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Combination of budesonide/formoterol on demand improves asthma control by reducing exercise-induced bronchoconstriction

Background

In mild asthma exercise-induced bronchoconstriction (EIB) is usually treated with inhaled short-acting β2 agonists (SABAs) on demand.

 Objective

The hypothesis was that a combination of budesonide and formoterol on demand diminishes EIB equally to regular inhalation of budesonide and is more effective than terbutaline inhaled on demand.

 Methods

Sixty-six patients with asthma (>12 years of age) with verified EIB were randomised to terbutaline (0.5 mg) on demand, regular budesonide (400 μg) and terbutaline (0.5 mg) on demand, or a combination of budesonide (200 μg) + formoterol (6 μg) on demand in a 6-week, double-blind, parallel-group study (ClinicalTrials.gov identifier: NCT00989833). The patients were instructed to perform three to four working sessions per week. The main outcome was EIB 24 h after the last dosing of study medication.

 Results

After 6 weeks of treatment with regular budesonide or budesonide+formoterol on demand the maximum post-exercise forced expiratory volume in 1 s fall, 24 h after the last medication, was 6.6% (mean; 95% CI –10.3 to –3.0) and 5.4% (–8.9 to –1.8) smaller, respectively. This effect was superior to inhalation of terbutaline on demand (+1.5%; –2.1 to +5.1). The total budesonide dose was approximately 2.5 times lower in the budesonide+formoterol group than in the regular budesonide group. The need for extra medication was similar in the three groups.

 Conclusions

The combination of budesonide and formoterol on demand improves asthma control by reducing EIB in the same order of magnitude as regular budesonide treatment despite a substantially lower total steroid dose. Both these treatments were superior to terbutaline on demand, which did not alter the bronchial response to exercise. The results question the recommendation of prescribing SABAs as the only treatment for EIB in mild asthma.

Changes in right heart haemodynamics and echocardiographic function in an advanced phenotype of pulmonary hypertension and right heart dysfunction associated with pulmonary fibrosis

Background

Pulmonary hypertension (PH)-targeted therapy in the setting of pulmonary fibrosis (PF) is controversial; the main clinical concern is worsening of systemic hypoxaemia. We sought to determine the effects of gentle initiation and chronic administration of parenteral treprostinil on right heart function in patients with PF associated with an advanced PH phenotype.

 Methods

Open-label, prospective analysis of patients with PF-PH referred for lung transplantation (LT). Advanced PH was defined as mean pulmonary artery pressure (mPAP) ≥35 mm Hg. We compared haemodynamics, Doppler echocardiography (DE), oxygenation, dyspnoea and quality of life indices, and 6 min walk distance (6MWD) before and 12 weeks after parenteral treprostinil.

 Results

15 patients were recruited in the study. After therapy, there were significant improvements in right heart haemodynamics (right atrial pressure (9.5 ± 3.4 vs 6.0 ± 3.7); mPAP (47 ± 8 vs 38.9 ± 13.4); CI (2.3 ± 0.5 vs 2.7 ± 0.6); pulmonary vascular resistance (698 ± 278 vs 496 ± 229); transpulmonary gradient (34.7 ± 8.7 vs 28.5 ± 10.3); mvO2 (65 ± 7.2 vs 70.9 ± 7.4); and stroke volume index (29.2 ± 6.7 vs 33 ± 7.3)) and DE parameters reflecting right heart function (right ventricular (RV) end diastolic area (36.4 ± 5.2 vs 30.9 ± 8.2 cm2), left ventricular eccentricity index (1.7 ± 0.6 vs 1.3 ± 0.5), tricuspid annular planar systolic excursion (1.6 ± 0.5 vs 1.9 ± 0.2 cm)). These changes occurred without significant alteration in systemic oxygenation, heart rate, or mean systemic arterial pressure. In addition, improvements were seen in 6MWD (171 ± 93 vs 230 ± 114), 36-Item Short Form Health Survey Mental Component Summary aggregate (38 ± 11 vs 44.2 ± 10.7), University of California, San Diego Shortness of Breath Questionnaire (87 ± 17.1 vs 73.1 ± 21), and brain natriuretic peptide (558 ± 859 vs 228 ± 340).

 Conclusions

PH-targeted therapy may improve right heart haemodynamics and echocardiographic function without affecting systemic oxygen saturation in an advanced PH phenotype associated with RV dysfunction in the setting of PF.

Erythromycin to prevent exacerbations of bronchiectasis

The purpose of this study was to evaluate whether low-dose erythromycin would reduce pulmonary exacerbations in patients with non-cystic fibrosis (CF) brocnchiectasis with a history of frequent exacerbations. In comparison to previously published work using azithromycin prophylaxis, a prolonged period of 12 months was used for evaluation and there were attempts to more precisely quantify the bacterial resistance associated with prolonged macrolide use.

In this randomised, double-blind, placebo-controlled trial, 679 patients were screened with 117 randomised after the exclusion criteria were applied. A total of 107 completed the study. Reasons for exclusion included no high-resolution CT confirmed bronchiectasis and insufficient pre-trial exacerbations. Fifty-nine individuals were randomised to the erythromycin group (oral erythromycin ethylsuccinate 400 mg twice daily) and 58 to the placebo group.

There was a significant reduction in ‘protocol defined pulmonary exacerbations’ in the erythromycin group. In the pre-specified subgroup of patients with baseline Pseudomonas aeruginosa airway infection, again there...

Thrombolysis for acute submassive pulmonary embolism: CON viewpoint

The normotensive patient with confirmed pulmonary embolism (PE) and right ventricular (RV) dilatation presents a significant dilemma to clinicians. On one hand, a string of publications have demonstrated that RV dysfunction is associated with adverse outcomes in patients with PE;1–5 on the other, thrombolysis carries a significant risk of bleeding.6 7 However, evidence emerging in recent years has provided a strong case against using thrombolysis in this setting, greatly aiding clinical decision-making in submassive PE (taken here to mean confirmed PE in a normotensive patient with evidence of RV dilatation and/or RV dysfunction and/or pulmonary hypertension). The aim of this article is to review some of the most important data surrounding this debate.

The decision to administer systemic thrombolysis would be easier if submassive PE had a high mortality rate that was significantly reduced...

Surgery in the treatment of malignant pleural mesothelioma: recruitment into trials should be the default position

Background

Europe is at the peak of an epidemic of malignant pleural mesothelioma and the burden of disease is likely to continue rising in the large areas of the world where asbestos remains unregulated. Patients with mesothelioma present with thoracic symptoms and radiological changes so respiratory physicians take a leading role in diagnosis and management. Belief that the modest survival times reported after radical surgery, whether alone or as part of multimodal therapy, are longer than they it would have been without surgery relies on data from highly selected, uncontrolled, retrospectively analysed case series. The only randomised study, the Mesothelioma and Radical Surgery (MARS) trial showed no benefit. A simple modelling study of registry patients, described here, shows that an impression of longer survival is eroded when patients who were never candidates for operation on grounds of histology, performance status and age are sequentially excluded from the model.

 Conclusion

Whenever the question arises `Might an operation help me?' there are two responses that can and should be given. The first is that there is doubt about whether there is any survival or symptomatic benefit from surgery but we know that there is harm. The second is that there are on-going studies, including two randomised trials, which patients should be informed about. The authors suggest that the default position for clinicians should be to encourage recruitment into these trials.

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