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3rd December 2024
The monoclonal antibody benralizumab, which is currently used in the treatment of severe asthma, could help to treat exacerbations in asthma and COPD, according to a new UK trial.
Benralizumab was found to be more effective than a dose of steroids when patients had gone to urgent care clinics or emergency departments with acute symptoms and high eosinophil counts. This reduced the need for further treatment and hospitalisations.
Researchers at King’s College London said the findings could be ‘game-changing’ in an area of medicine that had not changed in 50 years.
In the trial, patients having an asthma or COPD attack were randomly assigned into three groups. The first was treated with a benralizumab injection and placebo tablets, the second received the standard of care of prednisolone 30mg daily for five days plus a placebo injection, and the third received both a benralizumab injection and the standard of care prednisolone.
After 28 days cough, wheeze, breathlessness and sputum were found to be better in patients who had received benralizumab and after 90 days, there were four times fewer people in the benralizumab group that failed treatment compared with those who only received prednisolone.
Writing in The Lancet Respiratory Medicine, the researchers also noted that treatment with benralizumab ‘took longer to fail’, meaning fewer visits to a GP or hospital. There was also an improvement in the quality of life for people with asthma and COPD.
Almost three quarters (74%) of patients who received standard of care prednisolone needed further treatment within 90 days, highlighting the poor outcomes currently seen with short-course steroids when treating eosinophilic exacerbations, they concluded.
The safety profile of benralizumab injections was similar to previous studies and the researchers said it could potentially be given in a GP practice or emergency department.
Eosinophilic exacerbations make up to 30% of COPD flare-ups and almost 50% of asthma attacks, with two million exacerbations of this type in the UK per year.
Study leader Professor Mona Bafadhel, director of the King’s Centre for Lung Health, said: ‘Benralizumab is a safe and effective drug already used to manage severe asthma.
‘We’ve used the drug in a different way – at the point of an exacerbation – to show that it’s more effective than steroid tablets, which is the only treatment currently available.’
She added that the big advancement in this study was discovering that targeted therapy works in asthma and COPD attacks.
‘Instead of giving everyone the same treatment, we found targeting the highest risk patients with very targeted treatment, with the right level of inflammation was much better than guessing what treatment they needed,’ she said.
Dr Samantha Walker, director of research and innovation, at the charity Asthma + Lung UK, said: ‘It’s great news for people with lung conditions that a potential alternative to giving steroid tablets has been found to treat asthma attacks and COPD exacerbations.
‘But it’s appalling that this is the first new treatment for those suffering from asthma and COPD attacks in 50 years, indicating how desperately underfunded lung health research is.’
The publication of this research comes as the long-awaited NICE/BTS/SIGN joint guidelines on management of asthma were launched.
In November, a report revealed that a digital asthma tool could reduce emergency appointments and save NHS £25m annually.
A version of this article was originally published by our sister publication Pulse.
2nd October 2024
The rapidly developing area of technology and artificial intelligence (AI) within respiratory medicine and science was under the spotlight at this year’s European Respiratory Society (ERS) Congress, including the use of voice recording technology in identifying chronic obstructive pulmonary disease (COPD) exacerbations.
A trial showing vocal changes recorded on a smartphone can signal the start of a COPD exacerbation was among the research presented under the Congress’s humans and machines theme.
In the prospective cohort study, patients with COPD were asked to record their voices via a smartphone app every day for 12 weeks and also complete a daily report on any COPD symptoms.
Using the app, patients recorded themselves saying ‘aah’ for as long as they could manage in one breath and then either read a short paragraph of a story or answer a question.
A total of 11 COPD patients completed the daily report and voice tasks, equating to 1,691 voice recordings in total.
During the 12-week study, there were 16 occasions when a patient experienced a COPD exacerbation, six of which were treated.
Analysis found specific speech features were significantly different at the onset and peak of a COPD exacerbation. Patients’ voices became higher pitched when an exacerbation was imminent, and voices also become more breathy or hoarse when an exacerbation was beginning.
Lead author Loes van Bemmel, a researcher in the department of respiratory medicine at Maastricht University Medical Centre in the Netherlands, said these preliminary results needed to be validated in larger numbers of patients with COPD.
‘If we are able to do this, it would pave the way for early detection and diagnosis of exacerbations in the home environment. This would enable patients to manage these events themselves at home,’ she said.
‘While every disease is different, speech analysis could potentially help in other respiratory diseases as well. We suspect there are speech biomarkers for many respiratory diseases.’
ERS Congress co-chair Professor Judith Löffler-Ragg said the research presented at this year’s event under the theme of ‘Humans and machines: getting the balance right’, including this COPD study, was pioneering and should guide future developments.
‘It is extremely important that we view developments in technology, and specifically AI, with an open mind but also a critical eye,’ she said.
‘Our vision is to advance personalised medicine through the responsible use of AI, continuously improving respiratory medicine.’
9th July 2024
Professor Mona Bafadhel tells Katherine Price about developing a new tool that has identified less obvious yet crucial cardiovascular disease risk indicators such as chronic obstructive pulmonary disease. She hopes the tool will impact health inequalities by better predicting at-risk individuals and ensuring previously under-detected populations can access preventative therapies.
Professor Mona Bafadhel is the chair of respiratory medicine at King’s College London and director of the King’s Centre for Lung Health. Her work on chronic obstructive pulmonary disease (COPD) has recently led to her working with colleagues across King’s College London and the Universities of Oxford, Nottingham, Bristol and Edinburgh to support the development of a new cardiovascular disease(CVD) predictive calculator.
COPD is the third leading cause of death worldwide, causing more than three million deaths in 2019. Nearly 90% of deaths in patients under the age of 70 occur in low- and middle-income countries, and it’s estimated that in the UK, at least 4.9% of people over the age of 40 have COPD. By 2050, it’s predicted that global COPD prevalence will approach 600 million cases and become the leading cause of death globally. ‘[This] is an important group of patients,’ stresses Professor Bafadhel.
Among COPD patients, cause of death is often CVD, Professor Bafadhel explains. She and colleague Dr Richard Russell, head of department of the Peter Gorer Department of Immunobiology, were aware of the association between COPD and CVD based on their clinical experience and an increasing body of evidence. However, they wanted to understand more about the link between the two.
CVD is also a leading cause of death globally, responsible for an estimated 17.9 million deaths in 2019. Research into risk factors is abundant, but the tools available in clinical practice to score cardiovascular risk were unable to offer much insight into the CVD risk in a patient with COPD.
‘Indeed, it appears that current risk tools were underestimating the actual cardiovascular risk associated with patients with COPD,’ adds Professor Bafadhel.
The duo liaised with Professor Julia Hippisley-Cox from the University of Oxford and Carol Coupland from the University of Nottingham and others, who designed three iterations of QRISK – the CVD risk score that has been used across the NHS since 2009. It involves measuring patients’ blood pressure, age and medical history to identify those at high risk of developing CVD.
However, even QRISK3 does not capture several conditions that have recently been associated with increased CVD risk, including COPD, meaning it will potentially underestimate risk in these groups, who may subsequently not be offered beneficial interventions.
The new research, utilising several UK primary care databases to assess a cohort of more than 16.5 million UK citizens for derivation and validation of the algorithm, led to the development of QRISK4 or QR4, which showed that COPD was indeed a risk factor. In fact, QR4 outperformed three widely used international CVD scoring models, including QR3, due to the size and validity of the data, accurately identifying more high-risk patients.
‘The accuracy required has to be very vigorous with regard to validation tools and replication models,’ explains Professor Bafadhel. ‘It took a rigorous amount of work as standard because my collaborators Julia and Carol have experience of getting this into patient practice with QRISKs 1, 2 and 3, so we were guided and as sure as we can be that we were doing it even more rigorously for QR4.’
Like QR3, QR4 – if approved – would be a free-to-access web platform into which clinicians can enter details about patient health to generate a percentage risk of them developing CVD in 10 years’ time. Thresholds are also offered to inform clinicians as to when preventative treatment should be offered.
The difference is the inclusion of seven new risk factors. In addition to COPD, this includes learning disabilities, Down syndrome, four cancer types (blood, lung, oral and brain), pre-eclampsia and postnatal depression. While risk factors such as smoking and high cholesterol are well-recognised, this latest research identifies less obvious yet crucial risk indicators and highlights how other significant conditions impact on heart health.
Not only was an increased risk of severe cardiovascular events in patients with COPD identified, but the greatest effect was seen in females – a surprise for Professor Bafadhel.
Evidence previously suggested that COPD most commonly affected men, but more women appear to have COPD than first thought. What’s more, ‘it’s clear actually that women [with COPD] have more susceptibility to cardiovascular risk,’ Professor Bafadhel says, stressing that clinicians need to consider COPD as a diagnosis and confirm it with spirometry, especially in women, to mitigate these cardiovascular risks.
The risk was also highest in younger patients with COPD, which, for Professor Bafadhel, was another sign that conditions such as COPD need to be diagnosed earlier.
Ultimately, the research underlines the importance of prescribing therapies that reduce CVD risk, including optimising inhaled therapies, to reduce mortality.
By integrating these seven risk factors into the QR4 model, the researchers were able to develop a more nuanced and comprehensive tool for predicting CVD, ensuring preventative strategies are more personalised, inclusive and cater to the needs of a broader and more diverse population. It also provides clinicians with the clearest picture yet of individuals’ risk of developing heart and circulatory diseases.
Although the QR4 is based on UK population data, Professor Bafadhel hopes that other countries can use the research and their own population data to assess their own algorithms and tools. For countries with fewer resources, she says available tools can be used, mindful that the data may not be population relevant.
The hope is that, by providing a more accurate CVD risk estimation, QR4 should lead to significant improvements in health outcomes, particularly among populations whose risk may have previously been under-detected. If implemented, it is estimated that optimising the care of COPD patients would save more than 2,500 lives a year in the UK and promote earlier recognition of both COPD and the associated cardiovascular risk.
Professor Bafadhel argues the most important impact of this research would be driving awareness of the interlinked risks of CVD and COPD across the multidisciplinary field, and of how that risk can be modified.
‘We just haven’t had enough investment and funding in [COPD]. People may not know what it is until it’s too late. We really do need to improve the global awareness of it,’ she says.
‘We need to diagnose COPD earlier and be familiar with what COPD is. We need to optimise COPD treatments, including all the available tools we have. And then we need to try and understand what causes that very close association to cardiovascular disease, and of course exacerbations.’
She also highlights the importance of preventing CVD, catastrophic events and deaths by optimising COPD pharmacological treatment as well as primary prevention.
The researchers anticipate that QR4 will supersede QR3, although there is currently no timeline for this. Nevertheless, the next five years are expected to be an exciting time in the COPD field that will further shape understanding of this debilitating condition, according to Professor Bafadhel.
While she and her colleagues are looking at platelets in patients with COPD, other multidisciplinary groups are investigating pulmonary lung-heart events in this group – research Professor Bafadhel hopes will reduce inequalities, raise standards and empower patients to ensure they get the best treatment they need, when they need it.
‘Gone are the days where we think we can’t do anything for a person with COPD,’ she says. ‘We now have multiple tools, from physiotherapy to inhaled treatments, to non-invasive and invasive surgery, and in the next few months, hopefully also biologics in COPD.’
4th July 2024
The monoclonal antibody dupilumab (brand name Dupixent) has been approved by the European Commission for eligible adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils.
The first-ever targeted therapy to be approved for patients with COPD, dupilumab is now indicated as an add-on maintenance treatment for patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta-2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
Dupilumab targets interleukin-4 and interleukin-13 pathways – the key drivers of type 2 inflammation – and is the first biologic approved for COPD, as well as being the first new treatment for the disease approved in Europe for over a decade.
Sanofi and Regeneron estimate that around 220,000 patients with COPD in the EU could be eligible for treatment with dupilumab.
The approval is based on results from the phase 3 BOREAS and NOTUS trials, which evaluated the efficacy and safety of dupilumab in adults who had uncontrolled COPD with blood eosinophils ≥300 cells per μL.
The primary endpoint in both trials was the annualised rate of moderate or severe exacerbations.
Patients were on background maximal standard-of-care inhaled therapy, with nearly all on triple therapy, and were randomised to receive subcutaneous dupilumab (300 mg) or placebo every two weeks.
Dupilumab patients in BOREAS (n=468) experienced a 30% reduction in the annualised rate of moderate or severe COPD exacerbations over 52 weeks compared to placebo (BOREAS n=471).
In NOTUS (n=470) this was a 34% reduction compared to placebo (NOTUS n=465).
In terms of the secondary and other endpoints, there were improvements in lung function (prebronchodilator FEV1) from baseline by 160 mL and 139 mL at 12 weeks compared to 77 mL and 57 mL in the placebo group. These were observed as early as Week 2 and 4 and were sustained at Week 52 in both trials.
The researchers also noted improvements in health-related quality of life, which was statistically significant in BOREAS and nominally significant in NOTUS, as assessed by the St. George’s Respiratory Questionnaire.
Safety results in both studies were found to largely be consistent with the known safety profile of dupilumab in its approved indications.
Speaking of dupilumab’s potential to ‘redefine the treatment landscape’ of COPD, George D. Yancopoulos, board co-chair, president and chief scientific officer at Regeneron, said: ‘The approval of Dupixent for COPD is a long-awaited turning point for those who struggle to breathe even through the simplest of tasks, while also facing the risk of hospitalisation, irreversible health decline and feelings of hopelessness.’
Paul Hudson, chief executive officer at Sanofi, added: ‘Patients with uncontrolled COPD have been waiting for a new treatment approach for many years, so we are thrilled to bring to market the first biologic to target an underlying cause of this devastating disease to reduce COPD exacerbations and improve lung function.’
This latest approval means dupilumab is indicated for certain patients with six conditions in the EU: moderate-to-severe atopic dermatitis, severe asthma, chronic rhinosinusitis with nasal polyposis, moderate-to-severe prurigo nodularis, eosinophilic oesophagitis, and now COPD.
14th September 2023
Using lung progenitor cell transplantation in patients with chronic obstructive pulmonary disease (COPD) appears to improve symptoms and could lead to a cure, according to a study presented at the recent European Respiratory Society (ERS) International Congress 2023 in Milan, Italy.
It has been previously shown that P63+ progenitor cells, which are used by the body to repair and replace damaged tissue, are able to induce lung epithelium regeneration in animal models.
Consequently, in this first-in-human phase 1 clinical trial (abstract OA4297), researchers set out to investigate the efficacy and safety of taking autologous P63+ progenitor cells transplanted into the lungs of patients with COPD.
They demonstrated that the use of P63+ progenitor cells in those with COPD enabled patients to breathe better, walk further and have improved quality of life. This is the first time researchers have shown it‘s possible to repair damaged lung tissue in patients with COPD using their own lung cells.
The trial included 17 COPD patients with a diffusing capacity of the lungs (DLCO) of less than 80% of the predicted value and three control patients. Individuals were autologously transplanted with the P63+ progenitor cells through bronchoscopy, followed by subsequent assessment for both safety and efficacy within 24 weeks.
The cell treatment was well tolerated by all patients and following transplantation, the median DLCO of treated patients increased from a baseline value of 30.00% to 39.70% after 12 weeks and still further to 40.30% after 24 weeks.
When it came to quality of life, the average St George’s Respiratory Questionnaire score of those receiving cell therapy group decreased from 51.3% at baseline to 44.2% after treatment. The median six-minute-walk distance increased from 410m to 447m at 24 weeks.
In addition, two patients with mild emphysema showed resolution of the lesions at 24 weeks by CT imaging.
Professor Wei Zuo, chief scientist of the study and professor in the school of medicine at Tongji University, Shanghai, China, told the congress: ‘P63+ progenitor cells are known for their ability to regenerate the tissues of the airways, and previously we and other scientists have shown in animal experiments that they can repair the damaged epithelial tissue in the alveoli.‘
He added: ‘We found that P63+ progenitor cell transplantation, not only improved the lung
function of patients with COPD, but also relieved their symptoms, such as shortness of breath, loss
of exercise ability and persistent coughing. This means that the patients could live a better life, and
usually with longer life expectancy.
‘If emphysema progresses, it increases the risk of death. In this trial, we found that P63+ progenitor cell transplantation could repair mild emphysema, making the lung damage disappear. However, we
cannot repair severe emphysema yet.‘
Commenting on the ‘encouraging‘ results, Professor Omar Usmani, head of the European Respiratory Society group on airway disease and professor of respiratory medicine at Imperial College London, UK, added: ‘COPD is in desperate need of new and more effective treatments, so if these results can be confirmed in subsequent clinical trials it will be very exciting. It is also very encouraging that two patients with emphysema responded so well.
‘A limitation of this study is that the uptake of the progenitor cells when they were transplanted back into the patients is uncontrolled. So we do not know whether the lungs of some patients responded better to the transplantation than other. We hope this information may become apparent in future studies.‘
The researchers are planning a phase II trial of the treatment, which will evaluate its efficacy in a
larger group of patients.
11th September 2023
Guidance on how global warming can be addressed in clinical practice has been outlined by the European Respiratory Society (ERS) in its latest consensus statement on climate change and respiratory health.
Published in the European Respiratory Journal, the statement describes climate change as ‘an unfolding major planetary and health crisis’, and a major threat to those with common lung conditions.
This, it says, is linked to the frequent and extreme weather events, prolonged aeroallergen seasons and poorer air quality associated with climate change, which can lead directly to a worsening of health and an increased risk of death.
Traditionally, clinicians have been involved in climate change adaptation strategies such as identifying vulnerable groups and providing advice on how they can protect themselves during heatwaves, for example.
However, the ERS says this clinical role has now expanded to focus on both human and planetary health, which includes contributing to the reduction in greenhouse gas emissions.
According to the ERS, subsequent changes to clinical practice could therefore include promoting green prescriptions such as inhalers; focusing efforts on smoking eradication; and encouraging patients, where appropriate, to engage with nature, take active modes of transport and make more sustainable food choices.
Professor Zorana Jovanovic Andersen, chair of the ERS Environment and Health Committee and professor of environmental epidemiology at the University of Copenhagen, who was one of the authors, said: ‘As respiratory doctors and nurses, we need to be aware of these new risks and do all we can to help alleviate patients’ suffering. We also need to explain the risks to our patients so they can protect themselves from adverse effects of climate change.‘
The consensus statement also highlights that climate change will have a disproportionately greater adverse effect on individuals living with respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD).
It outlines some of the health risks of climate change such as a decline in lung function, increases in allergic responses and/or new cases of chronic (asthma, COPD, lung cancer) or infectious (pneumonia, influenza, tuberculosis, Covid-19) respiratory diseases.
It also identifies a higher risk of exacerbations for existing respiratory diseases, increased use of medication, emergency department visits, hospitalisations and death.
The fact that children are more susceptible to the impact of climate change on lung health is also highlighted, including the fact that the prevention of chronic respiratory disease should start as early as possible as many chronic lung diseases in adults have childhood origins.
Several previous reviews have provided extensive summaries of the different mechanisms by which climate change affects respiratory health, as well as outlining adaptation strategies. The latest statement provides an overview of all major pathways linking climate change with lung health.
While it summarises all of the available evidence, the authors also recognise some gaps in current knowledge. For instance, there is the need for further research to fully map the burden of climate change on respiratory diseases under different global warming scenarios and to understand underlying biological mechanisms, as well as identifying pathways of adaptation that can be translated into public health policies.
Professor Jovanovic Andersen, added: ‘Climate change affects everyone’s health, but arguably, respiratory patients are among the most vulnerable. These are people who already experience breathing difficulties and they are far more sensitive to our changing climate. Their symptoms will become worse, and for some this will be fatal.
‘Air pollution is already damaging our lungs. Now the effects of climate change are becoming a major threat to respiratory patients.’
Indeed, the deleterious respiratory effects of the particulate matter contained within air pollution, are already known to provide a mechanism through which lung cancer can develop among individuals who have never smoked.
14th August 2023
Patients who have low vitamin K levels have a reduced ventilatory capacity and are more likely to self-report asthma, COPD or wheezing, according to a study by researchers from Copenhagen University Hospital and the University of Copenhagen.
The study, which was published in the journal ERJ Open Research, set out to assess whether lower vitamin K status was associated with lung function and lung disease/symptoms. The researchers focused on the measurement of dephosphorylated-uncarboxylated MGP (dp-ucMGP), which serves as an inverse plasma biomarker for vitamin K status.
The team recruited members of the general population and invited them to a health examination to complete questionnaires and undergo spirometry, together with measurement of plasma dp-ucMGP. Lung function assessments were the forced expiratory volume during the first second (FEV1) and forced vital capacity (FVC). FEV1/FVC-ratio was calculated as the ratio between these two measurements.
In the questionnaires, researchers asked participants whether they had ever been diagnosed with either asthma or COPD, or whether they had experienced wheezing during the last 12 months. They then used multivariable logistic regression to assess the associations between dp-ucMGP and the dichotomous variables, COPD, asthma and wheezing.
A total of 4,092 individuals aged 24-77 years were included in the analysis.
Lower vitamin K status, reflected by higher dp-ucMGP levels, was associated with lower FEV1 and FVC. However, dp-ucMGP was not associated with the FEV1/FVC-ratio. A lower status was significantly associated with COPD (Odds ratio, OR = 2.24, 95% CI 1.53 – 3.27), wheezing (OR = 1.81 95% CI 1.44 – 2.28) and asthma (OR = 1.44 95% CI 1.12 – 1.83).
Lead author of the study, Dr Torkil Jespersen, said: ‘We already know that vitamin K has an important role in the blood, and research is beginning to show that it’s also important in heart and bone health, but there’s been very little research looking at vitamin K and the lungs.
‘To our knowledge, this is the first study on vitamin K and lung function in a large general population. Our results suggest that [it] could play a part in keeping our lungs healthy.‘
The vitamin is found in leafy green vegetables, vegetable oils and cereal grains. It plays a role in blood clotting, although, clinically, vitamin K antagonists are used as anticoagulants to control bleeding.
15th June 2023
Using capnography breath data, a machine learning algorithm diagnosed chronic obstructive pulmonary disease (COPD) with an accuracy of 91%.
In the study, published in Respiratory Research, UK researchers used the N-Tidal device and applied machine learning techniques to capnography data to help distinguish the CO2 recordings (i.e. capnograms) of patients with and without COPD.
The team utilised capnography data from four clinical studies and developed machine learning algorithms to discriminate COPD from non-COPD, which comprised a group of patients who were either healthy or who had other conditions including asthma, heart failure, pneumonia, breathing pattern disorder and motor neurone disease.
The team developed three machine learning models and the predictability for COPD was assessed using receiver operator characteristic (ROC) curves and the subsequent estimates of sensitivity, specificity negative and positive predictive values.
A total of 88,186 capnograms were collected from 295 patients, with each patient providing an average of 299 capnograms over 179 days.
The highest accuracy (91.3%) was provided by an XGBoost model with a corresponding sensitivity of 91.5% and a specificity of 91.4% for the diagnosis of COPD. Even on an unseen test data set, the XGBoost model still had an accuracy of 90%.
According to the manufacturer of the N-Tidal device, TidalSense, it takes under five minutes from the start of the breath test to diagnosis.
Based on the findings of the current study, the researchers concluded that the ability of the N-Tidal capnography device to accurately diagnose COPD in near-real-time lends support to its future use in a clinical setting.
COPD led to 3.23 million deaths in 2019 and was the third leading cause of global deaths. Spirometry is generally considered to the be gold standard diagnostic tool for COPD, and its use is on the rise, yet it is also one of the major causes for misdiagnosis. Capnography is a widely used technique that could be used to diagnose COPD.
8th June 2023
Diagnostic spirometry is increasingly used to confirm the presence of chronic obstructive pulmonary disease (COPD) but there are still existing barriers to more widespread use, according to a recent analysis.
Published in the journal NPJ Primary Care Respiratory Medicine, Swedish researchers examined whether the proportion of patients with diagnostic spirometry had increased over time. The team originally explored spirometry use in 2005 but re-assessed the level of use following the introduction of national guidelines in 2014. In the current study, they also set out to determine any factors associated with omitted or incorrectly interpreted spirometry.
Using data from medical reviews and a questionnaire from primary and secondary care patients diagnosed with COPD between 2004 and 2010, the researchers compared the findings from a cohort diagnosed between 2000 and 2003.
Among 703 patients with a COPD diagnosis between 2004 and 2010, 88% of these had diagnostic spirometry, compared with 59% (p < 0.001) in the previous cohort. Furthermore, the correct interpretation of spirometry results also increased between the two periods (75% vs 82%; p = 0.010).
In further analysis, it became clear that factors associated with not having diagnostic spirometry were: current smoking (Odds ratio, OR = 2.21, 95% CI 1.36 – 3.60), low educational level (OR = 1.81, 1.09 – 3.02) and being managed in primary care (OR = 2.28, 95% CI 1.02 – 5.14). The authors speculated that the lower use of spirometry in current smokers was largely because physicians probably felt the diagnosis was more likely and hence did not require confirmation.
While greater use of diagnostic spirometry was encouraging, the authors suggested that there was still a need for continuous medical educational activities to increase diagnostic accuracy.
The use of diagnostic spirometry has been advocated as a means to identify COPD in those with airflow obstruction and respiratory symptoms. However, spirometry is under-used in practice, with a real-world study finding that data from the technique was only used in 43.5% of nearly 60,000 COPD patients.
In fact, not using diagnostic spirometry potentially means that patients could be either under- or over-diagnosed with the condition. For example, it has been suggested that approximately 70% of COPD worldwide may be under-diagnosed and 30-60% of patients over-diagnosed.
An inadequate assessment with diagnostic spirometry has important implications for patient management. For example, a late COPD diagnosis, can result in a higher exacerbation rate, increased comorbidities and costs compared with an early diagnosis.
25th May 2023
Most patients presenting with breathlessness should have a diagnosis and comprehensive treatment plan in place with six months, a support tool published by NHS England to reduce variation in care says.
Breathlessness is associated with high use of healthcare services accounting for 4% of GP consultations and 5% of emergency department attendances, NHS England said.
Yet despite the burden to the patient and the NHS, delays to diagnosis and misdiagnosis are common, the toolkit notes.
This includes 58% of patients with COPD who present with respiratory symptoms for over five years before diagnosis, as well as 41% of patients with heart failure.
Patients with chronic breathlessness are likely to need multiple investigations and should be provided with self-management advice, have lifestyle issues addressed and support for mental health from the first presentation, the guidance states.
Timeliness is key with a proactive approach to reassessment rather than waiting for patients to keep highlighting their breathlessness, it says, and in a third of patients the cause will be multifactorial.
The guidance sets out diagnostic pathway for initial investigations of chronic breathlessness lasting more than eight weeks including ECG, spirometry and FeNO with suggestions for further tests should be diagnosis be unclear.
Referral to respiratory physician or cardiologist is the third step should other investigations provide no explanation, the pathway says.
‘If there is no obvious cause(s) for breathlessness after robust investigation, fitness and lifestyle factors should be addressed,’ the toolkit continues. ‘Consider referral for therapeutic interventions for alcohol reduction, weight management, physical activity improvement and psychosocial support.’
It notes the guidance is not intended to override clinical judgment in individual cases.
In its annual report on COPD care, Asthma and Lung UK said almost a quarter of patients wait five year or more before their condition is diagnosed and 12% of 6,500 patients surveyed had waited more than a decade.
Some community diagnostic centres have been piloting the use of a pre-diagnosis breathlessness pathway, the charity said, but this approach now needs to be rolled out nationally as a matter of urgency.
The goal would be for any patients presenting with breathlessness with no obvious diagnosis to be referred to a diagnostic hub to have an assessment by heart, respiratory and mental health experts before onward specialist referral and treatment where necessary.
Dr Daryl Freeman, Primary Care Respiratory Society committee member and associate clinical director at Norfolk Community Health & Care said: ‘The NHSE breathlessness pathway is an opportunity to fine tune primary care diagnosis of breathlessness and look at how they can develop their PCN hublets or refer into community based diagnostic hubs if they exist.
‘The algorithm is useful I feel and is particularly useful for allied health professionals looking after patients with new onset breathlessness.’
This story was originally published by our sister publication Pulse.
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