Low Dose Inhaled Budesonide and Formoterol in Mild Persistent Asthma . The OPTIMA Randomized Trial

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
American Journal of Respiratory and Critical Care Medicine (Impact Factor: 13). 11/2001; 164(8 Pt 1):1392-7.
Source: PubMed


The optimal treatment for mild asthma is uncertain. We assessed the effects of adding a long-acting inhaled beta-agonist, formoterol, to low doses of an inhaled corticosteroid, budesonide, for 1 yr in subjects with mild asthma, receiving no or only a small dose of inhaled corticosteroid. The 698 corticosteroid free patients (Group A) were assigned to twice daily treatment with 100 microg budesonide, 100 microg budesonide plus 4.5 microg formoterol, or placebo. The 1,272 corticosteroid-treated patients (Group B) were assigned to twice daily treatment with 100 microg budesonide, 100 microg budesonide plus 4.5 microg formoterol, 200 microg budesonide, or 200 microg budesonide plus 4.5 microg formoterol. The main outcome variables were time to the first severe asthma exacerbation and poorly controlled asthma days. In Group A, budesonide alone reduced the risk for severe exacerbations by 60% and poorly controlled days by 48%; adding formoterol increased lung function with no change in other end points. By contrast, in Group B, adding formoterol reduced the risk for the first severe exacerbation and for poorly controlled days by 43 and 30%, respectively. Thus, in corticosteroid-free patients, low dose inhaled budesonide alone reduced severe exacerbations and improved asthma control, and in patients already receiving inhaled corticosteroid, adding formoterol was more effective than doubling the corticosteroid dose.

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    • "Inhaled corticosteroid (ICS) is a mainstay in the pharmacotherapy for asthma, as chronic airway inflammation is a key feature of the disease[5]. ICS improves symptom control, quality of life, lung function, exacerbation risk and asthma-related mortality78910. Considering many different immune cells involved in asthma pathogenesis, it may be natural that broad anti-inflammatory effects of corticosteroids offer more therapeutic gain than more specific anti-inflammatory drugs. As ICS largely targets eosinophilic inflammation, the effects could vary with inflammatory profiles of asthma patients. "
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    ABSTRACT: Asthma in the elderly is a disease with emerging concern. Despite some recent advances in our understanding of epidemiology and pathophysiology, there is a considerable lack of clinical evidence specific to elderly patients. Currently available high quality clinical evidence has been mostly obtained from younger adults, but rarely from elderly patients. Under-representation of elderly patients in previous randomized trials may have been due to being, old age, or having comorbidities. Thus, a question may be raised whether current clinical evidence could be well generalized into elderly patients. Further clinical trials should address clinical issues raised in elderly population. In this review, we aimed to overview the efficacy and safety of pharmacological management, and also to summarize the literature relevant to elderly asthma.
    Full-text · Article · Feb 2016
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    • "The results of numerous randomized and controlled clinical studies have demonstrated the efficacy of using ICS/LABA (an inhaled corticosteroid combined with a long-acting inhaled β 2 -agonist) in a single inhaler for the treatment of asthma of patients not controlled by low doses of inhaled steroids [21] [22] [23] [24] [25] [26]. Moreover, it has been shown that the combination of these drugs considerably improved the management of asthma symptoms, including mild and severe exacerbations, as compared with the administration of ICS as monotherapy [27] [28]. "
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    ABSTRACT: International guidelines describe asthma control as the main outcome of asthma management. Prevention of symptoms, improved quality of life, and reduction of exacerbations are the main components, consequently decreasing health care costs. However, many of these objectives remain unmet in real life: several surveys show that a large proportion of asthmatic patients are not well controlled despite the efficacy of current available treatment. Several randomized controlled clinical trials indicate that combining inhaled corticosteroids and long-acting β2-agonists, by means of a single inhaler, greatly improves the management of the disease. The results of 9 multicenter phase III clinical studies demonstrate that the fixed combination of fluticasone propionate/formoterol in a single inhaler is effective in terms of lung function and symptom control. These studies highlight the dose flexibility, safety and tolerability of this new inhaled combination. These characteristics meet the recommendations of international guidelines, and the preferences of respiratory physicians who identified these aspects as critical components of a successful asthma therapy. Combination of fluticasone propionate/formoterol in a single inhaler provides potent anti-inflammatory activity of fluticasone propionate and rapid onset of action of the β2-agonist formoterol making this association a viable treatment option both in terms of effectiveness and compliance.
    Full-text · Article · Oct 2014 · European Journal of Internal Medicine
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    • "The economic analysis of published clinical trials using inhaled Glucocorticosteroids shows an increase in the cost of drugs and, in some cases, the total costs of asthma management, but their use results in better control of exacerbations and of other symptoms (Shrewsbury et al. 2000, Pauwels et al. 1997, O’Byrne et al. 2001, Greening et al. 1994). "
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    ABSTRACT: Asthma is a big public health problem in Morocco. The drug therapy existing in Morocco is currently insufficient because of the low purchasing power and the low health insurance coverage available to the average citizen in Morocco. In this study we evaluated the consumption of antiasthmatics in Morocco during the period 1999-2010, the classes of used drugs and the generics' market share. We used sales data from the Moroccan subsidiaries of the IMS Health "Intercontinental Marketing Service". The consumption volume was converted to Defined Daily Doses (DDDs). During 1999-2010, antiasthmatics's consumption increased from 3.91 to 14.47 DDD per 1000 inhabitants per day. In 2010, the association Beta-2-mimetic-Glucocorticosteroids were the most consumed (8.53 DDD/1000 Inhabitants/day) followed by the short-acting inhaled Beta-2-mimetic (4 DDD/1000 Inhabitants/day) and inhaled Glucocorticosteroids alone accounted for 1.13 DDD/1000 Inhabitants/day. The largest consumption share in volume was held by the short-acting inhaled Beta-2-mimetic (42%) followed by the combination Beta-2-mimetic-Glucocorticosteroids (38%). Between 1999 and 2010, the market for generic antiasthmatics increased from 1.84 to 2.18 DDD/1000 Inhabitants/day. The ratio of the monthly average cost of treatment to the minimum wage in Morocco decreased from 10.8% in 1999 to 7.11% in 2010. Antiasthmatics' consumption in Morocco has undergone significant changes between 1999 and 2010. However, the availability of these drugs expressed as the Average Monthly Expenditure/Guaranteed Minimum Wage ratio improved. Despite this, the use of antiasmathics in Morocco remains low.
    Full-text · Article · Dec 2013 · SpringerPlus
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