Significant Improvement In FEV1 Research Articles

Bronchoscopic Lung Volume Reduction Procedures for Emphysema: A Network Meta-Analysis

Importance: Bronchoscopic lung volume reduction (BLVR) offers alternative novel treatments for patients with emphysema. Comprehensive evidence for comparing different BLVR remains unclear. Objective: To estimate the effects of different BLVR on patients with emphysema. DataSources: PubMed, EMBASE, Cochrane Library, and Web of Science databases from January 2001 to August 2017were searched. Study Selection: Randomized clinical trials (RCT) evaluated effects of BLVR on patients with emphysema. Data Extraction and Synthesis: The relevant information was extracted from the published reports with a predefined data extraction sheet, and the risk of bias was assessed with the Cochrane risk of bias tools. Main Outcomes and Measures: Pair-wise meta-analyses were made using the random-effects model. A random-effects network meta-analysis was applied within a Bayesian framework. The quality of evidence contributing to each network estimate was assessed using the GRADE framework. Results: 13 trials were deemed eligible, including 1993 participants. The quality of evidence was rated as moderate in most comparisons. Medical care (MC)was associated with the lowest adverse events compared with intra-bronchial valve (IBV)(-2.5,[-4.70 to -0.29]), endobronchial valve (EBV) (-1.73, [-2.37 to -1.09]), lung volume reduction coils (LVRC) (-0.76, [-1.24 to -0.28]), emphysematous lung sealant (ELS) (-1.53, [-2.66 to -0.39]), and airway bypass(-1.57, [-3.74 to 0.61]).Adverse events in LVRC were lower compared with ELS (-0.77,[-2.00 to 0.47]).Bronchoscopic thermal vapor ablation (BTVA) showed significant improvement inFEV1 compared with MC (0.99, [0.37 to 1.62]), IBV (1.25, [0.25 to 2.25]), and LVRC (0.72,[0.03 to 1.40]).6 MWT in ELS was significantly improved compared with other four BLVR, sham control, and MC (-1.96 to 1.99).Interestingly, MC showed less improvement in FEV1 and 6 MWT compared with EBV (-0.45, [-0.69 to -0.20] and -0.39, [-0.71 to -0.07], respectively).The mortality in MC and EBV was lower compared with LVRC alone (-0.38, [-1.16 to 0*41] and -0.50, [-1.68 to 0*68], respectively). BTVA and EBV led to significant changes in SGRQ compared with MC alone (-0.74, [-1.43 to -0.05] and 0.44, [0.11 to 0.78], respectively). Conclusions and Relevance: BLVR offered a clear advantage for patients with emphysema. EBV had noticeable beneficial effects on the improvement of FEV1, 6MWTand SGRQ, and was associated with lower mortality compared with MC in different strategies of BLVR. Funding: This project was supported by National major research program on Natural Science of China (91542164). Competing interests: The authors declare that they have no competing financial interests. Ethics Approval Statement: ??

To Evaluate the Outcome of Use of Inhalers in Patient with Chronic Obstructive Pulmonary Disease (COPD) Following Training

Background: Chronic obstructive pulmonary disease (COPD) is a common respiratory condition associated with high morbidity and mortality. A correct diagnosis of COPD can decrease symptoms, reduce frequency and severity of exacerbations, improve health status, improve exercise capacity, and prolong survival. Inhaler devices are mainstay in management of chronic obstructive pulmonary disease and their proper usage requires continuous training. A thorough literature search has shown limited data on the outcome of various techniques and devices used in COPD; hence this study is being done to study the outcome of use of inhalers in patients with COPD following training. Methods: This prospective, observational study was conducted on patients suffering from COPD as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The patients were given instructions and training correctly all patients were called after one month and spirometry parameters were assessed after one month. Spirometry and St. George Respiratory Questionnaire was administered to all participants. Results: A total of 60 patients were enrolled in study with the mean age of 49.37±17.65 years. 19 patient suffering from COPD also had concurrent diseases associated. Revolizer was used by 60% of patients. There was a significant (p<0.05) improvement in FEV1 and PEF after 1 month of proper use of inhalation technique. All patients showed a statistically significant (p<0.05) improvement in symptoms score in SGRQ. Conclusion: A significant improvement in FEV1, Ratio of FEV1/FVC and PEF was observed after 1 month, there was also improvement in Quality of life of patients.

Leukotriene receptor antagonists do not improve lung function decline in COPD: a meta-analysis.

Leukotriene receptor antagonists (LTRA), the anti-inflammatory agents, have been reported new therapeutic value in chronic obstructive pulmonary disease (COPD). However, the effects of LTRA on lung function decline in COPD were determined with inconsistent results and a meta-analysis is needed. Published cohort or randomized controlled studies were retrieved from PubMed and Embase databases. Pooled standardized mean difference (SMD) with 95% confidence interval (CI) was calculated in a random effects model. Six studies involving 221 COPD patients were included. Pooled effect size showed no significant improvements in FEV1 (SMD: 0.28, 95% CI: -0.17 to 0.72, p=0.227), FVC (SMD: 0.54, 95% CI: -0.10 to 1.18, p=0.597) and FEV1/FVC (SMD: 0.18, 95% CI: -0.09 to 0.46, p=0.189) in COPD patients after LTRA treatment. In subgroup analysis, neither short-term (<1 year) (SMD: 0.47, 95% CI: -0.06 to 0.99, p=0.082) nor long-term (≥1 year) (SMD: -0.13, 95% CI: -0.57 to 0.31, p=0.561) LTRA exposure could benefit lung function decline in COPD. This meta-analysis suggests neither short-term nor long-term exposure of LTRA can improve lung function decline in COPD. However, large scale randomized controlled trials are urgently warranted.

Bronchoscopic lung volume reduction with endobronchial valves for heterogeneous emphysema: long-term results.

Bronchoscopic lung volume reduction (BLVR) with implant of one-way endobronchial valves (EBV) is a feasible treatment for management of heterogeneous emphysema (HE) with clinical benefits in the early follow-up. We aimed to evaluate the long-terms results and safety of this procedure in a consecutive series of patients with HE. It was a retrospective single center study including all consecutive patients with HE undergoing EBV treatment and completing at least 5 years of long-term follow-up. Patients were splitted into Collapse and No-Collapse Group if a lobar collapse or not were obtained after valves implant. The difference of functional data and quality of life (QoL) before and after the procedure (measured at 3, 6, 9, 12 months from the valve implantation, and then annually up to a maximum of 5 years) were statistically evaluated to show the long-term benefits of the procedure (primary endpoint). Yet, morbidity, mortality and survival rates were also recorded to show the safe of the treatment (secondary endpoint). Thirty-three patients were included in the study. Of these, three patients underwent a bilateral treatment. Collapse Group patients (n=27) presented a significant improvement in FEV1% (+17%; P=0.001); in FVC% (+18%; P=0.002); in RV% (-39%; P=0.003); in 6MWT (P=0.001) and in SGRQ (P=0.001) in the early 12 months of follow-up and no significant decline was seen later. Conversely, No-Collapse Group (n=9) did not have significant benefits. No major complications and death related to the procedure were observed. The 1-,2-,3-,4- and 5-year survival rates were 100%, 90%, 78%, 71% and 71%, respectively. Collapse Group had a better survival than No-Collapse Group (45 vs. 24 months; P=0.001). Our study confirmed that the lobar collapse is the key success of EBV treatment and the early improvements of respiratory function could be maintained up to five years from the valves implant.

CORK Study in Cystic Fibrosis: Sustained Improvements in Ultra-Low-Dose Chest CT Scores After CFTR Modulation With Ivacaftor

Ivacaftor produces significant clinical benefit in patients with cystic fibrosis (CF) with the G551D mutation. Prevalence of this mutation at the Cork CF Centre is 23%. This study assessed the impact of cystic fibrosis transmembrane conductance regulator modulation on multiple modalities of patient assessment. Thirty-three patients with the G551D mutation were assessed at baseline and prospectively every 3months for 1 year after initiation of ivacaftor. Change in ultra-low-dose chest CT scans, blood inflammatory mediators, and the sputum microbiome were assessed. Significant improvements in FEV1, BMI, and sweat chloride levels were observed post-ivacaftor treatment. Improvement in ultra-low-dose CT imaging scores were observed after treatment, with significant mean reductions in total Bhalla score (P< .01), peribronchial thickening (P= .035), and extent of mucous plugging (P< .001). Reductions in circulating inflammatory markers, including interleukin (IL)-1β, IL-6, and IL-8 were demonstrated. There was a 30%reduction in the relative abundance of Pseudomonas species and an increase in the relative abundance of bacteria associated with more stable community structures. Posttreatment community richness increased significantly (P= .03). Early and sustained improvements on ultra-low-dose CT scores suggest it may be a useful method of evaluating treatment response. It paralleled improvement in symptoms, circulating inflammatory markers, and changes in the lung microbiota.

A comparison of two endoscopic posterior cordotomy techniques: Laser cordotomy vs diathermy-assisted cordotomy.

To compare respiratory function, swallowing and voice quality of bilateral abductor vocal fold paralysis (BAVFP) patients undergoing laser and diathermy-assisted posterior cordotomy. Prospective study. Tertiary academic hospital. Thirty patients were included in the study (groups 1 and 2, 15 patients each). Mean age was 53 ± 14.27 years with a range of 31-78 years (12 [40%] males, 18 [60%] females). Sufficient airway, complications, FEV1, FEV1/FVC, peak expiratory flow rate (PEF), voice quality VAS, fundamental frequency, jitter, shimmer, NHR, amplitude perturbation quotient (APQ) and pitch perturbation quotient (PPQ) scores. A sufficient laryngeal airway was achieved in all patients. Six patients (20%) developed postoperative granulation tissue (2 in group 1 and 4 in group 2). There was a statistically significant improvement in FEV1, FEV1/FVC and PEF measurements at the postoperative sixth month compared to preoperative measurements in both of the groups (P < .05). Preoperative median voice quality VAS scores in groups 1 and 2 were 8 (IQR = 1) and 8 (IQR = 3), respectively. Postoperative sixth-month voice quality VAS scores in groups 1 and 2 were 6 (IQR = 1) and 6 (IQR = 0), respectively. Postoperative VAS scores were significantly lower in both groups (P < .05). The postoperative changes in fundamental frequency, NHR, jitter, shimmer, APQ and PPQ were not statistically significant in both of the groups (P > .05). Laser and diathermy-assisted posterior cordotomy are both minimally invasive, effective techniques with a long-term sufficient laryngeal airway. Despite lower quality of voice VAS scores, objective acoustic outcomes were not significantly lower in both of the groups.

Effect of allergic phenotype on treatment response to inhaled bronchodilators with or without inhaled corticosteroids in patients with COPD.

BackgroundChronic obstructive pulmonary disease (COPD) is a heterogeneous disorder encompassing different phenotypes with different responses to treatment. The present 1-year, two-center hospital-based study investigated whether the plasma immunoglobulin E (IgE) level and/or eosinophil cell count could be used as biomarkers to stratify patients with COPD according to predicted responses to inhaled corticosteroids (ICS)-based therapy.MethodsA hospital-data based cohort study of COPD patients treated at two territory hospital centers was conducted for 1 year. Allergic biomarkers, including blood eosinophil counts and IgE levels, were assessed at baseline. Lung function parameters, including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and the COPD Assessment Test (CAT), were also evaluated. The frequencies of acute exacerbation (AE) and pneumonia were also measured. Eosinophilia and a high IgE level were defined as >3% and 173 IU/mL, respectively.ResultsA total of 304 patients were included. Among patients with eosinophilia and high IgE levels, ICS-based therapy was associated with significant improvements in FEV1, FVC, and CAT scores, compared with bronchodilator (BD) therapy (P≤0.042). ICS-based therapy was also associated with a significantly lower incidence of AE vs BD-based therapy (11.7% vs 24.1%; P<0.008). Among patients with only eosinophilia, ICS-based therapy yielded significantly better CAT score results vs BD-based treatment (7 vs 13; P=0.032). A receiver operating characteristic curve analysis found that the combination of a high plasma IgE level and eosinophilia most sensitively and specifically identified patients who would benefit from the addition of ICS to BD therapy.ConclusionOur findings support the use of blood eosinophil cell counts plus IgE levels as predictive biomarkers of the ICS response in certain patients with COPD. Both biomarkers could potentially be used to stratify COPD patients regarding ICS-based therapy.

Acu-tens improves lung function in patients with chronic bronchial asthma: a randomized placebo-controlled trial

Context Bronchial asthma greatly affects patient’s quality of life. Application of transcutaneous electrical nerve stimulation on acupuncture is a promising noninvasive modality that may assist in controlling dyspnoea and improving lung function in those patients. Aims This study investigated the effect of Acu-TENS on lung function [forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC)] and the modified medical research council dyspnoea scale. Settings and design This study was conducted as a double-blind randomized controlled trial among 40 male patients diagnosed with moderate chronic bronchial asthma selected from Elmenia University Hospitals. Patients and methods Their ages ranged from 35 to 45 years with a mean value of 41.45±2.74 years. They were assigned randomly to two equal groups: the experimental (Acu-TENS) group, which received 45 min of Acu-TENS on bilateral Dingchuan acupoints three sessions/week for 4 weeks, and the control (placebo-TENS) group, which received 45 min of placebo-TENS 3 sessions/week for 4 weeks. Lung function was measured as FEV1 and FVC using a portable spirometer. Dyspnoea was measured using the modified medical research council dyspnoea scale. Assessment was carried out before and after 1 month of treatment. Results The results revealed that after treatment there was a significant improvement in FEV1, which increased by 15.08%, and FVC, which increased by 13.18%, in favour of the Acu-TENS group when compared with the control group (P=0.037 and 0.016 for FEV1 and FVC, respectively). However, there was no significant difference in the modified medical research council dyspnoea scale between the Acu-TENS group and the placebo-TENS group after treatment (P=0.343). Conclusion It was concluded that Acu-TENS on bilateral Ding Chuan acupoints for 4 weeks is an effective approach for improving lung function (FEV1 and FVC).

Bronchodilator activity of Ocimum sanctum Linn. (tulsi) in mild and moderate asthmatic patients in comparison with salbutamol: a single-blind cross-over study

Background: Bronchial asthma is one of the commonest chronic inflammatory diseases. The drugs available to treat bronchial asthma such as, beta-2 agonists, though very effective are associated with adverse effects. Therefore, the Ocimum sanctum (Tulsi) which was shown to have antiasthmatic activity in Ayurveda, is evaluated in this study.Objectives: To evaluate the bronchodilator activity of Ocimum sanctum Linn. in mild and moderate asthma and compare its efficacy with the standard bronchodilator drug, Salbutamol.Methods: This is a single-blind cross-over study. Capsules of Ocimum sanctum Linn. (200 mg, twice daily) and Salbutamol sulphate (2 mg, twice daily) were administered in 41 patients. Each drug was administered for a period of one week with a washout period of one week between the two drug schedules. FEV1 and PEFR were recorded in these patients to assess the bronchodilator activity before the drug administration, on 4th and on 7th day of administration of Ocimum sanctum and the parameters obtained were compared with that of the standard drug, Salbutamol.Results: Ocimum sanctum 200mg twice daily produced significant improvement in both FEV1 and PEFR values, on 4th and 7th day and also produced improvement in symptoms of asthma. On comparing the results with that of Salbutamol 2mg twice daily, the bronchodilator activity of Ocimum sanctum was found to be less efficacious, where Salbutamol produced very highly significant improvement in FEV1 and PEFR values on both 4th and 7th day.Conclusions: Our results suggest that Ocimum sanctum Linn. possesses significant bronchodilator activity in mild and moderate bronchial asthma.

Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary disease.

Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary disease.

Mometasone furoate (MF) improves lung function in pediatric asthma: A double-blind, randomized controlled dose-ranging trial of MF metered-dose inhaler.

Mometasone furoate (MF), delivered via dry-powder inhaler (DPI) QD in the evening (PM), is a treatment option for pediatric patients with asthma. We evaluated MF delivered via a metered-dose inhaler (MDI), in children ages 5-11 years with persistent asthma. This was a 12-week double-blind, double-dummy, placebo-controlled trial. Pateints were randomized to the following treatments: MF-MDI 50 mcg BID, MF-MDI 100 mcg BID, MF-MDI 200 mcg BID, MF-DPI 100 mcg QD PM, and placebo. The primary analysis assessed MF-MDI doses versus placebo, on the change in %-predicted forced expiratory volume in one second (FEV1 ) from baseline to week-12; a secondary analysis compared MF-MDI 50 mcg BID versus MF-DPI 100 mcg QD PM. Adverse events (AEs) were monitored throughout the trial. For change from baseline in %-predicted FEV1 at week 12, least-squares (LS) mean differences from placebo were 3.87 (P = 0.019), 6.29 (P < 0.001), and 5.34 (P = 0.001) percentage-points for MF-MDI 50, 100, and 200 mcg BID, respectively. The LS mean difference for MF-MDI 50 mcg BID versus MF-DPI 100 mcg QD PM was 1.39 (P = 0.368). AE incidences were similar among all treatment groups. There were no reports of oropharyngeal candidiasis or dysphonia, which were AEs pre-specified for analysis,. In children ages 5-11 years with persistent asthma, all three doses of MF-MDI (50, 100, and 200 mcg BID) demonstrated significant improvement in FEV1 after 12 weeks of treatment. MF was generally well tolerated with no new safety concerns identified in this trial. Pediatr Pulmonol. 2017;52:310-318. © 2016 Wiley Periodicals, Inc.

Continuous alternating inhaled antibiotic therapy in CF: A single center retrospective analysis

IntroductionThe efficacy of inhaled antibiotics to treat chronic Pseudomonas aeruginosa pulmonary infection in patients with cystic fibrosis (CF) has been well established. Few data are available on the value of continuous alternating inhaled antibiotic therapy (CAIT), a strategy increasingly used in the management of CF. ObjectiveTo investigate the effect of CAIT on clinical outcome in adult CF patients treated at the University Hospital Leuven. MethodsPatients with a documented CF diagnosis who received inhaled antibiotics between March 2010 and January 2015 were retrospectively evaluated. In patients receiving CAIT patient characteristics, recorded spirometry data and number of IV antibiotic days were collected retrospectively at fixed time intervals, from 6months before to one year after the start of the 2nd inhaled antibiotic. For patients on inhaled antibiotic monotherapy (IAMT), the same data were obtained at similar intervals during the study period. ResultsA total of 49 of 89 patients using chronic inhaled antibiotic therapy received CAIT. Patients receiving CAIT had a lower baseline FEV1 and were more likely to be homozygous for F508del compared to patients receiving IAMT. FEV1 deteriorated on average by a factor of 0.904 per year (95% CI: 0.851–0.960) prior to the start of CAIT. The initiation of CAIT was associated with an average improvement in FEV1 by a factor of 1.148 per year (95% CI: 1.068–1.236, p=0.0002). The analysis of specific types of antibiotics revealed evidence of positive effects of adding COLI to TOBI and COLI to AZLI. We found no effect of the initiation of CAIT on the number of IV antibiotic days (p=0.80). ConclusionCF patients with more advanced lung disease are more likely to receive CAIT. In this patient group, CAIT was associated with a significant improvement in FEV1. Further data are warranted to identify the value of CAIT.

Anti-interleukin 5 Therapy for Eosinophilic Asthma: a Meta-analysis of Randomized Clinical Trials.

Recently, more and more clinical trials have been performed to evaluate the effects of anti-interleukin (IL)-5 antibodies in eosinophilic asthma. However, a confirm conclusion has not been well established. We therefore sought to conduct a meta-analysis to assess the overall efficacy and safety of anti-interleukin 5 treatments in eosinophilic asthma. RCTs of anti-interleukin 5 treatments in eosinophilic asthma published up to June 2016 in PubMed, Embase, Cochrane library databases, and CBM, which reported pulmonary functions, quality-of-life scores, asthmatic exacerbations, and adverse events were included. Fixed-effect models were used to calculate mean difference, relative risks (RR), and 95% CIs. Twelve studies involving 3340 patients were identified. Pooled analysis revealed significant improvements in FEV1 (nine trials, 1935 subjects; MD = 0.12; 95% CI, 0.08-0.16), and Asthma Quality-of-Life Questionnaire scores (five trials, 1334 subjects; MD = 0.23; 95% CI, 0.13-0.34). Anti-interleukin 5 treatment was also associated with significantly decreased exacerbation risk than placebo (six trials, 875 subjects; RR = 0.52; 95% CI, 0.46 to 0.59) and a lower incidence of adverse events (eight trials, 1754 subjects; RR = 0.93; 95% CI, 0.89 to 0.97). Anti-interleukin 5 treatment is well tolerated and could significantly improve FEV1, quality of life, and reduced exacerbations risk in patients with eosinophilic asthma. Further trials are necessary to assess the baseline blood eosinophil count to identify the optimal patients of eosinophilic asthma that could benefit from anti-interleukin 5 therapy.

The effect of α1-antitrypsin deficiency combined with increased bacterial loads on chronic obstructive pulmonary disease pharmacotherapy: A prospective, parallel, controlled pilot study

Chronic obstructive pulmonary disease (COPD) is caused by α1-antitrypsin deficiency (AATD) genetic susceptibility and exacerbated by infection. The current pilot study aimed at studying the combined effect of AATD and bacterial loads on the efficacy of COPD conventional pharmacotherapy. Fifty-nine subjects (29 controls and 30 COPD patients) were tested for genetic AATD and respiratory function. The bacterial loads were determined to the patients’ group who were then given a long acting beta-agonist and corticosteroid inhaler for 6months. Nineteen percent of the studied group were Pi∗MZ (heterozygote deficiency variant), Pi∗S (5%) (milder deficiency variant), Pi∗ZZ (10%) (the most common deficiency variant), and Pi∗Mmalton (2%) (very rare deficiency variant). The patients’ sputum contained from 0 to 8×108CFU/mL pathogenic bacteria. The forced vital capacity (FVC6) values of the AAT non-deficient group significantly improved after 3 and 6months. Patients lacking AATD and pathogenic bacteria showed significant improvement in forced expiratory volume (FEV1), FEV1/FVC6, FVC6, and 6min walk distance (6MWD) after 6months. However, patients with AATD and pathogenic bacteria showed only significant improvement in FEV1 and FEV1/FVC6. The findings of this pilot study highlight for the first time the role of the combined AATD and pathogenic bacterial loads on the efficacy of COPD treatment.

Phase 3 Study of Reslizumab in Patients With Poorly Controlled Asthma: Effects Across a Broad Range of Eosinophil Counts

IL-5, a mediator of eosinophil activity, is an important potential treatment target in patients with uncontrolled asthma. The efficacy of reslizumab, a humanized anti-human IL-5 monoclonal antibody, has been characterized in patients withblood eosinophils≥ 400 cells/μL. This study further characterizes the efficacy and safetyof reslizumabin patients with poorly-controlled asthma, particularly those with eosinophils <400 cells/μL. Patients were randomly assigned to intravenous reslizumab 3.0mg/kg or placebo once every 4weeks for 16weeks. The primary end point was the change in FEV1 from baseline to week 16. Secondary measures included Asthma Control Questionnaire-7 (ACQ-7) scores, use of short-acting β-agonists (SABAs), and FVC. Four hundred ninety-two patients received≥ 1 dose of placebo (n= 97) or reslizumab (n= 395). In the overall population, mean FEV1 change from baseline to week 16 was not significantly different between reslizumab and placebo, and no significant relationship was detected between treatment, baseline blood eosinophils and change in FEV1. In the subgroup of patients with baseline eosinophils< 400 cells/μL, patients treated with reslizumab showed no significant improvement in FEV1 compared with those receiving placebo. In the subgroup with eosinophils≥ 400 cells/μL, however, treatment with reslizumab was associated with much larger improvements in FEV1, ACQ-7, rescue SABA use, and FVC compared with the placebo group. Reslizumab was well tolerated, with fewer overall adverse events compared with placebo (55%vs73%). Reslizumab was well tolerated in patients with inadequately controlled asthma. Clinically meaningful effects on lung function and symptom control were not seen in patients unselected for baseline eosinophils. ClinicalTrials.gov; No.: NCT01508936; URL: www.clinicaltrials.gov.

The role of a multidisciplinary student team in the community management of chronic obstructive pulmonary disease.

To determine whether a community-based, multidisciplinary team consisting of home-based caregivers and supervised students could improve the functional status and quality of life of patients living with chronic obstructive pulmonary disease (COPD) in a low-income, peri-urban setting in South Africa. This was a quasi-experimental study conducted over three months. Attention was paid to health literacy, inhaler technique, respiratory conditioning and nutrition. Health literacy was poor and most patients were not using their inhalers correctly. Five of 12 patients found exercising challenging and withdrew from the study early. In the remaining seven patients, statistically significant improvements in FEV1%, and quality of life scores were seen at three months. Improvements in exercise tolerance and BODE prognostic index did not reach statistical significance. A home-based multidisciplinary student team can improve the functional status and the quality of life in patients living with COPD in a low-income setting. This approach offers a suitable model for community-based service learning.

Once daily nebulized beclomethasone is effective in maintaining pulmonary function and improving symptoms in asthmatic children

Compliance with long-term inhaled therapy in asthma is often poor, but it is likely to be improved with a simplified administration, once daily. The present study was designed to assess whether, in childhood asthma, a single dose of nebulized beclomethasone dipropionate once daily was as effective and safe as the same total daily dose administered twice daily. Asthmatic children, not treated with inhaled steroids for at least a month preceding the study and using short-acting bronchodilators more than once a week were enrolled in a double-blind, double dummy, randomised, multicentric study. After a two week run-in period on nebulised twice daily 400 mcg beclomethasone dipropionate, patients were randomly assigned to twelve weeks of treatment with 800 mcg nebulised beclomethasone dipropionate daily, either in single dose (o.d. group) or divided into two 400 mcg doses (b.i.d. group). 65 children (mean age 8.6 years, mean FEV1 81% of predicted), were valuable for intention to treat. During the run-in period, a significant improvement in FEV1, FVC, morning and evening PEF values and clinical scores was observed. Children then entered the randomised trial: 32 were included in the o.d. group and 33 in the b.i.d. group. During the twelve week treatment period, the observed improvement in pulmonary function parameters was maintained in both treatment groups. Morning and evening PEF showed a progressive slight increase as well as PEF diurnal variability showed a progressive reduction in the two treatment groups during the whole study period without reaching statistical significance. Moreover, in both treatment groups a similar progressive increase in symptom free nights and days and in the percentage of children achieving total asthma symptoms control was detected. Finally, no significant changes in urinary cortisol/creatinine ratio were observed throughout the study period and between groups. A daily dose of 800 mcg of beclomethasone, administered for twelve weeks with a nebuliser either once or twice daily provide similar efficacy in maintaining pulmonary function and symptoms of asthmatic children, with a good tolerability profile.

Pulmonary Function and Rescue Medication Use in Patients Receiving Omalizumab in Real World Settings: A Systematic Literature Review of Nonrandomized Studies

SESSION TITLE: Allergy and Airway Posters SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM PURPOSE: The objective was to provide a summary of the real-world clinical and health economic outcomes associated with omalizumab in the treatment of moderate to severe allergic asthma. METHODS: A systematic literature review was conducted to identify studies of omalizumab in patients ≥12 years with moderate to severe allergic asthma. A search of MEDLINE and EMBASE reference databases was conducted for relevant studies published from 2003 to 2014. Outcomes of interest included rescue medication use and pulmonary function assessments (FEV1, FVC, and PEF). Patient-reported outcomes (PROs) were also reviewed for included studies. Study quality was assessed by 2 reviewers using the Newcastle-Ottawa Quality Assessment Scale of Cohort Studies and the International Society of Pharmacoeconomics and Outcomes Research checklist. RESULTS: A total of 42 studies were included; 20 studies evaluated pulmonary function and 9 evaluated rescue beta-agonist use. Statistically significant improvements in FEV1 were reported in 75% (15/20) of included studies. Improvements in FEV1 ranged from 3.2%-43.6%. Five studies reported changes in FVC or FEV1/FVC. Significant improvements in FVC were observed in 3 studies and in FEV1/FVC in 2 studies. Six studies analyzed PEF with 5 finding significant improvements. Seven studies reported significant reductions in rescue medication use. The percentage of patients with any rescue medication use ranged from 87.0%-97.7% at baseline to 12.5%-49.8% at follow-up. In studies examining change in use from baseline, change at follow-up ranged from 56.1%-78.8%. Among the included studies, 14 utilized patient-reported health-related quality of life (HRQoL) outcomes. The ACT (12 studies) and the AQLQ (4 studies) were the most commonly used surveys to assess asthma control and HRQoL, and improvements were consistently seen after omalizumab was added to therapy. CONCLUSIONS: While patient populations and outcome definitions are heterogeneous, overall, patients with moderate to severe asthma using omalizumab had improvements in FEV1 and PEF and experienced a decrease in the need for rescue beta-agonist medications. Patient-reported asthma control and HRQoL appears to improve among patients utilizing omalizumab in clinical settings. CLINICAL IMPLICATIONS: Asthma patients administered omalizumab during routine clinical use experience significant clinical benefits, including an improvement in pulmonary function and decrease in rescue medication usage. DISCLOSURE: Jonathan Corren: Consultant fee, speaker bureau, advisory committee, etc.: Consultant to Novartis Susan Gabriel: Employee: Novartis Employee Tom Karagiannis: Employee: Novartis employee Kimberly Ruiz: Consultant fee, speaker bureau, advisory committee, etc.: Consultant to Novartis Bethany Sawchyn: Consultant fee, speaker bureau, advisory committee, etc.: Consultant to Novartis Jennifer Colby: Consultant fee, speaker bureau, advisory committee, etc.: Consultant to Novartis Meryl Mendelson: Employee: Novartis employee No Product/Research Disclosure Information

Lung Volume Reduction Following Recurrent Pneumonia; Unusual Finding in a COPD Patient

SESSION TITLE: Obstructive Lung Disease Case Report Posters SESSION TYPE: Affiliate Case Report Poster PRESENTED ON: Tuesday, October 27, 2015 at 01:30 PM - 02:30 PM INTRODUCTION: COPD is a slowly progressive disease and frequent pneumonias are known to accelerate progression. We present an unusual case of a patient with severe emphysema whose FEV1, lung volumes and gas exchange improved following recurrent pneumonia, without lung volume reduction surgery. CASE PRESENTATION: A 54 years-old female with severe air-flow obstruction and marked air-trapping was evaluated at our institution in April 2007 for LVRS, but was deemed not a candidate because of a homogeneous distribution of her emphysema. Two-months after evaluation she developed pseudomonas pneumonia with extensive involvement of her right lung. Her course was complicated by prolonged respiratory failure requiring tracheostomy and pneumothorax with prolonged air-leak. The patient was discharged after 2-month hospital stay and had gradual improvement in her respiratory status over 3-years, despite three additional hospital admissions for pneumonia over that time period. In December 2009 she had repeat pulmonary function studies performed which showed a dramatic improvement in her FEV1, lung volumes and arterial blood gases(Table1).By March 2010 she was able to be weaned off of oxygen. Her imaging studies showed fibrotic changes and decreased lung volume compared to her baseline studies which demonstrated marked hyperinflation and diaphragm flattening(Fig.1). DISCUSSION: Evidence suggests that COPD exacerbations are associated with an excess decline in FEV1. However our patient showed significant improvement in FEV1 and oxygenation over time despite repeated pneumonia. These findings are likely due to fibrotic changes and a decrease in hyperinflation as a result of scarring and remodeling following recurrent infection. It is known that LVRS improves spirometry, lung volumes and symptoms. However it is major surgery associated with significant morbidity. There has been a continued effort to develop safe and effective non-surgical techniques. In recent years, evidence suggests that biologic lung reduction may be a feasible and safe technique. This case supports the concept that biologic agents can potentially reduce lung volumes by triggering structural changes. CONCLUSIONS: This case demonstrates improved lung function following recurrent pneumonia in a patient with severe emphysema. We believe this example provides important insight for the continued search of effective non-surgical LVR methods. Reference #1: Vestbo J et al. N Engl J Med 2011;365:1184-92. Reference #2: Fishman A et al. N Engl J Med 2003;348(21):2059. Reference #3: Refaely Y et al. Eur Respir J.2010;36(1):20. DISCLOSURE: The following authors have nothing to disclose: Yihenew Negatu, Philip Diaz No Product/Research Disclosure Information

Efficacy and tolerability of budesonide/formoterol added to tiotropium compared with tiotropium alone in patients with severe or very severe COPD: A randomized, multicentre study in East Asia.

Triple combination therapy with tiotropium plus budesonide/formoterol has improved lung function and reduced exacerbation risk in patients with chronic obstructive pulmonary disease (COPD) in Western countries, but no such data exist for East Asian patients. This study aimed to evaluate the efficacy and tolerability of adding budesonide/formoterol to tiotropium compared with tiotropium alone in East Asian patients with severe/very severe COPD. This 12-week, randomized, parallel-group, multicentre, open-label study was conducted in East Asia. After a 14-day run-in period during which patients received tiotropium 18 μg once daily, patients were randomized to tiotropium (18 μg once daily) + budesonide/formoterol (160/4.5 μg 2 inhalations twice daily) or tiotropium alone (18 μg once daily). The primary endpoint was change from baseline in pre-dose forced expiratory volume in 1 s (FEV1 ) to the mean of values measured at Weeks 1, 6 and 12. Pre-dose FEV1 significantly increased from baseline with tiotropium plus budesonide/formoterol (n = 287) versus tiotropium alone (n = 291) (5.0% vs 0.6%; treatment difference: 4.4% (95% CI: 1.9-6.9), P = 0.0004). Triple therapy also reduced the COPD exacerbation rate by 40.7% (P = 0.0032) and prolonged time to first exacerbation (38.6% risk reduction, P = 0.0167) versus tiotropium alone and markedly improved health-related quality of life (HRQoL), measured using the St George's Respiratory Questionnaire. Incidence of adverse events was 26% for both groups. In East Asian patients with severe/very severe COPD, adding budesonide/formoterol to tiotropium was associated with significant improvements in FEV1 and HRQoL and lower COPD exacerbation rates. Treatment was generally well tolerated. NCT01397890 at Clinicaltrials.gov.