BackgroundPoor adherence with inhaled corticosteroids is an important problem in asthma management. Previous approaches to improving adherence have had limited success. AimTo determine whether treatment with a single inhaler containing a long-acting β 2 -agonist and a corticosteroid for maintenance treatment and symptom relief can overcome the problem of poor adherence with inhaled corticosteroids. Design of studyRandomised, parallel group, open-label trial. SettingForty-four general practices in Nottinghamshire. MethodParticipants who used less than 70% of their prescribed dose of inhaled corticosteroid and had poorly controlled asthma were randomised to budesonide 200 µg one puff twice daily plus their own short-acting β 2 -agonist as required (control group), or budesonide/formoterol 200/6 µg one puff once daily and as required (active group) for 6 months. The primary outcome was inhaled corticosteroid dose. ResultsSeventy-one participants (35 control, 36 active group) were randomised. Adherence with budesonide in the control group was approximately 60% of the prescribed dose. Participants in the active group used approximately 80% more budesonide than participants in the control group (448 versus 252 µg/day, mean difference 196 µg, 95% confidence interval 113 to 279; P<0.001) and were less likely to withdraw from the study (3 versus 13; P<0.01). No safety issues were identified. ConclusionUsing a single inhaler for both maintenance treatment and symptom relief approximately doubled the dose of inhaled corticosteroid taken, suggesting this could be a useful strategy to overcome the problems related to poor adherence with inhaled corticosteroids.
AimsWe have previously shown that the systemic exposure to inhaled fluticasone propionate (FP) is reduced in asthmatics compared with healthy subjects. We have now compared its pharmacokinetics in patients suffering from chronic obstructive pulmonary disease (COPD, n = 10) and matched healthy subjects ( n = 13). Methods A double-blind, randomized, cross-over study design was used. Plasma FP and serum cortisol were measured for 12 h after subjects received hydrofluoroalkane FP 1000 m g day -1 inhaled (via an MDI and spacer) for 7 days and following a single 1000-m g intravenous dose.Results The pharmacokinetics differed in the two groups. After inhalation, geometric least square means were significantly lower in the COPD group for the plasma AUC (1961 vs 2996 pg ml -1 h -1 for COPD and controls, respectively; P = 0.03) and the C max (235 vs 421 pg ml -1 for COPD and controls, respectively; P = 0.03). Suppression of serum cortisol concentration over 12 h was greater in healthy controls. Weighted mean serum cortisol concentration (nmol l -1 ) in healthy subjects and COPD was 93 and 170, respectively ( P = 0.03). The intravenous pharmacokinetic parameters for FP were comparable in the two groups, resulting in similar suppression of serum cortisol. Conclusions We conclude that the altered pharmacokinetics of inhaled fluticasone propionate in COPD caused less hypothalamic-pituitary-adrenal suppression than in healthy controls. This is further evidence that the systemic effects of inhaled corticosteroids should be assessed in patients and not healthy subjects.
The two inhaled long-acting beta2-adrenoceptor agonists, salmeterol and formoterol, have been studied extensively since their introduction in the early 1990s. In this review we consider the evidence for their efficacy and safety in adults with asthma and chronic obstructive pulmonary disease (COPD), by reviewing long-term prospective studies in which these drugs have been compared with placebo or an alternative bronchodilator. We have also assessed safety, including data from postmarketing surveillance studies and case-control studies using large databases. In patients with asthma, salmeterol and formoterol increase lung function, reduce asthmatic symptoms and improve quality of life when compared with placebo. Both drugs protect against exercise-induced asthma, although some tolerance develops with regular use. Tolerance to the bronchodilator effects of formoterol has also been seen, although this is small and most of the beneficial effects are maintained long-term. Both drugs have been shown to reduce asthma exacerbations but only in studies in which most patients were taking an inhaled corticosteroid. Adding a long-acting beta2-agonist provided better control than increasing the dose of inhaled corticosteroid in several studies. Long-acting beta2-agonists also provide better asthma control than use of regular short-acting beta2-agonists and theophylline. Their relative efficacy compared with leukotriene antagonists is uncertain as yet. Formoterol appears to be at least as safe and effective as a short-acting beta2-agonist when used on an 'as required' basis. In patients with COPD, both salmeterol and formoterol offer improved lung function and reduced COPD symptoms compared with placebo, and quality of life has been improved in some studies. Some tolerance to the bronchodilating effect of salmeterol was seen in one study. Most studies have not found a significant reduction in exacerbations in COPD. Both drugs have provided greater benefit than ipratropium bromide or theophylline; there are limited data on tiotropium bromide. The long-acting beta2-agonists cause predictable adverse effects including headache, tremor, palpitations, muscle cramps and a fall in serum potassium concentration. Salmeterol can also cause paradoxical bronchospasm. There is some evidence that serious adverse events including dysrhythmias and life-threatening asthma episodes can occur; however, the incidence of such events is very low but may be increased in patients not taking an inhaled corticosteroid. Salmeterol 50 microg twice daily and formoterol 12 microg twice daily are effective and safe in treating patients with asthma and COPD. Higher doses cause more adverse effects, although serious adverse events are rare.
30. McConnell R, Berhane K, Yao L, et al. Traffic, susceptibility, and childhood asthma. Environ Health Perspect 2006;114:766-
Background: Exacerbation of chronic obstructive pulmonary disease (COPD) is a common reason for hospital admission, and adjunctive non-pharmacological treatments would be welcomed. A pilot study was undertaken to assess the feasibility of conducting a study of acupuncture during an acute exacerbation of COPD. We also examined the credibility of a sham device in this setting and assessed the effect of acupuncture on breathlessness and anxiety.
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• The long-acting inhaled b2-agonist formoterol has systemic effects when taken in high doses.• It can be used as relief medication in asthma and there is interest in this approach in chronic obstructive pulmonary disease (COPD).• Relief medication can involve high doses, and in subjects with COPD who have limited ability to bronchodilate the adverse effects can outweigh the benefits.• There are concerns with the overall safety of high-dose b2-agonists in subjects with COPD, and this study looks at the balance of beneficial and adverse effects of a range of doses of inhaled formoterol. WHAT THIS STUDY ADDS• Among subjects with COPD, high-dose inhaled formoterol produced a dose-related increase in forced expiratory volume in 1 s without a corresponding reduction in dyspnoea or increase in walk distance.• Systemic effects were modest, however, and high doses did not appear to reduce patient satisfaction.• Although further safety data are needed, inhaled formoterol may have a role as relief medication in COPD. AIMSRac-formoterol is effective as maintenance treatment for both asthma and chronic obstructive pulmonary disease (COPD) and is now used as relief therapy in asthma. Using rac-formoterol for relief and maintenance treatment could involve inhalation of high doses, and whether this is of benefit in COPD is uncertain. Our aim was to determine whether higher doses of inhaled rac-formoterol produce systemic adverse effects that outweigh the limited bronchodilator benefit seen in subjects with COPD. METHODSWe examined airway and systemic effects of 6, 12, 24 and 48 mg rac-formoterol and placebo on separate days in 20 subjects with symptomatic COPD [forced expiratory volume in 1 s (FEV1) 47% predicted]. FEV1, oxygen saturation, dyspnoea, 6-min walk distance, patient satisfaction and systemic effects were measured and treatment was assessed against placebo and for dose-response effects. RESULTS FEV1[area under the time-response curve (AUC)] and satisfaction scores increased with all formoterol doses compared with placebo, as did AUC tremor with the 24-and 48-mg doses and AUC heart rate with the 48-mg dose. A dose-response relationship was seen with FEV1 and tremor, but not with satisfaction scores. There was no difference between placebo and rac-formoterol for other variables. CONCLUSIONSOur results show that in patients with COPD rac-formoterol improves FEV1 and patient satisfaction without a corresponding reduction in dyspnoea. Since the systemic effects from a relatively high dose were minimal, its use as relief medication in COPD merits further evaluation.
Miss H was born in 1982 and diagnosed with asthma at the age of 7 years. In 2004 she presented with cough and wheeze, a peak flow of 55% predicted, an eosinophil count of 3.75 × 109/litre (normal range 0−0.4 × 109/litre) and a normal chest radiograph. In the preceding year, she attended the accident and emergency department twice and required six courses of prednisolone, despite taking low-dose inhaled steroids on a regular basis. A smoker, she lived in a rented room and was not registered with a doctor. Following standard treatment, she was prescribed an inhaled corticosteroid and long-acting β2-agonist. She took discharge against medical advice and failed to attend follow-up clinic. Two months later she was admitted with increasing wheeze and breathlessness, but refused investigations. During this admission, but only after direct questioning, she admitted to smoking heroin. She was discharged with community drug liaison service follow-up and abstained from heroin until she attended clinic 6 weeks later. At this point she had no symptoms and a supranormal peak flow. In February 2005, she become wheezy after inhaling heroin and was admitted overnight. She took her own discharge before seeing the hospital drug liaison team and again refused investigation. Admissions followed in June, July and August 2005, with life-threatening features on the last occasion, when she narrowly avoided ventilation. During this admission she recognized that exacerbations always followed heroin inhalation and she was referred to a direct access clinic to commence oral buprenorphine (Subutex, Schering-Plough, NJ, USA), a partial opioid antagonist.
Acupuncture was used to treat a 60–year old woman with unexplained sweating associated with inoperable lung cancer that prevented her from sharing a bed with her husband. Other measures failed to improve her sweating, but she responded well to a course of acupuncture allowing her to continue sharing the marital bed.
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