Friday, September 23, 2016

Chronic Respiratory Symptoms with Normal Spirometry: A Reliable Clinical Entity? (Blue journal 2016)

Dear friends we are happy to present you new interesting review on new clinical entity: chronic respiratory symptoms in persons with normal spirometry!
The 2001 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report defined five stages of spirometric severity (post-bronchodilator FEV1/FVC≥0.7): 0, and 1 (mild) to 4 (very severe). GOLD Stage 0 was defined by chronic cough and sputum production or chronic mucus hypersecretion (CMH) alone with preserved FEV1/FVC. Subsequently, GOLD 0 was discarded as further evidence of COPD development in subjects with GOLD 0 was not more likely to develop.
When expanding symptomatic burden in GOLD 0 to include other chronic respiratory symptoms, such as dyspnea, wheeze, poor quality of life, limited physical activity, and ‘COPD exacerbations-like’ events needing health resources, symptomatic smokers with normal FEV1 resulted in larger risk of death. We review the evidence supporting a relationship between an increased symptom burden, long-term FEV1 decline and development of COPD. We also address the evidence for the presence of respiratory symptoms with normal FEV1 in smokers as a potential clinical entity. This subset of symptomatic patients encompasses a compelling category of smokers with normal spirometry but increased risk for poor outcomes. What exactly these symptomatic patients with intact FEV1 represent remains unclear. Whether they exemplify smoking-induced just a broadening of respiratory abnormalities or a distinct clinical entity that precedes the development of COPD or both remains unknown. Other aims, such as providing information on pathogenesis and future areas of research, are just as vital. What ultimately prevails however is the importance of the public health message to the frightening presence of chronic respiratory symptoms in the whole population.
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Wednesday, September 21, 2016

Asthma 2016 Guidelines: The 2016 update by the British Thoracic Society (free full text)

Today was published an important update to British Thoracic Society guidance on the management of asthma!
Diagnosing asthma
The guideline, produced jointly by the British Thoracic Society (BTS) and the Scottish Intercollegiate Guidelines Network (SIGN) emphasises that there is still no single test that can definitively diagnose asthma and an individual’s asthma status can change over time.
It recommends that if a health professional suspects asthma, they should undertake a ‘structured clinical assessment’ using a combination of patient history, examination and tests to assess the probability of asthma. 
The history should include a review of the following:
  • Symptoms of cough, breathlessness, wheeze and chest tightness that have varied over time
  • Any history of recurrent attacks of symptoms
  • Any wheeze previously recorded by a health professional
  • A personal or family history of allergic conditions such as eczema and allergic rhinitis
  • Objective evidence of variability over time in obstruction to a patient’s airflow (using the results of lung function tests)
  • The absence of any pointers to an alternative diagnosis to asthma.
Quality assured spirometry is spotlighted as the key frontline breathing test to be performed in most situations with adults and children over 5 years of age.  It is important that spirometry is quality assured i.e. professionals are trained and experienced in preparing and delivering the test as well as analysing the results.
If the test shows obstruction to the patient’s airflow which reverses with treatment, this strongly supports a diagnosis of asthma.
But a normal spirometry result does not always exclude an asthma diagnosis – especially if a patient has no symptoms at the time. It may be necessary for healthcare professionals to repeat spirometry when a patient has symptoms, and/or use different breathing tests - and observe over time.
One, often secondary, breathing test that can be carried out, involves measuring an individual’s fractional exhaled nitric oxide (FeNO) - a gas found in slightly higher levels in people with asthma. An increase suggests inflammation of the airways, and supports, but doesn’t prove, a diagnosis of asthma.
The guideline helps health professionals to assign patients into 3 groups based on the probability they have asthma; either high, intermediate or low.  It then summarises the key treatment and management actions to be taken for each group.
If the probability of asthma is high, health professionals should start a carefully monitored trial of treatment. If patients respond well, according to lung function tests or symptom questionnaires, this will confirm the diagnosis.   Health professionals should code their records as ‘suspected asthma’ until a diagnosis is confirmed and should make a clear record on what basis the diagnosis was confirmed. If the probability is low, further tests or immediate referral to a lung specialist may be appropriate.
Treating asthma
The updated guideline also includes new or revised content in the following areas: asthma drug treatment (replacing the previous stepwise approach), non-drug treatments, supported self-management, and the role of telehealthcare.
Key highlights include: 
  • Short acting beta2 agonists - a group of drugs that can provide quick relief of asthma symptoms - are the key ‘rescue therapy’ from symptoms or asthma attacks and can form part of all treatment plans, but should rarely be used on their own
  • A key emphasis on medication to prevent future asthma attacks - inhaled corticosteroids remain the most effective ‘preventer’ drug for all adults and children
  • Asthma inhalers should not be prescribed generically to avoid patients being given an unfamiliar device that they may not know how to use properly
  • If a patient has poor control of their asthma, it is essential to check whether they are using their current drug treatment correctly and regularly, before stepping up treatment
  • Weight loss initiatives – including dietary and exercise programmes – can be offered for overweight or obese adults and children with asthma and may improve their asthma control 
  • Each patient should be offered a written asthma action plan as it is key to the effective management of their asthma
  • The use of new electronic technologies can help in the delivery of asthma care, and evidence shows they can be at least as good as traditional methods, although outcomes do vary
Approaches include; games to encourage children to take their medication, remote consultations, automated treatment reminders, and computerised decision-support systems for health professionals. The guideline says they can be considered according to local need
  • Women with asthma who are pregnant should be informed of the importance of continuing their asthma medication during pregnancy for the health of both mother and baby
Dr John White, British Thoracic Society member and Consultant Respiratory Physician, York NHS Foundation Trust, who co-chaired the group that delivered the updated BTS/SIGN Guideline, said:
‘Asthma is a complex disease and symptoms can vary over time.  In addition, evidence shows there’s still no single ‘magic bullet test’ for asthma. This all means that diagnosis isn’t always easy.
This update should be really valuable as it gives healthcare professionals an evidence-based but highly practical approach to suspecting and confirming a diagnosis of asthma, as well as giving the latest guidance on the most appropriate treatments and interventions to combat the disease.  
The guideline also reinforces previous messages that remain vital in the battle against asthma. It is critical, for example, that everyone with the condition is offered a written personalised action plan and review, and that inhalers are only prescribed after patients have received training in using them and demonstrate adequate technique.
We do hope that health, social care and education professionals can work together with people with asthma in using these guidelines to provide the best care possible.’   
SIGN is part of Healthcare Improvement Scotland.
Sara Twaddle, Director of Evidence for Healthcare Improvement Scotland, said:
“Over 5 million people are currently being treated for asthma in the UK and 1,468 people died from asthma attacks in the UK in 2015 – the highest level for 10 years. It’s important that we diagnose and treat people to the best of our ability, hence the reason we update this guideline for clinicians every two years using the most up-to-date evidence. This new updated guideline underlines that there is still no single diagnostic test for asthma, and emphasises the importance of preventive therapy. We urge clinicians across the UK to refer to this guideline for diagnosis and treatment. By doing so, they will help to improve the care that people with asthma receive.”
The BTS/SIGN asthma guideline is a ‘living guideline’ updated biennially.  Following a scoping exercise, key sections are selected for updating based on availability of new evidence. 
Free full text:

Monday, September 19, 2016

Effects of omalizumab in severe asthmatics across ages: A real life Italian experience (article from Respiratory Medicine 2016)

Dear friends, read new article from last issue of Respiratory Medicine on effects of Omalizumab in asthmatics!


This retrospective study aimed at evaluating long-term effects of Omalizumab in elderly asthmatics in a real-life setting.


105 consecutive severe asthmatics (GINA step 4–5; mean FEV1% predicted:66 ± 15.7) treated with Omalizumab for at least 1 year (treatment mean duration 35.1 ± 21.7 months) were divided into 3 groups according to their age at Omalizumab treatment onset: 18–39, 40–64 and ≥ 65 years.


Comorbidities, number of overweight/obese subjects and patients with late-onset asthma were more frequent among older people. A similar reduction of inhaled corticosteroids dosage and SABA on-demand therapy was observed in all groups during Omalizumab treatment; a similar FEV1 increased was also observed. Asthma Control Test (ACT) improved significantly (p < 0.001) in the three groups, increasing from 15 [IQR:12-18] to 24 [IQR:22-25] in younger subjects, from 14 [IQR:10-16] to 21 [IQR:20-23] in the 40-64-year-group and from 15 [IQR:12-16] to 20 [IQR:18-22] in elderly patients where improvement was lower (p = 0.039) compared to younger people. Asthma exacerbations decreased significantly after Omalizumab but the percentage of exacerbation-free patients was higher in younger people (76.9%) compared to middle aged patients (49.2%) and the elderly (29%) (p = 0.049).
After Omalizumab treatment, the risk for exacerbations was lower in subjects aged 40–64 (OR = 0.284 [CI95% = 0.098–0.826], p = 0.021) and 18–39 (OR = 0.133 [CI95% = 0.026–0.678], p = 0.015), compared to elderly asthmatics. Also, a significantly reduced ACT improvement (β = −1.070; p = 0.046) passing from each age class was observed.


Omalizumab improves all asthma outcomes independently of age, although the magnitude of the effects observed in the elderly seems to be lower than in the other age groups.

Friday, September 16, 2016

Predicting Health-Related Quality of Life in Patients with Chronic Obstructive Pulmonary Disease: The Impact of Age (article from Respiration)

Dear Friends, we are happy to present you our new article published online yesterday in Respiration!
Background: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity in the elderly population. COPD leads to a reduced health-related quality of life (HRQL), but the factors which contribute to this are not well understood. A better understanding of the factors which determine HRQL should lead to an improved care for such patients. Objectives: The purpose of this study was to investigate possible age-related differences in HRQL in a population of patients with a similar severity of obstruction.
Methods: A total of 180 consecutive COPD patients were enrolled into the study. We analyzed spirometric data, BODE index and its components, and comorbidities were assessed by the Charlson index. HRQL was assessed by the Clinical COPD Questionnaire (CCQ) and St. George's Respiratory Questionnaire (SGRQ). Results: The cohort consisted of 93 ‘younger' patients (mean age 54.8 ± 3.1 years) and 87 older patients (mean age 73.1 ± 5.5 years). Patients in both groups had a similar severity of obstruction: FEV1 (% from predicted) was 39.9 ± 13.2% in the elderly group compared to 41.7 ± 11.7% in the younger group (p > 0.05). The forward stepwise regression analysis shows that the BODE index, the Charlson index, and the rate of exacerbations are important predictors of deterioration of HRQL in elderly COPD patients, which explains 29% of the total SGRQ score. In the younger COPD patients, the coefficient of determination R2 was 0.27, but the predictors were the BODE index and the rate of exacerbations. Conclusions: The BODE index, the Charlson index, and the rate of exacerbations were found to be the major determinants of HRQL in elderly COPD patients, while in younger COPD patients, the BODE index and the rate of exacerbations were influential factors.
Full text:

Sunday, September 11, 2016

Tiotropium formulations and safety: a network meta-analysis (paper from Therapeutic Advances in Drug Safety)

Dear friends, its new paper on safety of tiotropium from Therapeutic Advances in Drug Safety by great Italian team!
Tiotropium is now delivered via two different inhaler devices: the original Handihaler 18 μg once daily, which uses a powder formulation; and the newer Respimat Soft Mist Inhaler (SMI) 5 μg once daily. It has been questioned whether the two devices can be assumed to have the same safety profile, although the TIOSPIR trial showed that tiotropium when administered via Respimat SMI 5 μg is not less safe than Handihaler 18 μg. Therefore, we have carried out a safety evaluation of tiotropium Handihaler 18 µg versus tiotropium Respimat SMI 5 µg and 2.5 µg, via systematic review and network meta-analysis of the currently available clinical evidence. The results of our meta-analysis with an extremely large number of patients analysed demonstrate that the safety profile of tiotropium HandiHaler is generally superior to that of tiotropium Respimat SMI, although no statistical difference was detected between these two devices. However, the SUCRA analysis favoured tiotropium Respimat SMI with regards to serious adverse events (AEs). We do not believe that using Respimat SMI rather that HandiHaler exposes patients to higher risks of real AEs.
Rather, we believe that there may be a different cardiovascular (CV) response to muscarinic receptors blockage in individual patients. Therefore, it will be essential to make all possible efforts to proactively identify patients at increased risk of CV AEs when treated with tiotropium or another antimuscarinic drug. 
Full text:

Friday, August 26, 2016

Therapeutic Monoclonal Antibodies for the Treatment of COPD (article from Drugs)

Dear friends we are happy to present you new article by world known experts in Respiratory Medicine Maria Gabriella Matera, Clive Page, Paola Rogliani, Luigino Calzetta, : Therapeutic Monoclonal Antibodies for the Treatment of COPD (article from last issue of Drugs journal)!  acebook.1.SEM.ArticleAuthorAssignedToIssue
Chronic obstructive pulmonary disease (COPD) is a disorder characterized by a complex chronic inflammatory response that is largely poorly responsive to treatment with corticosteroids. Consequently, there is a huge need to find effective anti-inflammatory agents for the treatment of patients with this disease. Inhibition of cytokines and chemokines or their receptors using monoclonal antibodies (mAbs) could be a potential strategy to treat the inflammatory component of COPD. In this article, we review the therapeutic potential of some of these mAbs; however, to date there has been little or no therapeutic effect of any mAb directed against cytokines or chemokines in patients with COPD. This may reflect the complexity of COPD in which there is no dominant role for any single cytokine or chemokine. It is also likely that since the umbrella term COPD covers many endotypes having different underlying mechanisms, mAbs directed towards specific cytokines or chemokines should be tested in restricted and focused populations.
Full text:

Pleural Mesothelioma: Cancer of the Lining of the Lungs (Guest post by Katherine Keys)

Mesothelioma is a type of cancer that affects the mesothelium, a tissue that lines most of the body’s organs. The most common type is pleural mesothelioma, cancer of the pleura or lining of the lungs. This cancer is aggressive, takes years to develop into recognizable symptoms, and is often diagnosed only after it is too late to expect treatment to cure it. For most people, this terrible illness is a death sentence.
Causes and Risk Factors
Doctors and researchers cannot pinpoint an exact cause of mesothelioma, which is not a common type of cancer. It is likely an interaction of several factors that leads to the development of malignant tumors. These include genetics, environmental factors, lifestyle, and health. While the cause cannot be made definite, there is one huge risk factor for mesothelioma that stands apart from all others: asbestos exposure.
Asbestos is a natural mineral that has been used for hundreds of years in a number of applications from insulation to shipbuilding to car brakes. It has been used for so long and in so many different ways because it is very strong and resistant to heat. Because asbestos is fibrous, when it is broken apart, particles get in the air and can be inhaled.
It is this inhalation that is the number one risk factor for mesothelioma. People who worked in conditions that included asbestos fibers and inadequate safety gear are at serious risk for the cancer. It can take 20 years and more for the cancer to develop and show symptoms and too many people are surprised later in life with this terrible diagnosis.
Treatment for Mesothelioma
It is unfortunate that this type of cancer is so aggressive and often gets diagnosed in later stages; many people don’t survive and treatments may only extend a patients’ life a little longer. Still, many opt for treatments to live longer and to be more comfortable.Treatment options for pleural mesothelioma include surgery to remove the cancerous tissue or even an entire lung, chemotherapy or radiation to kill cancer cells, and clinical trials with new medications and therapies, including gene therapy.
Mesothelioma and Legal Action
Many people diagnosed with mesothelioma were exposed to asbestos at work. This especially includes people who worked on ships or in construction with asbestos insulation. Most of these workers who end up with this terrible type of cancer had no idea that they were exposed to asbestos fibers or that they were at risk. They feel wronged and many want justice.
Mesothelioma lawsuits continue to rise because of these people suffering from cancer. They are working with lawyers to sue their employers, to file claims, and to seek compensation from asbestos trust funds. Their employers failed in a responsibility to provide them with a safe workplace, and now they are getting both compensation and justice for their suffering.
A Survivor’s Story
Katherine Keys is a woman who battled the odds and won. Diagnosed with pleural mesothelioma at age 49, she was given just two years to live, even though the cancer was rated as stage 1. Determined to fight and survive, Katherine underwent surgery to remove her right lung along with its pleura. She also had radiation treatment for several months.
Katherine is in remission and is now down to only annual follow ups to make sure that the cancer has not returned. Losing a lung has been difficult and she experiences pain and certain limitations, but is happy to be alive. Her story is one that brings hope to others battling this terrible type of cancer.