of pneumonia. The probability of remaining pneumonia free 1-year after ef-BDP/LABD was 98.4%, which was comparable to LABD at 97.7%, and was sustained up to 6 years of observation; non-inferiority criterion was met for both definitions. Initiation of ef-BDP/LABD was also associated with a reduced risk of developing LRTIs in the propensity matched cohort. Conclusion: Risk of pneumonia when using ICS for the management of COPD reported in several randomised controlled trials may not be relevant with ef-BDP in a diverse real-world clinical population.

Association Between T2-related Comorbidities and Effectiveness of Biologics in Severe Asthma.

Rationale: Previous studies investigating the impact of comorbidities on the effectiveness of biologic agents have been relatively small and of short duration and have not compared classes of biologic agents. Objectives: To determine the association between type 2-related comorbidities and biologic agent effectiveness in adults with severe asthma (SA). Methods: This cohort study used International Severe Asthma Registry data from 21 countries (2017-2022) to quantify changes in four outcomes before and after biologic therapy-annual asthma exacerbation rate, FEV1% predicted, asthma control, and long-term oral corticosteroid daily dose-in patients with or without allergic rhinitis, chronic rhinosinusitis (CRS) with or without nasal polyps (NPs), NPs, or eczema/atopic dermatitis. Measurements and Main Results: Of 1,765 patients, 1,257, 421, and 87 initiated anti-IL-5/5 receptor, anti-IgE, and anti-IL-4/13 therapies, respectively. In general, pre- versus post-biologic therapy improvements were noted in all four asthma outcomes assessed, irrespective of comorbidity status. However, patients with comorbid CRS with or without NPs experienced 23% fewer exacerbations per year (95% CI, 10-35%; P < 0.001) and had 59% higher odds of better post-biologic therapy asthma control (95% CI, 26-102%; P < 0.001) than those without CRS with or without NPs. Similar estimates were noted for those with comorbid NPs: 22% fewer exacerbations and 56% higher odds of better post-biologic therapy control. Patients with SA and CRS with or without NPs had an additional FEV1% predicted improvement of 3.2% (95% CI, 1.0-5.3; P = 0.004), a trend that was also noted in those with comorbid NPs. The presence of allergic rhinitis or atopic dermatitis was not associated with post-biologic therapy effect for any outcome assessed. Conclusions: These findings highlight the importance of systematic comorbidity evaluation. The presence of CRS with or without NPs or NPs alone may be considered a predictor of the effectiveness of biologic agents in patients with SA.

Systematic literature review of traits and outcomes reported in randomised controlled trials of asthma with regular dosing of inhaled corticosteroids with short-acting ß2-agonist reliever, as-needed ICS/formoterol, or ICS/formoterol maintenance and reliever therapy.

INTRODUCTION: Asthma treatments based solely on diagnostic label do not benefit patients equally. To identify patient traits that may be associated with improved treatment response to regular inhaled corticosteroid (ICSs) dosing with short-acting ß2-agonist reliever or ICS/formoterol-containing therapy, a systematic literature review (SLR) was conducted. METHODS: Searches of databases including MEDLINE and Embase identified randomised controlled trials (RCTs) of patients with asthma, aged ≥12 years, published 1998-2022, containing ≥1 regular ICS dosing or ICS/formoterol-containing treatment arm, and reporting patient traits and outcomes of interest. Relevant data was extracted and underwent a feasibility assessment to determine suitability for meta-analysis. RESULTS: The SLR identified 39 RCTs of 72,740 patients and 90 treatment arms, reporting 11 traits and 11 outcomes. Five patient traits (age, body mass index, FEV1, smoking history, asthma control) and five outcomes (exacerbation rate, lung function, asthma control, adherence, time to first exacerbation) were deemed feasible for inclusion in meta-analyses due to sufficient comparable reporting. Subgroups of clinical outcomes stratified by levels of patient traits were reported in 16 RCTs. CONCLUSION: A systematic review of studies of regular ICS dosing with SABA or ICS/formoterol-containing treatment strategies in asthma identified consistent reporting of five traits and outcomes, allowing exploration of associations with treatment response. Conversely, many other traits and outcomes, although being potentially relevant, were inconsistently reported and limited subgroup reporting meant analyses of treatment response for subgroups of traits was not possible. We recommend more consistent measurement and reporting of clinically relevant patient traits and outcomes in respiratory RCTs.

Analysis of comorbidities and multimorbidity in adult patients in the International Severe Asthma Registry.

BACKGROUND: Investigation for the presence of asthma comorbidities is recommended by the Global Initiative for Asthma because their presence can complicate asthma management. OBJECTIVE: To understand the prevalence and pattern of comorbidities and multimorbidity in adults with severe asthma and their association with asthma-related outcomes. METHODS: This was a cross-sectional study using data from the International Severe Asthma Registry from 22 countries. A total of 30 comorbidities were identified and categorized a priori as any of the following: (1) potentially type 2-related comorbidities, (2) potentially oral corticosteroid (OCS)-related comorbidities, or (3) comorbidities mimicking or aggravating asthma. The association between comorbidities and asthma-related outcomes was investigated using multivariable models adjusted for country, age at enrollment, and sex (ie male or female). RESULTS: Of the 11,821 patients, 69%, 67%, and 55% had at least 1 potentially type 2-related, potentially OCS-related, or mimicking or aggravating comorbidities, respectively; 57% had 3 or more comorbidities, and 33% had comorbidities in all 3 categories. Patients with allergic rhinitis, nasal polyposis, and chronic rhinosinusitis experienced 1.12 (P = .003), 1.16 (P < .001), and 1.29 times (P < .001) more exacerbations per year, respectively, than those without. Patients with nasal polyposis and chronic rhinosinusitis were 40% and 46% more likely (P < .001), respectively, to have received long-term (LT) OCS. All assessed potential OCS-related comorbidities (except obesity) were associated with a greater likelihood of LTOCS use (odds ratios [ORs]: 1.23-2.77) and, except for dyslipidemia, with a greater likelihood of uncontrolled asthma (ORs: 1.29-1.68). All mimicking or aggravating comorbidities assessed were associated with more exacerbations (1.24-1.68 times more), all (except bronchiectasis) with increased likelihood of uncontrolled asthma (ORs: 1.57-1.81), and all (except chronic obstructive pulmonary disease) with increased likelihood of LTOCS use (ORs: 1.37-1.57). A greater number of comorbidities was associated with worse outcomes. CONCLUSION: In a global study, comorbidity or multimorbidity is reported in most adults with severe asthma and is associated with poorer asthma-related outcomes. CLINICAL TRIAL REGISTRATION: The International Severe Asthma Registry database has ethical approval from the Anonymous Data Ethics Protocols and Transparency (ADEPT) committee (ADEPT0218) and is registered with the European Union Electronic Register of Post-Authorization Studies (European Network Centres for Pharmacoepidemiology and Pharmacovigilance [ENCEPP]/DSPP/23720). The study was designed, implemented, and reported in compliance with the European Network Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) Code of Conduct (EMA 2014; EUPAS44024) and with all applicable local and international laws and regulations, and registered with ENCEPP (https://www.encepp.eu/encepp/viewResource.htm?id=48848). Governance was provided by ADEPT (registration number: ADEPT1121).

Criterion validity of the spatial exploration test of upper limb mobility to evaluate the active horizontal workspace of children with spinal muscular atrophy.

PURPOSE: To determine the criterion validity of the SET-ULM (Spatial Exploration Test of Upper Limb Mobility), a functional workspace test. MATERIALS AND METHODS: A prospective study from July 2017 to November 2018 in 30 children with SMA type 1 or 2. All children underwent assessment with the SET-ULM and the Motor Function Measure (MFM). RESULTS: We included 30 children. Median (Q1; Q3) MFM D1 (standing ability, ambulation and transfers), D2 (axial and proximal motor function), D3 (distal motor function) scores, Total MFM and Total SET-ULM active score were respectively 2.6% (2.6-3.8); 45.8% (19.9-65.3); 57.7% (36.9-80.9); 35.4% (16.7-43.2) and 70.2% (49.7-97.9). Total SET-ULM active score was strongly correlated with the MFM D2 dimension score (rho 0.82; p < 001), with the D3 dimension (rho 0.86; p < 0.001) and with the Total MFM score (rho 0.89; p < 0.005). Total SET-ULM active score differed between SMA types (p < 0.01). CONCLUSION: The SET-ULM has good criterion validity for the evaluation of available horizontal active upper limb workspace in children with SMA1 and SMA2. Future studies should evaluate reliability and sensitivity to change during a longitudinal follow-up study, as well as in a longitudinal trial of therapeutic effectiveness. CLINICAL TRIALS: NCT03223051IMPLICATIONS FOR REHABILITATIONThe Spatial Exploration Test for Upper Limb Mobility is a useful adjunct to the Motor Function Measure.It provides a precise evaluation of horizontal reaching ability.The Spatial Exploration Test for Upper Limb Mobility will be of great clinical utility for the evaluation of the effects of treatments for spinal muscular atrophy.

Electronic cigarette use and respiratory symptoms in the French population-based Constances cohort.

BACKGROUND: Knowledge about the consequences of electronic cigarette (EC) use on respiratory health is still limited. We aimed to assess whether EC use is associated with the occurrence of asthma symptoms and chronic bronchitis among the French adult population, with a specific focus on never combustible cigarettes (CC) smokers. We further investigated whether the association differed in men and women. METHODS: Constances is a population-based cohort of adults aged 18-69 years at inception. We analyzed baseline data collected in 136,276 participants recruited in 2015-2019. Associations of current and former EC use with respiratory symptoms (asthma symptom score and chronic bronchitis) were assessed, controlling for CC smoking, cannabis use, demographics, education and body mass index (BMI). RESULTS: Increased frequencies of respiratory symptoms were observed in both current and former EC users (for the asthma symptom score, adjusted mean score ratio (aMSR): 1.34 [95 % confidence interval: 1.28-1.41] and 1.39 [1.33-1.45], respectively; for chronic bronchitis, adjusted prevalence ratio (aPR): 1.27 [1.19-1.36] and 1.40 [1.32-1.48], respectively). Among never CC smokers, ever EC use was associated with an increased asthma symptom score in both men and women (aMSR = 1.44 [1.09-1.90] and 1.36 [1.01-1.83], respectively), and with a higher prevalence of chronic bronchitis only in women (aPR = 1.97 [1.27-3.05]). CONCLUSION: EC use is associated with symptoms of asthma and chronic bronchitis, independently of CC smoking and cannabis use. The fact that these associations are observed among individuals who have never smoked tobacco adds further evidence of the deleterious effects of EC on respiratory health.

Real-world super-response to biologics in severe asthma: A French monocentric retrospective cohort study.

BACKGROUND: Biologics have dramatically improved outcomes in severe T2-high asthma. Although the identification of patients with the best response is key to understand the efficacy of these agents and select the best target populations, the definition and predictors of super-response are not fully established yet. METHODS: This study aimed to describe super-response and to identify predictors of super-response to biologics in a French severe eosinophilic asthma cohort followed in a severe asthma tertiary care center between January 2005 and December 2020. Super-response was defined a priori as no oral corticosteroids intake and no exacerbations over 12 months. Collected data at baseline and after 12 months included asthma history, comorbidities, clinical characteristics, lung function, T2-biomarkers, baseline asthma-related treatments, and asthma control. RESULTS: Among 157 patients assessed for eligibility, 108 were included, corresponding to 166 treatments with biologics. Overall response rate was 63.2 % (105/166) and super-response rate was 39.7 % (66/166). In omalizumab group (n = 67), lower dose of oral corticosteroids in maintenance was the only factor associated with super-response (p = 0.008). In the anti-IL-5/anti-IL-5R group (n = 99), absence or lower dose of oral corticosteroids in maintenance and absence of eosinophilic granulomatosis with polyangiitis were statistically associated with super-response (p = 0.009, p = 0.001 and p = 0.02 respectively). CONCLUSION: In this real-life study in severe T2-high asthma patients, a lower dose or absence of daily oral corticosteroids and absence of eosinophilic granulomatosis with polyangiitis were the only identifiable predictors of super-response to biologics. Physicians should not wait for maintenance oral corticosteroids to be required before considering the initiation of a biologic in severe asthma.

Efficacy and safety of oral corticosteroids to treat outpatients with acute exacerbations of COPD in primary care: a multicentre pragmatic randomised controlled study.

Aim: To compare prednisone and placebo for the treatment of outpatients treated for acute exacerbations of chronic obstructive pulmonary disease (COPD) in a primary care setting. Methods: A multicentre, parallel, double-blind, pragmatic randomised controlled trial was performed in France. A total of 66 general practitioners included patients aged ≥40 years with cumulative smoking of ≥10 pack-years and a diagnosis of certain or likely acute exacerbation of COPD. Oral prednisone (40 mg) or placebo were administered daily for 5 days. The main outcome was treatment failure at 8 weeks, defined as a composite criterion based on the occurrence of at least one of the following: unplanned visit to an emergency department or to a practitioner in the ambulatory setting, hospital admission or death. The planned sample size was 202 patients per group. Results: 175 patients were included from February 2015 to May 2017 (43% of the planned sample). All-cause 8-week treatment failure rate was 42.0% in the prednisone group and 34.5% in the placebo group (relative risk 1.22, 95% CI 0.87-1.69, p=0.25). Respiratory-related 8-week treatment failure rate was 27.6% in the prednisone group and 13.6% in the placebo group (relative risk 2.00, 95% CI 1.15-3.57, p=0.015). Conclusion: Although the planned sample size was not achieved, the study does not suggest that oral corticosteroids are more effective than placebo for the treatment of an acute exacerbation of COPD in a primary care setting.

SPLF/SMFU/SRLF/SFAR/SFCTCV Guidelines for the management of patients with primary spontaneous pneumothorax.

INTRODUCTION: Primary spontaneous pneumothorax (PSP) is the presence of air in the pleural space, occurring in the absence of trauma and known lung disease. Standardized expert guidelines on PSP are needed due to the variety of diagnostic methods, therapeutic strategies and medical and surgical disciplines involved in its management. METHODS: Literature review, analysis of the literature according to the GRADE (Grading of Recommendation, Assessment, Development and Evaluation) methodology; proposals for guidelines rated by experts, patients and organizers to reach a consensus. Only expert opinions with strong agreement were selected. RESULTS: A large PSP is defined as presence of a visible rim along the entire axillary line between the lung margin and the chest wall and ≥ 2 cm at the hilum level on frontal chest X-ray. The therapeutic strategy depends on the clinical presentation: emergency needle aspiration for tension PSP; in the absence of signs of severity: conservative management (small PSP), needle aspiration or chest tube drainage (large PSP). Outpatient treatment is possible if a dedicated outpatient care system is previously organized. Indications, surgical procedures and perioperative analgesia are detailed. Associated measures, including smoking cessation, are described. CONCLUSION: These guidelines are a step towards PSP treatment and follow-up strategy optimization in France.