Natural History of Chronic Obstructive Pulmonary Disease Exacerbations in a General Practice–based Population with Chronic Obstructive Pulmonary Disease

Rothnie, Kieran J; Müllerová, Hana; Smeeth, Liam; Quint, Jennifer K

doi:10.1164/rccm.201710-2029oc

Cited by 142 publications

(157 citation statements)

References 16 publications

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“…The global burden of COPD is high and appears to be increasing [2]. Importantly, as part of the natural course of the disease, a significant proportion of patients will experience an AECOPD [26]. A key finding from the landmark Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study was that, during 3-year follow-up, 31% of patients experienced at least one AECOPD requiring hospital admission [27].…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Late presentation of acute hypercapnic respiratory failure carries a high mortality risk in COPD patients treated with ward-based NIV

Trethewey

Edgar

Morlet

et al. 2019

Respiratory Medicine

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Section: Accepted Manuscriptmentioning

confidence: 99%

Late presentation of acute hypercapnic respiratory failure carries a high mortality risk in COPD patients treated with ward-based NIV

Trethewey

Edgar

Morlet

et al. 2019

Respiratory Medicine

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“…However, despite the benefits of inhaled pharmacologic treatments for COPD, a significant number of patients have persistent symptom and exacerbation burden (classified as GOLD Group "D"). Development of a therapeutic procedure that could reduce the risk for future exacerbation is an important research objective [5].…”

Section: Introductionmentioning

confidence: 99%

Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3)

Slebos¹,

Degano²,

Valipour³

et al. 2020

BMC Pulm Med

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Background: Targeted lung denervation (TLD) is a bronchoscopically delivered ablation therapy that selectively interrupts pulmonary parasympathetic nerve signaling. The procedure has the potential to alter airway smooth muscle tone and reactivity, decrease mucous secretion, and reduce airway inflammation and reflex airway hyperresponsiveness. Secondary outcome analysis of a previous randomized, sham-controlled trial showed a reduction in moderate-to-severe exacerbations in patients with COPD after TLD treatment. A pivotal trial, AIRFLOW-3 has been designed to evaluate the safety and efficacy of TLD combined with optimal medical therapy to reduce moderate or severe exacerbations throughout 1 year, compared with optimal medical therapy alone. Methods: The study design is a multicenter, randomized, full sham bronchoscopy controlled, double-blind trial that will enroll 400 patients (1:1 randomization). Key inclusion criteria are FEV 1 /FVC < 0.7, FEV 1 30 to 60% of predicted, post-bronchodilator, ≥ 2 moderate or 1 severe COPD exacerbations in the prior year, and COPD assessment test (CAT) ≥ 10. Primary objective will be the comparison of moderate or severe COPD exacerbations through 12 months of TLD therapy with optimal medical therapy versus optimal medical therapy alone. The sham group will be allowed to cross over at 1 year. Patients will be followed for up to 5 years. Discussion: The multicenter, randomized, full sham bronchoscopy controlled, double-blind AIRFLOW-3 trial will evaluate the efficacy of TLD to reduce moderate or severe COPD exacerbations beyond optimal medical therapy alone. The target population are patients with COPD, who suffer persistent symptoms and exacerbations despite optimal treatment, defining an unmet medical need requiring novel therapeutic solutions. This trial is registered at clinicaltrials.gov: NCT03639051.

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“…Rothnie and colleagues recently show that almost 52% of COPD patients do not exacerbate in the first year of follow up and that a 26% do not exacerbate during a 10 years follow up. Treating these patients with medications that only prove their efficacy on exacerbation rate would not be relevant, but it remains difficult if not impossible to predict the risk of exacerbation accurately on an individual basis [21].…”

Section: Discussionmentioning

confidence: 99%

Randomized controlled trials of pharmacological treatments to prevent COPD exacerbations: applicability to real-life patients

et al. 2019

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Background: In patients with chronic obstructive pulmonary disease, all efforts should be made to prevent exacerbations because each event modifies the trajectory of the disease. Treatment recommendations are mostly built on results from randomized controlled trials (RCTs) whose methodology ensure internal validity. However, their relevance may be compromised by the lack of generalizability, due to poor representability of study populations compared to real-life patients. In order to delimit to whom the results of studies on current and future treatments apply, we sought to identify and characterize the fraction of COPD population that would be eligible for inclusion into RCTs aiming at decreasing exacerbation risk. Methods: We used the Initiatives-BPCO database, a French cohort of 1309 real-life COPD patients monitored in academic centers. We identified industry-sponsored phase III and IV trials that enrolled more than 500 patients, lasted at least one year and used exacerbations related endpoints. Eligibility criteria were extracted from each trial and applied to the patients. Results: The eligibility criteria of 16 RCTs were applied to the 1309 patients. The most discriminating eligibility criteria were FEV1, minimum exacerbation rate in the previous year and smoking history, responsible for the exclusion of 39.9, 36.7 and 16.8% of patients, respectively. Altogether, 2.3 to 46.7% of our patients would have satisfied all eligibility criteria. Conclusion: These analyses confirm that an important gap exists between real-life patients and clinical trials populations in COPD, which limits the relevance of results and therefore should be considered when grading levels of evidence and designing future studies.

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Natural History of Chronic Obstructive Pulmonary Disease Exacerbations in a General Practice–based Population with Chronic Obstructive Pulmonary Disease

Cited by 142 publications

References 16 publications

Late presentation of acute hypercapnic respiratory failure carries a high mortality risk in COPD patients treated with ward-based NIV

Late presentation of acute hypercapnic respiratory failure carries a high mortality risk in COPD patients treated with ward-based NIV

Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3)

Randomized controlled trials of pharmacological treatments to prevent COPD exacerbations: applicability to real-life patients

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