ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evi... more ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evidence related to risk factors, COPD screening, disease prognosis, treatment and exacerbations. Evidence reveals the existence of risk factors for COPD other than tobacco, as well as gender differences in disease presentation. It shows the benefit of screening in an at-risk population, and the predictive value use of multidimensional prognostic indexes. In stable COPD, similar benefits in dyspnea, pulmonary function and quality of life are achieved with LAMA or LABA long-acting bronchodilators, whereas LAMA is more effective in preventing exacerbations. Dual bronchodilator therapy has more benefits than monotherapy. LAMA and combination LABA/IC are similarly effective, but there is an increased risk of pneumonia with LABA/IC. Data on the efficacy and safety of triple therapy are scarce. Evidence supports influenza vaccination in all patients and anti-pneumococcal vaccination in patients < 65 years of age and/or with severe airflow limitation. Antibiotic prophylaxis may decrease exacerbation frequency in patients at risk. The use of systemic corticosteroids and antibiotics is justified in exacerbations requiring hospitalization and in some patients managed in an outpatient setting.
Cystic fibrosis (CF) is characterized by chronic airway infection and inflammation, which account... more Cystic fibrosis (CF) is characterized by chronic airway infection and inflammation, which accounts for most morbidity and deaths. It has been suggested that inflamed airways may increase the exhaled breath temperature (EBT), however, patient with Cystic Fibrosis (CF) may have of the opposite effects. The aim of this study was to measure exhaled breath temperature in adults CF patients by comparison with healthy controls. Fifteen adults CF patients examined (8 female, mean age 28±7 years, VEF1% 44±21%) and 15 healthy persons (7 female, mean age 34±3 years) were recruited for the control group. The measurements of exhaled breath temperature (EBT) were performed with a second generation hand-held device (X-Halo, Delmedical Investments LTD Singapore) using an antibacterial filter (Clear Advantage, Creative Biomedics, Inc). Mean value of EBT in controls was 33.80±0.87°C and EBT mean value in adults CF patients was 33.53±0.73°C, the difference was not significant (p>0.05). We conclude that patients with CF had EBT similarly to healthy people, contrary to the asthmatics patients, possible due to chronic epithelial cell damage, increased mucosal barrier and the reduce of the vascularity.
Introduction Dans l’etude OSMO (Switch de l’Omalizumab au Mepolizumab), des patients non controle... more Introduction Dans l’etude OSMO (Switch de l’Omalizumab au Mepolizumab), des patients non controles de maniere optimale malgre l’administration de fortes doses de corticosteroides inhales et d’un ou plusieurs traitements du fond plus l’omalizumab, ont ete passes a mepolizumab. Cette analyse post hoc a evalue les changements dans les resultats cliniques apres changement de traitement, stratifie selon les quartiles de poids ( Methodes Il s’agissait d’une analyse post-hoc de l’etude OSMO multicentrique, en ouvert, a un seul bras (204471 ; NCT02654145 ). Les patients atteints d’asthme severe a eosinophiles (ASE) non controle traites par l’omalizumab (≥ 4 mois) ont ete passes directement sous mepolizumab 100 mg sous-cutane toutes les 4 semaines pendant 32 semaines. Les criteres d’evaluation incluaient les changements par rapport a l’inclusion du score du questionnaire de controle de l’asthme (ACQ-5) (critere primaire), du score total au questionnaire respiratoire de St George (SGRQ), du volume expiratoire maximal en 1 seconde (VEMS) pre-bronchodilatateur et du taux d’exacerbation. Resultats A la semaine 32 (n = 145 [population en intention de traiter] ; âge moyen : 53,6 ans ; 59 % de femmes), quel que soit le poids ou l’IMC du patient a l’inclusion, ont ete observees des ameliorations marquees du score ACQ-5 (difference minimale cliniquement importante (DMCI) 0,5 ; −1,17 a −1,69), du SGRQ (DMCI 4 ; −11,9 a −23,1) du taux d’exacerbation (rapport de taux [traitement/periode de pretraitement] de 0,23 a 0,56). Les ameliorations moyennes du VEMS pre-bronchodilatateur ont varie parmi les quartiles de poids et d’IMC (DMCI 100 ml ; plage intervalle de −51 a 316 ml et de 66 a 270 ml respectivement), avec la plus petite modification chez ceux Conclusion Globalement, le poids et l’IMC n’ont pas impacte l’efficacite clinique en termes de controle de l’asthme, de l’etat de sante et des taux d’exacerbations suite au switch direct a mepolizumab chez les patients atteints d’ASE non controle par l’omalizumab.
The Journal of Allergy and Clinical Immunology, Feb 1, 2020
RATIONALE: Outcomes from a real-world study reflected the effectiveness of reslizumab in U.S. cli... more RATIONALE: Outcomes from a real-world study reflected the effectiveness of reslizumab in U.S. clinical practice. Here we present the subgroup analyses of patients without CAEs, pre-and post-reslizumab treatment. METHODS: Patient-level data on adults with SEA receiving reslizumab for ≥7 months were collated via a multicenter, retrospective chart review. Patient outcomes during the 6 month pre-and post-reslizumab initiation included FEV 1 percent predicted (FEV 1 PP), healthcare resource usage (HRU), and Asthma Control Test (ACT) scores. RESULTS: A subgroup of 76 non-exacerbating patients were identified from the full study sample (N5215). Statistically significant improvements were seen pre-versus post-reslizumab treatment in FEV 1 PP responses (64.3% vs 72.0%; p<0.001), and ACT scores (14.5 vs 17.6; p<0.001). Clinically meaningful improvements in FEV 1 PP of ≥5% and ACT scores ≥3 points were reported in 60.5% and 51.4% of the subgroup patients, respectively. Significant reductions in HRU were observed preversus post-reslizumab initiation: inpatient admissions, 40.8% vs 18.4% (p<0.001); ER visits, 59.2% vs 31.6% (p<0.001), urgent care visits; 56.1% vs 33.3% (p50.001), unscheduled outpatient visits; 72.9% vs 50.0% (p<0.001). CONCLUSIONS: This real-world reslizumab patient population differed from cohorts treated with anti-IL5 biologics in clinical trials, who were typically selected for prior CAE history. While patients in this subgroup analysis did not have CAEs, pre-or post-reslizumab, their baseline ACT scores indicated a high symptom burden. Study outcomes showed that these patients had clinically meaningful improvements in symptoms and significant reductions in HRU following treatment with reslizumab; suggesting a clinical and economic benefit of reslizumab in clinical practice, even among non-exacerbating patients.
The Journal of Allergy and Clinical Immunology, Feb 1, 2020
RATIONALE: Tezepelumab is a human monoclonal antibody that blocks activity of thymic stromal lymp... more RATIONALE: Tezepelumab is a human monoclonal antibody that blocks activity of thymic stromal lymphopoietin (TSLP), an epithelial cytokine implicated in asthma pathogenesis. In the PATHWAY study (NCT02054130), tezepelumab consistently reduced annualized asthma exacerbation rates (AAER) versus placebo in adults with severe, uncontrolled asthma, irrespective of baseline disease characteristics. This analysis evaluated the efficacy of tezepelumab by baseline body mass index (BMI). METHODS: Patients aged 18-75 years with severe, uncontrolled asthma were randomized to receive subcutaneous tezepelumab (70mg every 4 weeks [Q4W], 210mg Q4W, 280mg every 2 weeks) or placebo, for 52 weeks. AAER was estimated for baseline BMI subgroups of <25, 25 to <30 and ≥30 kg/m 2. RESULTS: Overall, 550 patients were randomized. Lower BMI was associated with younger age, higher baseline blood eosinophil counts and higher fractional exhaled nitric oxide levels. Among placebo recipients, AAER over 52 weeks was similar by BMI subgroup (0.70-0.76 exacerbations per person-year). AAER over 52 weeks was reduced by 79% (95% CI: 57-89), 70% (95% CI: 41-85) and 50% (95% CI: 6-73) for pooled tezepelumab groups versus placebo in patients with a BMI of <25 (n5175), 25 to <30 (n5185) and ≥30 kg/m 2 (n5190), respectively. In the 210mg Q4W dose group, AAER was reduced by 83% (95% CI: 49-94) (n539), 62% (95% CI: 4-85) (n545) and 68% (95% CI: 13-89) (n553), respectively, versus placebo. CONCLUSIONS: Tezepelumab reduced exacerbations in patients with severe, uncontrolled asthma irrespective of baseline BMI, providing further evidence that tezepelumab can meaningfully reduce exacerbations in a broad population of patients with severe asthma.
Aside from IPF, there are no proven therapies for other ILDs with a progressive-fibrosing phenoty... more Aside from IPF, there are no proven therapies for other ILDs with a progressive-fibrosing phenotype that are effective and have tolerable adverse effects. Clinical studies evaluating the benefits of antifibrotic therapy in these populations are underway.
The SCALE project aims to develop a performance questionnaire to assess activities of daily livin... more The SCALE project aims to develop a performance questionnaire to assess activities of daily living (ADL) in COPD patients . Two focus groups of 10 COPD patients each, grouped according to severity, two anthropologist interviews with 6 COPD patients each and qualitative experts evaluations were performed to generate possible items for the initial questionnaire. Four scores of performance of ADL were established: The activity is done without difficulty, the activity is done with difficulty and task modification, the activity is done with a physical help; and the activity is not done, another person does it. The initial questionnaire of 15 items was administered to 30 COPD patients for item reduction. The final questionnaire had 8 questions. This questionnaire was administered to a separate COPD cohort reflecting the whole spectrum of the disease, and a group of healthy subjects. Cross-sectional data were collected from 120 COPD patients, 62+-7 SD age years, 66% male, 30 in each GOLD staging, and 30 healthy subjects. Cronbach9s αwas high for SCALE total score (0.97).Test-retest reliability was determined in all COPD patients in a 2-week interval (Intra Class Coefficient = 0.99). Internal validity was analysed based on the bivariate correlation (Spearman correlation coefficient). There were good correlations with mMRC (rho=0.54; P 1 (rho=-0.43; P We have developed a new questionnaire (SCALE) specially designed to assess the performance of ADL in patients with COPD.
ImportanceThere is a major need for effective, well-tolerated treatments for idiopathic pulmonary... more ImportanceThere is a major need for effective, well-tolerated treatments for idiopathic pulmonary fibrosis (IPF).ObjectiveTo assess the efficacy and safety of the autotaxin inhibitor ziritaxestat in patients with IPF.Design, Setting, and ParticipantsThe 2 identically designed, phase 3, randomized clinical trials, ISABELA 1 and ISABELA 2, were conducted in Africa, Asia-Pacific region, Europe, Latin America, the Middle East, and North America (26 countries). A total of 1306 patients with IPF were randomized (525 patients at 106 sites in ISABELA 1 and 781 patients at 121 sites in ISABELA 2). Enrollment began in November 2018 in both trials and follow-up was completed early due to study termination on April 12, 2021, for ISABELA 1 and on March 30, 2021, for ISABELA 2.InterventionsPatients were randomized 1:1:1 to receive 600 mg of oral ziritaxestat, 200 mg of ziritaxestat, or placebo once daily in addition to local standard of care (pirfenidone, nintedanib, or neither) for at least 52 w...
Additional file 1: Figure S1. Efficacy of switching to mepolizumab from omalizumab by baseline AC... more Additional file 1: Figure S1. Efficacy of switching to mepolizumab from omalizumab by baseline ACQ-5 or SGRQ score quartiles. Figure S2. Efficacy of switching to mepolizumab from omalizumab by baseline body weight or BMI quartiles.
Background The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in... more Background The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudorandom number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178.
Background Although the psychometric properties of patient-reported outcome measures (e.g. the 22... more Background Although the psychometric properties of patient-reported outcome measures (e.g. the 22-item Sino-nasal Outcomes Test [SNOT-22]) in chronic rhinosinusitis with nasal polyps (CRSwNP) have been defined, these definitions have not been extensively studied in patients with very severe CRSwNP, as defined by recurrent disease despite ≥ 1 previous surgery and a current need for further surgery. Therefore, the psychometric properties of the symptoms visual analogue scales (VAS) were evaluated, and meaningful within-patient change thresholds were calculated for VAS and SNOT-22. Methods SYNAPSE (NCT03085797), a randomized, double-blind, placebo-controlled, 52-week trial, assessed the efficacy and safety of 4-weekly mepolizumab 100 mg subcutaneously added to standard of care in very severe CRSwNP. Enrolled patients (n = 407) completed symptom VAS (six items) daily and SNOT-22 every 4 weeks from baseline until Week 52. Blinded psychometric assessment of individual and composite VAS wa...
Introduction: Chronic obstructive pulmonary disease (COPD) is a common airway inflammatory disord... more Introduction: Chronic obstructive pulmonary disease (COPD) is a common airway inflammatory disorder with structural degradation of the airway tissue. Previous reports showed that patients with COPD had EBT lower than normal subjects. Recently, a new combined COPD assessment was established based on the symptoms, spirometric classification and risk of exacerbation (GOLD 2011). Objectives: Evaluate the EBT in COPD patients according to the new combined COPD assessment and compare to healthy subjects. Methods: EBT was measured (using the X-halo, Delmedica, Singapore) in 80 COPD patients (FEV1% 54±14, age 60±8 years, 46 males) and 80 healthy controls. Lung function, COPD Assessment Test (CAT), exacerbations and previous treatment was performed. Results: There was not differences EBT between COPD patients 34,2°C vs healthy subjects 33,9°C. There was no correlation between EBT with FEV1% (r=0,23) and EBT with CAT (r=0,01) but patients with previous exacerbations had EBT more than patients...
Introduction: Chronic obstructive pulmonary disease (COPD) is a preventable disease. The developm... more Introduction: Chronic obstructive pulmonary disease (COPD) is a preventable disease. The development of a simple questionnaire can help to improve the diagnosis. Objective: External validation of the questionnaire to detect COPD in Argentina. Material and Methods: We were performed a questionnaire in subjects with over 40 years old and history of smoking ≥ 10 or more pack / year. Demographic data and pre and post bronchodilator spirometry were performed. Subjects with previous diagnosis of COPD or asthma were excluded. Results. 468 subjects were evaluated.100 (21.1%) had spirometric diagnosis of COPD. In univariate analysis patients with COPD had higher median age (58 years vs 54 years, p Conclusion This simple questionnaire for demographic and clinical data can be useful for detection of COPD.
ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evi... more ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evidence related to risk factors, COPD screening, disease prognosis, treatment and exacerbations. Evidence reveals the existence of risk factors for COPD other than tobacco, as well as gender differences in disease presentation. It shows the benefit of screening in an at-risk population, and the predictive value use of multidimensional prognostic indexes. In stable COPD, similar benefits in dyspnea, pulmonary function and quality of life are achieved with LAMA or LABA long-acting bronchodilators, whereas LAMA is more effective in preventing exacerbations. Dual bronchodilator therapy has more benefits than monotherapy. LAMA and combination LABA/IC are similarly effective, but there is an increased risk of pneumonia with LABA/IC. Data on the efficacy and safety of triple therapy are scarce. Evidence supports influenza vaccination in all patients and anti-pneumococcal vaccination in patients < 65 years of age and/or with severe airflow limitation. Antibiotic prophylaxis may decrease exacerbation frequency in patients at risk. The use of systemic corticosteroids and antibiotics is justified in exacerbations requiring hospitalization and in some patients managed in an outpatient setting.
Cystic fibrosis (CF) is characterized by chronic airway infection and inflammation, which account... more Cystic fibrosis (CF) is characterized by chronic airway infection and inflammation, which accounts for most morbidity and deaths. It has been suggested that inflamed airways may increase the exhaled breath temperature (EBT), however, patient with Cystic Fibrosis (CF) may have of the opposite effects. The aim of this study was to measure exhaled breath temperature in adults CF patients by comparison with healthy controls. Fifteen adults CF patients examined (8 female, mean age 28±7 years, VEF1% 44±21%) and 15 healthy persons (7 female, mean age 34±3 years) were recruited for the control group. The measurements of exhaled breath temperature (EBT) were performed with a second generation hand-held device (X-Halo, Delmedical Investments LTD Singapore) using an antibacterial filter (Clear Advantage, Creative Biomedics, Inc). Mean value of EBT in controls was 33.80±0.87°C and EBT mean value in adults CF patients was 33.53±0.73°C, the difference was not significant (p>0.05). We conclude that patients with CF had EBT similarly to healthy people, contrary to the asthmatics patients, possible due to chronic epithelial cell damage, increased mucosal barrier and the reduce of the vascularity.
Introduction Dans l’etude OSMO (Switch de l’Omalizumab au Mepolizumab), des patients non controle... more Introduction Dans l’etude OSMO (Switch de l’Omalizumab au Mepolizumab), des patients non controles de maniere optimale malgre l’administration de fortes doses de corticosteroides inhales et d’un ou plusieurs traitements du fond plus l’omalizumab, ont ete passes a mepolizumab. Cette analyse post hoc a evalue les changements dans les resultats cliniques apres changement de traitement, stratifie selon les quartiles de poids ( Methodes Il s’agissait d’une analyse post-hoc de l’etude OSMO multicentrique, en ouvert, a un seul bras (204471 ; NCT02654145 ). Les patients atteints d’asthme severe a eosinophiles (ASE) non controle traites par l’omalizumab (≥ 4 mois) ont ete passes directement sous mepolizumab 100 mg sous-cutane toutes les 4 semaines pendant 32 semaines. Les criteres d’evaluation incluaient les changements par rapport a l’inclusion du score du questionnaire de controle de l’asthme (ACQ-5) (critere primaire), du score total au questionnaire respiratoire de St George (SGRQ), du volume expiratoire maximal en 1 seconde (VEMS) pre-bronchodilatateur et du taux d’exacerbation. Resultats A la semaine 32 (n = 145 [population en intention de traiter] ; âge moyen : 53,6 ans ; 59 % de femmes), quel que soit le poids ou l’IMC du patient a l’inclusion, ont ete observees des ameliorations marquees du score ACQ-5 (difference minimale cliniquement importante (DMCI) 0,5 ; −1,17 a −1,69), du SGRQ (DMCI 4 ; −11,9 a −23,1) du taux d’exacerbation (rapport de taux [traitement/periode de pretraitement] de 0,23 a 0,56). Les ameliorations moyennes du VEMS pre-bronchodilatateur ont varie parmi les quartiles de poids et d’IMC (DMCI 100 ml ; plage intervalle de −51 a 316 ml et de 66 a 270 ml respectivement), avec la plus petite modification chez ceux Conclusion Globalement, le poids et l’IMC n’ont pas impacte l’efficacite clinique en termes de controle de l’asthme, de l’etat de sante et des taux d’exacerbations suite au switch direct a mepolizumab chez les patients atteints d’ASE non controle par l’omalizumab.
The Journal of Allergy and Clinical Immunology, Feb 1, 2020
RATIONALE: Outcomes from a real-world study reflected the effectiveness of reslizumab in U.S. cli... more RATIONALE: Outcomes from a real-world study reflected the effectiveness of reslizumab in U.S. clinical practice. Here we present the subgroup analyses of patients without CAEs, pre-and post-reslizumab treatment. METHODS: Patient-level data on adults with SEA receiving reslizumab for ≥7 months were collated via a multicenter, retrospective chart review. Patient outcomes during the 6 month pre-and post-reslizumab initiation included FEV 1 percent predicted (FEV 1 PP), healthcare resource usage (HRU), and Asthma Control Test (ACT) scores. RESULTS: A subgroup of 76 non-exacerbating patients were identified from the full study sample (N5215). Statistically significant improvements were seen pre-versus post-reslizumab treatment in FEV 1 PP responses (64.3% vs 72.0%; p<0.001), and ACT scores (14.5 vs 17.6; p<0.001). Clinically meaningful improvements in FEV 1 PP of ≥5% and ACT scores ≥3 points were reported in 60.5% and 51.4% of the subgroup patients, respectively. Significant reductions in HRU were observed preversus post-reslizumab initiation: inpatient admissions, 40.8% vs 18.4% (p<0.001); ER visits, 59.2% vs 31.6% (p<0.001), urgent care visits; 56.1% vs 33.3% (p50.001), unscheduled outpatient visits; 72.9% vs 50.0% (p<0.001). CONCLUSIONS: This real-world reslizumab patient population differed from cohorts treated with anti-IL5 biologics in clinical trials, who were typically selected for prior CAE history. While patients in this subgroup analysis did not have CAEs, pre-or post-reslizumab, their baseline ACT scores indicated a high symptom burden. Study outcomes showed that these patients had clinically meaningful improvements in symptoms and significant reductions in HRU following treatment with reslizumab; suggesting a clinical and economic benefit of reslizumab in clinical practice, even among non-exacerbating patients.
The Journal of Allergy and Clinical Immunology, Feb 1, 2020
RATIONALE: Tezepelumab is a human monoclonal antibody that blocks activity of thymic stromal lymp... more RATIONALE: Tezepelumab is a human monoclonal antibody that blocks activity of thymic stromal lymphopoietin (TSLP), an epithelial cytokine implicated in asthma pathogenesis. In the PATHWAY study (NCT02054130), tezepelumab consistently reduced annualized asthma exacerbation rates (AAER) versus placebo in adults with severe, uncontrolled asthma, irrespective of baseline disease characteristics. This analysis evaluated the efficacy of tezepelumab by baseline body mass index (BMI). METHODS: Patients aged 18-75 years with severe, uncontrolled asthma were randomized to receive subcutaneous tezepelumab (70mg every 4 weeks [Q4W], 210mg Q4W, 280mg every 2 weeks) or placebo, for 52 weeks. AAER was estimated for baseline BMI subgroups of <25, 25 to <30 and ≥30 kg/m 2. RESULTS: Overall, 550 patients were randomized. Lower BMI was associated with younger age, higher baseline blood eosinophil counts and higher fractional exhaled nitric oxide levels. Among placebo recipients, AAER over 52 weeks was similar by BMI subgroup (0.70-0.76 exacerbations per person-year). AAER over 52 weeks was reduced by 79% (95% CI: 57-89), 70% (95% CI: 41-85) and 50% (95% CI: 6-73) for pooled tezepelumab groups versus placebo in patients with a BMI of <25 (n5175), 25 to <30 (n5185) and ≥30 kg/m 2 (n5190), respectively. In the 210mg Q4W dose group, AAER was reduced by 83% (95% CI: 49-94) (n539), 62% (95% CI: 4-85) (n545) and 68% (95% CI: 13-89) (n553), respectively, versus placebo. CONCLUSIONS: Tezepelumab reduced exacerbations in patients with severe, uncontrolled asthma irrespective of baseline BMI, providing further evidence that tezepelumab can meaningfully reduce exacerbations in a broad population of patients with severe asthma.
Aside from IPF, there are no proven therapies for other ILDs with a progressive-fibrosing phenoty... more Aside from IPF, there are no proven therapies for other ILDs with a progressive-fibrosing phenotype that are effective and have tolerable adverse effects. Clinical studies evaluating the benefits of antifibrotic therapy in these populations are underway.
The SCALE project aims to develop a performance questionnaire to assess activities of daily livin... more The SCALE project aims to develop a performance questionnaire to assess activities of daily living (ADL) in COPD patients . Two focus groups of 10 COPD patients each, grouped according to severity, two anthropologist interviews with 6 COPD patients each and qualitative experts evaluations were performed to generate possible items for the initial questionnaire. Four scores of performance of ADL were established: The activity is done without difficulty, the activity is done with difficulty and task modification, the activity is done with a physical help; and the activity is not done, another person does it. The initial questionnaire of 15 items was administered to 30 COPD patients for item reduction. The final questionnaire had 8 questions. This questionnaire was administered to a separate COPD cohort reflecting the whole spectrum of the disease, and a group of healthy subjects. Cross-sectional data were collected from 120 COPD patients, 62+-7 SD age years, 66% male, 30 in each GOLD staging, and 30 healthy subjects. Cronbach9s αwas high for SCALE total score (0.97).Test-retest reliability was determined in all COPD patients in a 2-week interval (Intra Class Coefficient = 0.99). Internal validity was analysed based on the bivariate correlation (Spearman correlation coefficient). There were good correlations with mMRC (rho=0.54; P 1 (rho=-0.43; P We have developed a new questionnaire (SCALE) specially designed to assess the performance of ADL in patients with COPD.
ImportanceThere is a major need for effective, well-tolerated treatments for idiopathic pulmonary... more ImportanceThere is a major need for effective, well-tolerated treatments for idiopathic pulmonary fibrosis (IPF).ObjectiveTo assess the efficacy and safety of the autotaxin inhibitor ziritaxestat in patients with IPF.Design, Setting, and ParticipantsThe 2 identically designed, phase 3, randomized clinical trials, ISABELA 1 and ISABELA 2, were conducted in Africa, Asia-Pacific region, Europe, Latin America, the Middle East, and North America (26 countries). A total of 1306 patients with IPF were randomized (525 patients at 106 sites in ISABELA 1 and 781 patients at 121 sites in ISABELA 2). Enrollment began in November 2018 in both trials and follow-up was completed early due to study termination on April 12, 2021, for ISABELA 1 and on March 30, 2021, for ISABELA 2.InterventionsPatients were randomized 1:1:1 to receive 600 mg of oral ziritaxestat, 200 mg of ziritaxestat, or placebo once daily in addition to local standard of care (pirfenidone, nintedanib, or neither) for at least 52 w...
Additional file 1: Figure S1. Efficacy of switching to mepolizumab from omalizumab by baseline AC... more Additional file 1: Figure S1. Efficacy of switching to mepolizumab from omalizumab by baseline ACQ-5 or SGRQ score quartiles. Figure S2. Efficacy of switching to mepolizumab from omalizumab by baseline body weight or BMI quartiles.
Background The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in... more Background The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudorandom number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178.
Background Although the psychometric properties of patient-reported outcome measures (e.g. the 22... more Background Although the psychometric properties of patient-reported outcome measures (e.g. the 22-item Sino-nasal Outcomes Test [SNOT-22]) in chronic rhinosinusitis with nasal polyps (CRSwNP) have been defined, these definitions have not been extensively studied in patients with very severe CRSwNP, as defined by recurrent disease despite ≥ 1 previous surgery and a current need for further surgery. Therefore, the psychometric properties of the symptoms visual analogue scales (VAS) were evaluated, and meaningful within-patient change thresholds were calculated for VAS and SNOT-22. Methods SYNAPSE (NCT03085797), a randomized, double-blind, placebo-controlled, 52-week trial, assessed the efficacy and safety of 4-weekly mepolizumab 100 mg subcutaneously added to standard of care in very severe CRSwNP. Enrolled patients (n = 407) completed symptom VAS (six items) daily and SNOT-22 every 4 weeks from baseline until Week 52. Blinded psychometric assessment of individual and composite VAS wa...
Introduction: Chronic obstructive pulmonary disease (COPD) is a common airway inflammatory disord... more Introduction: Chronic obstructive pulmonary disease (COPD) is a common airway inflammatory disorder with structural degradation of the airway tissue. Previous reports showed that patients with COPD had EBT lower than normal subjects. Recently, a new combined COPD assessment was established based on the symptoms, spirometric classification and risk of exacerbation (GOLD 2011). Objectives: Evaluate the EBT in COPD patients according to the new combined COPD assessment and compare to healthy subjects. Methods: EBT was measured (using the X-halo, Delmedica, Singapore) in 80 COPD patients (FEV1% 54±14, age 60±8 years, 46 males) and 80 healthy controls. Lung function, COPD Assessment Test (CAT), exacerbations and previous treatment was performed. Results: There was not differences EBT between COPD patients 34,2°C vs healthy subjects 33,9°C. There was no correlation between EBT with FEV1% (r=0,23) and EBT with CAT (r=0,01) but patients with previous exacerbations had EBT more than patients...
Introduction: Chronic obstructive pulmonary disease (COPD) is a preventable disease. The developm... more Introduction: Chronic obstructive pulmonary disease (COPD) is a preventable disease. The development of a simple questionnaire can help to improve the diagnosis. Objective: External validation of the questionnaire to detect COPD in Argentina. Material and Methods: We were performed a questionnaire in subjects with over 40 years old and history of smoking ≥ 10 or more pack / year. Demographic data and pre and post bronchodilator spirometry were performed. Subjects with previous diagnosis of COPD or asthma were excluded. Results. 468 subjects were evaluated.100 (21.1%) had spirometric diagnosis of COPD. In univariate analysis patients with COPD had higher median age (58 years vs 54 years, p Conclusion This simple questionnaire for demographic and clinical data can be useful for detection of COPD.
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Papers by Miguel Bergna