Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study

Juan Carlos Ivancevich Thursday, 08 December 2016 15:44



Low-dose inhaled corticosteroids (ICS) are highly effective for reducing asthma exacerbations and mortality. Conventionally, ICS treatment is recommended for patients with symptoms on more than 2 days per week, but this criterion has scant evidence. We aimed to assess the validity of the previous symptom-based cutoff for starting ICS by establishing whether there was a differential response to budesonide versus placebo for severe asthma exacerbations, lung function, and asthma symptom control across subgroups identified by baseline asthma symptom frequency.


We did a post-hoc analysis of the 3 year inhaled Steroid Treatment As Regular Therapy (START) study, done in 32 countries, with clinic visits every 3 months. Patients (aged 4–66 years) with mild asthma diagnosed within the previous 2 years and no previous regular corticosteroids were randomised to receive once daily, inhaled budesonide 400 μg (those aged <11 years 200 μg) or placebo. Coprimary outcomes for this analysis were time to first severe asthma-related event (SARE; hospital admission, emergency treatment, or death) and change from baseline in lung function after bronchodilator. Interaction with baseline symptom frequency was investigated, with patients grouped by more than two symptom days per week and two or fewer symptom days per week (divided into no days to 1 day, and more than 1 day to 2 days). Analysis was done by intention to treat.


Of 7138 patients (n=3577 budesonide; n=3561 placebo), baseline symptom frequency was 0–1 days per week for 2184 (31%) participants, more than 1 and less than or equal to 2 symptom days per week for 1914 (27%) participants, and more than 2 symptom days per week for 3040 (43%) participants. For budesonide versus placebo, time to first SARE was longer across symptom frequency subgroups (hazard ratios 0·54 [95% CI 0·34–0·86] for 0–1 symptom days per week, 0·60 [0·39–0·93] for >1 to ≤2 symptom days per week, 0·57 [0·41–0·79] >2 symptom days per week, pinteraction=0·94), and the decline in postbronchodilator lung function was less at 3 years' follow-up (pinteraction=0·32). For budesonide versus placebo, severe exacerbations requiring oral or systemic corticosteroids were reduced (rate ratio 0·48 [0·38–0·61] 0–1 symptom days per week, 0·56 [0·44–0·71] >1 to ≤2 symptom days per week, and 0·66 [0·55–0·80] >2 symptom days per week, pinteraction=0·11), prebronchodilator lung function was higher, and symptom-free days were more frequent (p<0·0001 for all three subgroups), with no interaction by symptom frequency (prebronchodilator pinteraction=0·43; symptom-free days pinteraction=0·53). Similar results were noted when participants were classified by any guidelines criterion as so-called persistent versus so-called intermittent asthma.


In mild recent-onset asthma, once daily, low-dose budesonide decreases SARE risk, reduces lung function decline, and improves symptom control similarly across all symptom subgroups. The results do not support restriction of inhaled corticosteroids to patients with symptoms on more than 2 days per week and suggest that treatment recommendations for mild asthma should consider both risk reduction and symptoms.


What are the pros and cons of electronically monitoring inhaler use in asthma? A multistakeholder perspective

Juan Carlos Ivancevich Tuesday, 06 December 2016 00:23



BMJ Open Resp Res 2016;3:e000159 doi:10.1136/bmjresp-2016-000159

+Author Affiliations

1Human Factors Research GroupInnovation and Technology Research Centre, University of NottinghamNottingham, UK 2Division of Respiratory MedicineSchool of Medicine, Nottingham City Hospital, University of NottinghamNottingham, UK


Introduction Electronic monitoring devices (EMDs) are the optimal method for collecting objective data on inhaler use in asthma. Recent research has investigated the attitudes of patients with asthma towards these devices. However, no research to date has formally considered the opinions of stakeholders and decision-makers in asthma care. These individuals have important clinical requirements that need to be taken into account if EMDs are to be successfully provisioned, making collecting their opinions on the key barriers facing these devices a valuable process.

Methods Three rounds of surveys in a Delphi format were used to assess the most important pros and cons of EMDs for asthma care in a sample of 31 stakeholders which included healthcare professionals and members of clinical commissioning groups.

Results The respondents identified 29 pros and 32 cons. Pros that were rated as most important included new visual evidence to aid clinical discussions with a patient and an increase in patient involvement and motivation. The cons that were rated as most important included a need for more clinical evidence of the effectiveness of EMDs, as well as better clarity over who has responsibilities in managing, interpreting and discussing data with a patient.

Conclusions The research provides a guide for EMD developers by highlighting where these devices may provide the most benefit as well as prioritising the key issues that need addressing if they are to be used effectively in everyday asthma care.

Propofol and Remifentanil Sedation for Bronchial Thermoplasty: A Prospective Cohort Trial

Juan Carlos Ivancevich Saturday, 26 November 2016 23:40
d'Hooghe J.N.S.a · Eberl S.b · Annema J.T.a · Bonta P.I.a 
Departments of Pulmonology and Anesthesiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands


Background: Bronchial thermoplasty (BT) is a rapidly emerging bronchoscopic treatment for patients with moderate-to-severe asthma. Different sedation strategies are currently used, ranging from mild midazolam sedation to general anesthesia requiring tracheal intubation. Objectives: The aim of this study was to assess the feasibility, safety, and both patients' and bronchoscopists' satisfaction with propofol and remifentanil sedation administered by specialized sedation anesthesiology nurses during BT in severe asthma patients. Methods: A prospective observational cohort study in BT-treated severe asthma patients of the TASMA trial was designed. Patients were asked to rate their overall BT procedure satisfaction and tolerance with propofol/remifentanil sedation using a visual analogue scale (VAS) ranging from 0 to 10. Similarly, bronchoscopists were asked to rate patient cooperation and tolerance. Sedation-associated adverse events and the number of BT activations were recorded. Results: Thirty-two BT procedures in 13 severe asthma patients were performed under moderate target-controlled infusion (TCI) propofol/remifentanil sedation. Patients' median VAS scores were as follows: overall satisfaction 9.6 (interquartile range [IQR] 8.5-10.0), dyspnea 0.0 (IQR 0.0-0.6), pain 0.1 (IQR 0.0-1.0), cough 0.5 (IQR 0.0-2.1), and anxiety 0.1 (IQR 0.0-0.7). Bronchoscopists' median VAS scores were as follows: overall patient cooperation 9.1 (IQR 8.5-9.6), dyspnea 0.3 (IQR 0.0-0.9), pain 0.2 (IQR 0.0-1.3), cough 1.2 (IQR 0.7-2.0), and discomfort 0.6 (IQR 0.3-1.5). All patients were willing to undergo the procedure again and would recommend this form of sedation to their best friend. One case of conversion to general anesthesia occurred and no serious adverse events were reported. Conclusions: Moderate sedation with propofol and remifentanil TCI provided by specialized sedation anesthesiology nurses is feasible and safe and results in high satisfaction rates of both patients and bronchoscopists.


Severe asthma: Current management, targeted therapies and future directions—A roundtable report

Juan Carlos Ivancevich Tuesday, 06 December 2016 00:09

Invited Review Series: Seeking Innovative Solutions in Severe Asthma

Authors Vanessa M. McDonald, Steven Maltby, Helen K. Reddel, Gregory G. King, Peter A.B. Wark, Lorraine Smith, John W. Upham, Alan L. James, Guy B. Marks, Peter G. Gibson


Asthma is a chronic respiratory disease characterized by respiratory symptoms, airway inflammation, airway obstruction and airway hyper-responsiveness. Asthma is common and directly affects 10% of Australians, 1–5% of adults in Asia and 300 million people worldwide. It is a heterogeneous disorder with many clinical, molecular, biological and pathophysiological phenotypes. Current management strategies successfully treat the majority of patients with asthma who have access to them. However, there is a subset of an estimated 5–10% of patients with asthma who have severe disease and are disproportionately impacted by symptoms, exacerbations and overall illness burden. The care required for this relatively small proportion of patients is also significant and has a major impact on the healthcare system. A number of new therapies that hold promise for severe asthma are currently in clinical trials or are entering the Australian and international market. However, recognition of severe asthma in clinical practice is variable, and there is little consensus on the best models of care or how to integrate emerging and often costly therapies into current practice. In this article, we report on roundtable discussions held with severe asthma experts from around Australia, and make recommendations about approaches for better patient diagnosis and assessment. We assess current models of care for patient management and discuss how approaches may be optimized to improve patient outcomes. Finally, we propose mechanisms to assess new therapies and how to best integrate these approaches into future treatment.


Association Between Allergen Exposure in Inner-City Schools and Asthma Morbidity Among Students

Juan Carlos Ivancevich Friday, 25 November 2016 21:42
Key Points

Question  What is the effect of school-specific aeroallergen exposures on students’ asthma morbidity?

Findings  In this cohort study evaluating students with asthma, higher mouse allergen exposure at school was significantly associated with both increased asthma symptoms and lower lung function, independent of allergic sensitization and allergen exposure in the home.

Meaning  The school environment is an important contributor to childhood asthma morbidity, and future school-based environmental interventions may benefit all children with asthma.


Importance  Home aeroallergen exposure is associated with increased asthma morbidity in children, yet little is known about the contribution of school aeroallergen exposures to such morbidity.

Objective  To evaluate the effect of school-specific aeroallergen exposures on asthma morbidity among students, adjusting for home exposures.

Design, Setting, and Participants  The School Inner-City Asthma Study was a prospective cohort study evaluating 284 students aged 4 to 13 years with asthma who were enrolled from 37 inner-city elementary schools in the northeastern United States between March 1, 2008, and August 31, 2013. Enrolled students underwent baseline clinical evaluations before the school year started and were then observed clinically for 1 year. During that same school year, classroom and home dust samples linked to the students were collected and analyzed for common indoor aeroallergens. Associations between school aeroallergen exposure and asthma outcomes during the school year were assessed, adjusting for home exposures.

Exposures  Indoor aeroallergens, including rat, mouse, cockroach, cat, dog, and dust mites, measured in dust samples collected from inner-city schools.

Main Outcomes and Measures  The primary outcome was maximum days in the past 2 weeks with asthma symptoms. Secondary outcomes included well-established markers of asthma morbidity, including asthma-associated health care use and lung function, measured by forced expiratory volume in 1 second.

Results  Among 284 students (median age, 8 years [interquartile range, 6-9 years]; 148 boys and 136 girls), exposure to mouse allergen was detected in 441 (99.5%) of 443 school dust samples, cat allergen in 420 samples (94.8%), and dog allergen in 366 samples (82.6%). Levels of mouse allergen in schools were significantly higher than in students’ homes (median settled dust level, 0.90 vs 0.14 µg/g; P < .001). Exposure to higher levels of mouse allergen in school (comparing 75th with 25th percentile) was associated with increased odds of having an asthma symptom day (odds ratio, 1.27; 95% CI, 1.05-1.54; P = .02) and 4.0 percentage points lower predicted forced expiratory volume in 1 second (95% CI, –6.6 to –1.5; P = .002). This effect was independent of allergic sensitization. None of the other indoor aeroallergens were associated with worsening asthma outcomes.

Conclusions and Relevance  In this study of inner-city students with asthma, exposure to mouse allergen in schools was associated with increased asthma symptoms and decreased lung function. These findings demonstrate that the school environment is an important contributor to childhood asthma morbidity. Future school-based environmental interventions may be beneficial for this important public health problem.

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