Comparison of the efficacy and safety of nebulized beclometasone dipropionate and budesonide in severe persistent childhood asthma

AbstractInhaled steroids are recommended for long-term control of asthma, but their use may be limited in young children because of difficulties in using the associated inhaler device. The use of nebulizers may help to overcome this issue, without compromising therapeutic efficacy or safety. This 14-week, multicentre, randomized, controlled, open-label, parallel-group study compared the efficacy and safety of nebulized corticosteroids in paediatric patients (aged 6 months to 6 years) with severe persistent asthma. Beclometasone dipropionate (BDP) 800 μg day−1 suspension for nebulization and budesonide (BUD) 750 μg day−1 given by nebulization in a twice-daily regimen, and when used in addition to the usual maintenance therapy, resulted in comparable clinical efficacy across all parameters. The primary efficacy endpoint was the number of patients who did not experience any major exacerbation, this being 40·4% and 51·7% in the BDP and BUD groups respectively in the ITT population (P=0·28), and the mean number of global exacerbations (major plus minor) decreased respectively by −37.5% in the BDP group and −23.3% in the BUD group. Both treatments were also associated with marked reductions in the number of nights with wheezing and the number of days of oral steroid use. Moreover, the two treatment groups had a similar adverse-event incidence and profile. Only 11 adverse events were reported, and no serious adverse events were related to treatment. Urinary cortisol and the time course of height and weight were unaffected by both treatments, and BDP was confirmed to have a neutral effect on bone metabolism. In conclusion, this study demonstrates that both BDP 800 μg day−1 suspension for nebulization and BUD 750 μg day−1 administered by nebulization are effective, with an acceptable safety profile, for treatment of severe persistent asthma in infants and young children

Thoracoscopic Assessment of Pleural Tumor Burden in Patients with Malignant Pleural Effusion: Prognostic and Therapeutic Implications

Background:Malignant pleural effusion (MPE) is encountered at an advanced stage of disease progression and often heralds a poor prognosis. The most reliable predictive factor of survival in such patients is the primary tumor. Thoracoscopy is often performed for accurate diagnosis and/or thoracoscopic talc insufflation as a therapeutic modality. It remains unknown whether pleural tumor burden, as visualized on thoracoscopy, has potential prognostic value. The objective of this study was to determine the prognostic accuracy of pleural tumor extent and localization (parietal, visceral, or diaphragmatic involvement), as assessed during medical thoracoscopy.Methods:Medical records of all patients who underwent thoracoscopy for suspicion of MPE between 2001 and 2008 at a tertiary care referral hospital were reviewed. Patients were included if pleural metastatic invasion was confirmed on tissue biopsy and survival status ascertained.Results:Four hundred twenty-one patients underwent diagnostic or therapeutic medical thoracoscopy at our referral center. Among them, 122 had confirmed metastatic pleural spread, but survival data were lacking in 15. Primary tumor consisted of non-mall cell lung cancer in 56, breast cancer in 23, melanoma in eight, and other malignancies in 20. Median survival of the entire population was 9.4 months. On univariate analysis, the following variables were significantly associated with reduced median overall survival: pleural metastatic melanoma, age less than 60 years, bloody MPE, extensive pleural adhesions, and widespread visceral pleural nodules (p < 0.05). On multivariate analysis, only melanoma as a primary tumor, pleural fluid appearance and extent of pleural adhesions remained independent and significant predictors of survival.Conclusion:No significant association was found between the extent or localization of pleural tumor burden and overall survival

An eleven-year retrospective cross-sectional study on pulmonary alveolar proteinosis

Introduction: Pulmonary alveolar proteinosis (PAP) is a rare disease in the field of pulmonary medicine. The efficacy of whole-lunglavage (WLL) as the treatment of PAP had never been evaluated in the Iranian population. Therefore, there is a real need to investigatethe characteristics of PAP and also to evaluate the efficacy of WLL in this rare disease. The study aimed to investigatedemographic features, clinical presentation and treatment outcomes of the disease in Iranian PAP patients. Material and methods: Data of 45 patients with definite diagnosis of PAP, who had regular follow-ups from March 2004 to March2015 at an Iranian referral respiratory hospital, were collected. Whole-lung lavages (WLL) efficacy was assessed by comparingspirometric, arterial blood gas parameters and six-minute walk test (6MWT) results before and after all lavages. Results: Mean age at diagnosis of disease was 30.33 ± 14.56 years. Four patients (8.8%) reported non-massive hemoptysis and threesubjects (6.6%) had concomitant pulmonary tuberculosis. In 71.1% of cases, transbronchial lung biopsy and bronchoalveolar lavage weresufficient for diagnosis. Spirometric results and arterial blood gas parameters and 6MWD improved significantly after all the lavages. Fourpatients (8.8%) died because of respiratory failure. The only variable capable of predicting treatment failure was the history of hemoptysis. Conclusion: The study revealed sufficiency of WLL as the PAP patients’ treatment. Also hemoptysis was found to be the independentfactor that can predict treatment failure

Jedenastoletnie, retrospektywne badanie przekrojowe dotyczące proteinozy pęcherzyków płucnych

WSTĘP: Proteinoza pęcherzyków płucnych (PAP, pulmonary alveolar proteinosis) to rzadka choroba płuc. W populacji irańskiej nie analizowano nigdy skuteczności płukania całego płuca (WLL, whole-lung lavage) jako leczenia PAP. Z tego powodu oceniono charakterystykę PAP, a także skuteczność WLL w tej rzadkiej chorobie. Niniejsze badanie miało na celu analizę cech demograficznych, obrazu klinicznego i wyników leczenie tej choroby u irańskich pacjentów z PAP. MATERIAŁ I METODY: Zgromadzono dane 45 pacjentów z pewnym rozpoznaniem PAP, regularnie obserwowanych od marca 2004 do marca 2015 roku w irańskim szpitalu referencyjnym. Skuteczność WLL oceniano, porównując parametry spirometryczne, gazometrii krwi tętniczej oraz testu 6-minutowego marszu (6MWT, 6 minute walk test) przed i po wykonaniu wszystkich zabiegów płukania płuca. WYNIKI: Średni wiek w momencie rozpoznania choroby wynosił 30,33 ± 14,56 roku. U czterech pacjentów (8,8%) występowało niemasywne krwioplucie, u trzech (6,6%) współistniała gruźlica płuc. Biopsja przezoskrzelowa płuca i płukanie oskrzelowo- -pęcherzykowe w 71,1% przypadków były wystarczającymi badaniami do postawienia rozpoznania. Wyniki spirometryczne, parametry gazometrii krwi tętniczej i 6MWD poprawiły się znamiennie po przeprowadzeniu wszystkich zabiegów płukania płuca. Czterech pacjentów (8,8%) zmarło z powodu niewydolności oddechowej. Jedyną zmienną mogącą przewidzieć niepowodzenie leczenia było występowanie krwioplucia w wywiadzie chorobowym. WNIOSKI: W badaniu wykazano, że WLL jest leczeniem skutecznym u pacjentów z PAP. Krwioplucie było niezależnym czynnikiem predykcyjnym niepowodzenia leczenia.WSTĘP: Proteinoza pęcherzyków płucnych (PAP, pulmonary alveolar proteinosis) to rzadka choroba płuc. W populacji irańskiej nie analizowano nigdy skuteczności płukania całego płuca (WLL, whole-lung lavage) jako leczenia PAP. Z tego powodu oceniono charakterystykę PAP, a także skuteczność WLL w tej rzadkiej chorobie. Niniejsze badanie miało na celu analizę cech demograficznych, obrazu klinicznego i wyników leczenie tej choroby u irańskich pacjentów z PAP. MATERIAŁ I METODY: Zgromadzono dane 45 pacjentów z pewnym rozpoznaniem PAP, regularnie obserwowanych od marca 2004 do marca 2015 roku w irańskim szpitalu referencyjnym. Skuteczność WLL oceniano, porównując parametry spirometryczne, gazometrii krwi tętniczej oraz testu 6-minutowego marszu (6MWT, 6 minute walk test) przed i po wykonaniu wszystkich zabiegów płukania płuca. WYNIKI: Średni wiek w momencie rozpoznania choroby wynosił 30,33 ± 14,56 roku. U czterech pacjentów (8,8%) występowało niemasywne krwioplucie, u trzech (6,6%) współistniała gruźlica płuc. Biopsja przezoskrzelowa płuca i płukanie oskrzelowo- -pęcherzykowe w 71,1% przypadków były wystarczającymi badaniami do postawienia rozpoznania. Wyniki spirometryczne, parametry gazometrii krwi tętniczej i 6MWD poprawiły się znamiennie po przeprowadzeniu wszystkich zabiegów płukania płuca. Czterech pacjentów (8,8%) zmarło z powodu niewydolności oddechowej. Jedyną zmienną mogącą przewidzieć niepowodzenie leczenia było występowanie krwioplucia w wywiadzie chorobowym. WNIOSKI: W badaniu wykazano, że WLL jest leczeniem skutecznym u pacjentów z PAP. Krwioplucie było niezależnym czynnikiem predykcyjnym niepowodzenia leczenia

A Survey of the European Association of Bronchology and Interventional Pulmonology (EABIP)

Publisher Copyright: © Copyright 2017 S. Karger AG, Basel. All rights reserved.Background: Airway stenting (AS) commenced in Europe circa 1987 with the first placement of a dedicated silicone airway stent. Subsequently, over the last 3 decades, AS was spread throughout Europe, using different insertion techniques and different types of stents. Objectives: This study is an international survey conducted by the European Association of Bronchology and Interventional Pulmonology (EABIP) focusing on AS practice within 26 European countries. Methods: A questionnaire was sent to all EABIP National Delegates in February 2015. National delegates were responsible for obtaining precise and objective data regarding the current AS practice in their country. The deadline for data collection was February 2016. Results: France, Germany, and the UK are the 3 leading countries in terms of number of centres performing AS. These 3 nations represent the highest ranked nations within Europe in terms of gross national income. Overall, pulmonologists perform AS exclusively in 5 countries and predominately in 12. AS is performed almost exclusively in public hospitals. AS performed under general anaesthesia is the rule for the majority of institutions, and local anaesthesia is an alternative in 9 countries. Rigid bronchoscopy techniques are predominant in 20 countries. Amongst commercially available stents, both Dumon and Ultraflex are by far the most commonly deployed. Finally, 11 countries reported that AS is an economically viable activity, while 10 claimed that it is not. Conclusion: This EABIP survey demonstrates that there is significant heterogeneity in AS practice within Europe. Therapeutic bronchoscopy training and economic issues/reimbursement for procedures are likely to be the primary reasons explaining these findings.publishersversionpublishe

Current Practice of Airway Stenting in the Adult Population in Europe: A Survey of the European Association of Bronchology and Interventional Pulmonology (EABIP)

Background: Airway stenting (AS) commenced in Europe circa 1987 with the first placement of a dedicated silicone airway stent. Subsequently, over the last 3 decades, AS was spread throughout Europe, using different insertion techniques and different types of stents. Objectives: This study is an international survey conducted by the European Association of Bronchology and Interventional Pulmonology (EABIP) focusing on AS practice within 26 European countries. Methods: A questionnaire was sent to all EABIP National Delegates in February 2015. National delegates were responsible for obtaining precise and objective data regarding the current AS practice in their country. The deadline for data collection was February 2016. Results: France, Germany, and the UK are the 3 leading countries in terms of number of centres performing AS. These 3 nations represent the highest ranked nations within Europe in terms of gross national income. Overall, pulmonologists perform AS exclusively in 5 countries and predominately in 12. AS is performed almost exclusively in public hospitals. AS performed under general anaesthesia is the rule for the majority of institutions, and local anaesthesia is an alternative in 9 countries. Rigid bronchoscopy techniques are predominant in 20 countries. Amongst commercially available stents, both Dumon and Ultraflex are by far the most commonly deployed. Finally, 11 countries reported that AS is an economically viable activity, while 10 claimed that it is not. Conclusion: This EABIP survey demonstrates that there is significant heterogeneity in AS practice within Europe. Therapeutic bronchoscopy training and economic issues/reimbursement for procedures are likely to be the primary reasons explaining these findings. (C) 2017 S. Karger AG, Base

Post tracheostomy and post intubation tracheal stenosis: Report of 31 cases and review of the literature

<p>Abstract</p> <p>Background</p> <p>Severe post tracheostomy (PT) and post intubation (PI) tracheal stenosis is an uncommon clinical entity that often requires interventional bronchoscopy before surgery is considered. We present our experience with severe PI and PT stenosis in regards to patient characteristics, possible risk factors, and therapy.</p> <p>Methods</p> <p>We conducted a retrospective chart review of 31 patients with PI and PT stenosis treated at Lahey Clinic over the past 8 years. Demographic characteristics, body mass index, co-morbidities, stenosis type and site, procedures performed and local treatments applied were recorded.</p> <p>Results</p> <p>The most common profile of a patient with tracheal stenosis in our series was a female (75%), obese (66%) patient with a history of diabetes mellitus (35.4%), hypertension (51.6%), and cardiovascular disease (45.1%), who was a current smoker (38.7%). Eleven patients (PI group) had only oro-tracheal intubation (5.2 days of intubation) and developed web-like stenosis at the cuff site. Twenty patients (PT group) had undergone tracheostomy (54.5 days of intubation) and in 17 (85%) of them the stenosis appeared around the tracheal stoma. There was an average of 2.4 procedures performed per patient. Rigid bronchoscopy with Nd:YAG laser and dilatation (mechanical or balloon) were the preferred methods used. Only 1(3.2%) patient was sent to surgery for re-stenosis after multiple interventional bronchoscopy treatments.</p> <p>Conclusion</p> <p>We have identified putative risk factors for the development of PI and PT stenosis. Differences in lesions characteristics and stenosis site were noted in our two patient groups. All patients underwent interventional bronchoscopy procedures as the first-line, and frequently the only treatment approach.</p

Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial:

IMPORTANCE: Therapeutic options for severe emphysema are limited. Lung volume reduction using nitinol coils is a bronchoscopic intervention inducing regional parenchymal volume reduction and restoring lung recoil. OBJECTIVE: To evaluate the efficacy, safety, cost, and cost-effectiveness of nitinol coils in treatment of severe emphysema. DESIGN, SETTING, AND PARTICIPANTS: Multicenter 1:1 randomized superiority trial comparing coils with usual care at 10 university hospitals in France. Enrollment of patients with emphysema occurred from March to October 2013, with 12-month follow-up (last follow-up, December 2014). INTERVENTIONS: Patients randomized to usual care (n = 50) received rehabilitation and bronchodilators with or without inhaled corticosteroids and oxygen; those randomized to bilateral coil treatment (n = 50) received usual care plus additional therapy in which approximately 10 coils per lobe were placed in 2 bilateral lobes in 2 procedures. MAIN OUTCOMES AND MEASURES: The primary outcome was improvement of at least 54 m in the 6-minute walk test at 6 months (1-sided hypothesis test). Secondary outcomes included changes at 6 and 12 months in the 6-minute walk test, lung function, quality of life as assessed by St George's Respiratory Questionnaire (range, 0-100; 0 being the best and 100 being the worst quality of life; minimal clinically important difference, ≥4), morbidity, mortality, total cost, and cost-effectiveness. RESULTS: Among 100 patients, 71 men and 29 women (mean age, 62 years) were included. At 6 months, improvement of at least 54 m was observed in 18 patients (36%) in the coil group and 9 patients (18%) in the usual care group, for a between-group difference of 18% (1-sided 95% CI, 4% to ∞; P = .03). Mean between-group differences at 6 and 12 months in the coil and usual care groups were +0.09 L (95% CI, 0.05 L to ∞) (P = .001) and +0.08 L (95% CI, 0.03 L to ∞) (P = .002) for forced expiratory volume in the first second, +21 m (95% CI, -4 m to ∞) (P = .06) and +21 m (95% CI, -5 m to ∞) (P = .12) for 6-minute walk distance, and -13.4 points (95% CI, -8 points to ∞) and -10.6 points (95% CI, -5.8 points to ∞) for St George's Respiratory Questionnaire (1-sided P < .001 for both). Within 12 months, 4 deaths occurred in the coil group and 3 in the usual care group. The mean total 1-year per-patient cost difference between groups was $47,908 (95$47,879-$48,073) (P < .001); the incremental cost-effectiveness ratio was$782,598 per additional quality-adjusted life-year. CONCLUSIONS AND RELEVANCE: In this preliminary study of patients with severe emphysema followed up for 6 months, bronchoscopic treatment with nitinol coils compared with usual care resulted in improved exercise capacity with high short-term costs. Further investigation is needed to assess durability of benefit and long-term cost implications. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01822795.Comment in : *Lung Volume Reduction Coils for Severe Emphysema--Reply. [JAMA. 2016] *Coils implanted into lungs show promise for emphysema. [BMJ. 2016] *Lung Volume Reduction Coils for Severe Emphysema. [JAMA. 2016] *Bronchoscopic Lung Volume Reduction in COPD: Lessons in Implementing Clinically Based Precision Medicine. [JAMA. 2016