scholarly journals Impact of pre-enrolment medication use on clinical outcomes in SUMMIT

2019 ◽  
Vol 5 (1) ◽  
pp. 00203-2018 ◽  
Author(s):  
Jørgen Vestbo ◽  
Mark Dransfield ◽  
Julie A. Anderson ◽  
Robert D. Brook ◽  
Peter M.A. Calverley ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Inhaled Corticosteroids ◽  
Controlled Trial ◽  
Prior Treatment ◽  
Study Entry ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Mortality And Morbidity ◽  
Randomised Study ◽  
The Impact

The impact of prior treatment on results of clinical trials in chronic obstructive pulmonary disease (COPD) has been debated. We used data from the Study to Understand Mortality and Morbidity in COPD Trial to examine the impact of prior treatment on the effects of randomised study drugs on mortality and exacerbations.We used data on 16 417 patients with moderate COPD and heightened cardiovascular risk and information on prior medications to examine the effects of fluticasone furoate (FF), vilanterol (VI) and combined FF/VI compared to placebo on moderate and severe exacerbation as well as mortality. The study was event-driven with a median study exposure of 1.8 years. This study was registered with ClinicalTrials.gov, number NCT01313676.There were no consistent associations between treatment prior to study entry and the effects of FF, VI or FF/VI on exacerbations during the study. However, patients taking inhaled corticosteroids and one or more bronchodilators prior to study entry seemed to have a better effect of active treatments than of placebo on mortality (hazard ratio for FF/VI 0.65, 95% CI 0.48–0.89). Survival in those randomised to placebo was independent of treatment prior to study enrolment.Prior treatment appears to affect treatment effects on mortality but not exacerbations in a randomised controlled trial of patients with COPD and heightened cardiovascular risk.

scholarly journals A Systematic Review of Risk Factors Associated with Near-Fatal and Fatal Asthma

2005 ◽  
Vol 12 (5) ◽  
pp. 265-270 ◽  
Author(s):  
GG Alvarez ◽  
M Schulzer ◽  
D Jung ◽  
JM FitzGerald
Keyword(s):  
Risk Factors ◽  
Mechanical Ventilation ◽  
Inhaled Corticosteroids ◽  
Respiratory Arrest ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Mortality And Morbidity ◽  
Factors Associated ◽  
Fatal Asthma ◽  
The Impact

BACKGROUND: Asthma mortality and morbidity continue to be a serious global problem. Systematic reviews provide an opportunity to review risk factors in detail.OBJECTIVE: To review all of the literature for risk factors associated with near-fatal asthma (NFA) and fatal asthma (FA).METHODS: A literature search from 1960 to January 2004 in MEDLINE and EMBASE was conducted. Studies were included based on the following criteria: NFA was defined as an asthma exacerbation resulting in respiratory arrest requiring mechanical ventilation or a partial pressure of CO2of at least 45 mmHg or asthma resulting in death (FA); the study reported the number of cases (NFA and/or FA) and asthmatic controls; there was explicit reporting of risk factors; cases that were adult and pediatric in nature; and all study types. Studies that included patients with chronic obstructive pulmonary disease were excluded.RESULTS: Four hundred and three articles were identified, of which 27 met the inclusion criteria. Increased use of medications such as beta-agonists via metered dose inhalers (OR=1.67, 95% CI 0.99 to 2.84, P=0.057) and nebulizers (OR=2.45, 95% CI 1.52 to 3.93, P=0.0002), oral steroids (OR=2.71, 95% CI 1.34 to 5.51, P=0.006) and oral theophylline (OR=2.02, 95% CI 1.03 to 3.98, P=0.04) and a history of hospital (OR=2.62, 95% CI 1.04 to 6.58, P=0.04) and/or intensive care unit (OR=5.14, 95% CI 1.91 to 13.86, P=0.001) admissions and mechanical ventilation (OR=6.69, 95% CI 2.80 to 15.97, P=0.0001) due to asthma were predictors of NFA and FA. Prior emergency department assessment did not confer a greater risk of NFA and FA (OR=1.13, 95% CI 0.43 to 2.92, P=0.810).The use of inhaled corticosteroids (ICS) measured in a dose-independent fashion (did the patient take ICS previously; yes or no) inferred equivocal risk of NFA and FA (OR=1.31, 95% CI 0.83 to 2.05, P=0.25). However, two studies measured the use of ICS in a dose-dependent fashion (ie, measured the number of prescriptions filled within the previous six to 12 months). Both studies showed a trend toward a protective effect against FA. One study showed that the premature cessation of ICS can hasten death.CONCLUSIONS: In the present study, risk factors of NFA and FA have been more accurately defined. Clinicians should identify patients with these characteristics to reduce their risk of NFA and FA. Further research should focus on quantifying the impact of risk factors on asthma deaths.

scholarly journals A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol

2016 ◽  
Vol 48 (2) ◽  
pp. 320-330 ◽  
Author(s):  
Steven J. Pascoe ◽  
David A. Lipson ◽  
Nicholas Locantore ◽  
Helen Barnacle ◽  
Noushin Brealey ◽  
...  
Keyword(s):  
Treatment Period ◽  
Inhaled Corticosteroids ◽  
Controlled Trial ◽  
Phase Iii ◽  
Chronic Obstructive ◽  
Impact Study ◽  
Double Blind ◽  
Link Type ◽  
Long Acting ◽  
The Impact

Patients with symptomatic advanced chronic obstructive pulmonary disease (COPD) who experience recurrent exacerbations are particularly at risk of poor outcomes and present a significant burden on healthcare systems. The relative merits of treating with different inhaled combination therapies e.g. inhaled corticosteroids (ICS)/long-acting β2-agonist (LABA), LABA/long-acting muscarinic antagonists (LAMA), ICS/LABA/LAMA, in this patient group are poorly understood, as is reflected in current guidelines. The InforMing the PAthway of COPD Treatment (IMPACT) study will evaluate the efficacy and safety of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus FF/VI or UMEC/VI over a 52-week treatment period. The study has been designed with a focus on understanding the comparative merits of each treatment modality in different phenotypes/endotypes.This is a phase III, randomised, double-blind, three-arm, parallel-group, global multicentre study comparing the rate of moderate and severe exacerbations between FF/UMEC/VI and FF/VI or UMEC/VI over a 52-week treatment period. The study aims to recruit 10 000 patients from approximately 1070 centres. Eligible patients are aged ≥40 years, with symptomatic advanced COPD (Global initiative for chronic Obstructive Lung Disease (GOLD) group D) and an exacerbation in the previous 12 months.The first patients were recruited to the IMPACT study (ClinicalTrials.gov: NCT02164513) in June 2014 and the anticipated completion date is July 2017.

scholarly journals Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI and UMEC/VI in Patients with COPD: Subgroup Analysis of the China Cohort in the IMPACT Trial

2019 ◽  
Author(s):  
Jinping Zheng ◽  
Nanshan Zhong ◽  
Changzheng Wang ◽  
Li Ping Wei ◽  
Xiang Dong Zhou ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Dual Therapy ◽  
Multicenter Trial ◽  
Forced Expiratory Volume ◽  
Phase Iii ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Double Blind ◽  
Treatment Difference ◽  
The Impact

Abstract Background In the Phase III InforMing the PAthway of COPD Treatment (IMPACT) trial, fluticasone furoate [FF]/umeclidinium [UMEC]/vilanterol [VI] single-inhaler triple therapy resulted in lower rates of moderate/severe exacerbations than dual therapy with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Here we present the result in the subpopulation of patients enrolled in China. Methods The IMPACT trial was a 52-week, randomized, double-blind, parallel-group, multicenter trial. Patients (≥40 years of age) with COPD and ≥1 moderate/severe exacerbations in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg, or UMEC/VI 62.5/25 µg administered via the Ellipta inhaler. Endpoints, assessed in the overall intent-to-treat (ITT) population and in patients from China, included annual rates of exacerbations, time-to-first on-treatment moderate/severe exacerbation, and change from baseline in trough forced expiratory volume in 1 second (FEV1) at Week 52. Results Of the 10,355 patients randomized, 535 (5.2%) were from China. In the China cohort, the rate of on-treatment moderate/severe exacerbations was 0.81 per year with FF/UMEC/VI versus 0.96 with FF/VI (rate ratio [RR]: 0.84; 95% confidence interval [CI]: 0.64, 1.11; p=0.227) and 0.80 with UMEC/VI (RR: 1.02; 95% CI: 0.72, 1.44; p=0.929). Hazard ratio for time-to-first moderate/severe exacerbation was 0.84 (95% CI: 0.63, 1.11; p=0.218) for FF/UMEC/VI versus FF/VI, and 0.89 (95% CI: 0.62, 1.27; p=0.516) for FF/UMEC/VI versus UMEC/VI. Improvements in mean change from baseline in trough FEV1 were observed for FF/UMEC/VI versus FF/VI (treatment difference 137 mL; 95% CI: 86, 188; p<0.001) and FF/UMEC/VI versus UMEC/VI (treatment difference 63 mL; 95% CI: 0, 125; p=0.0.050) in China. Health status was also improved with FF/UMEC/VI versus both dual therapies. Broadly, these results were in the same direction as those seen in the overall ITT population. No new safety signals were identified. Conclusions In the China cohort of the IMPACT trial, single-inhaler triple therapy with FF/UMEC/VI versus dual therapy with FF/VI or UMEC/VI reduced the rate and risk of exacerbations, and improved lung function and quality of life similar to the overall ITT population. Trial registration: NCT02164513 (GSK study number CTT116855).

scholarly journals Management of chronic obstructive pulmonary disease: A review focusing on exacerbations

2020 ◽  
Vol 77 (4) ◽  
pp. 259-268
Author(s):  
Suzanne G Bollmeier ◽  
Aaron P Hartmann
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Patient Education ◽  
Disease Management ◽  
Pulmonary Disease ◽  
The United States ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Obstructive Pulmonary Disease ◽  
Copd Exacerbations ◽  
The Impact

Abstract Purpose Chronic obstructive pulmonary disease (COPD) is a significant cause of morbidity and mortality in the United States. Exacerbations— acute worsening of COPD symptoms—can be mild to severe in nature. Increased healthcare resource use is common among patients with frequent exacerbations, and exacerbations are a major cause of the high 30-day hospital readmission rates associated with COPD. Summary This review provides a concise overview of the literature regarding the impact of COPD exacerbations on both the patient and the healthcare system, the recommendations for pharmacologic management of COPD, and the strategies employed to improve patient care and reduce hospitalizations and readmissions. COPD exacerbations significantly impact patients’ health-related quality of life and disease progression; healthcare costs associated with severe exacerbation-related hospitalization range from $7,000 to $39,200. Timely and appropriate maintenance pharmacotherapy, particularly dual bronchodilators for maximizing bronchodilation, can significantly reduce exacerbations in patients with COPD. Additionally, multidisciplinary disease-management programs include pulmonary rehabilitation, follow-up appointments, aftercare, inhaler training, and patient education that can reduce hospitalizations and readmissions for patients with COPD. Conclusion Maximizing bronchodilation by the appropriate use of maintenance therapy, together with multidisciplinary disease-management and patient education programs, offers opportunities to reduce exacerbations, hospitalizations, and readmissions for patients with COPD.

scholarly journals Exacerbations of COPD

2018 ◽  
Vol 27 (147) ◽  
pp. 170103 ◽  
Author(s):  
Christian Viniol ◽  
Claus F. Vogelmeier
Keyword(s):  
Viral Infections ◽  
Inhaled Corticosteroids ◽  
Current Knowledge ◽  
Pneumococcal Vaccination ◽  
Airflow Limitation ◽  
Chronic Obstructive ◽  
Copd Exacerbations ◽  
Recommended Treatment ◽  
Number Of Patients ◽  
The Impact

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. While COPD is a mainly chronic disease, a substantial number of patients suffer from exacerbations. Severe exacerbations are related to a significantly worse survival outcome. This review summarises the current knowledge on the different aspects of COPD exacerbations. The impact of risk factors and triggers such as smoking, severe airflow limitation, bronchiectasis, bacterial and viral infections and comorbidities is discussed. More severe exacerbations should be treated with β-agonists and anticholinergics as well as systemic corticosteroids. Antibiotic therapy should only be given to patients with presumed bacterial infection. Noninvasive ventilation is indicated in patients with respiratory failure. Smoking cessation is key to prevent further COPD exacerbations. Other aspects include choice of pharmacotherapy, including bronchodilators, inhaled corticosteroids, phosphodiesterase-4 inhibitors, long-term antibiotics and mucolytics. Better education and self-management as well as increased physical activity are important. Influenza and pneumococcal vaccination is recommended. Treatment of hypoxaemia and hypercapnia reduce the rate of COPD exacerbations, while most interventional bronchoscopic therapies increase exacerbation risk within the first months after the procedure.

scholarly journals Pharmacotherapy of Chronic Obstructive Pulmonary Disease: A Clinical Review

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Balazs Antus
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Inhaled Corticosteroids ◽  
Phosphodiesterase Inhibitor ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Mortality And Morbidity ◽  
Short Acting ◽  
Significant Burden ◽  
Long Acting

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of mortality and morbidity worldwide. In addition to generating high healthcare costs, COPD imposes a significant burden in terms of disability and impaired quality of life. Unlike many leading causes of death and disability, COPD is projected to increase in many regions of the world as the frequency of smoking is rising and the population is aging. The pharmacological treatment of COPD includes bronchodilators to relax smooth muscle, such as β2-agonists (salbutamol, terbutaline, and fenoterol, short-acting β2-agonists as well as salmeterol, formoterol, and indacaterol, and long-acting β2-agonists) and anticholinergics, such as ipratropium, oxitropium (short-acting anticholinergic), and tiotropium (long-acting anticholinergic). Although airway inflammation in COPD poorly responds to steroids, several inhaled corticosteroids (fluticasone, budesonide, and beclomethasone) are in use in combination with long-acting β2-agonists. Other medications include theophylline (both a bronchodilator and a phosphodiesterase inhibitor) and the phosphodiesterase-4 antagonists, such as roflumilast. Finally, a number of novel long-acting anticholinergics and β2-agonists with once- or twice-daily profiles are in development and clinical testing.

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