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: 11.99). 11/2001; 164(8 Pt 1):1392-7.
Source: PubMed

ABSTRACT 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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    • "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.
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    • "The goal of asthma treatment, as defi ned in the recent guidelines update (GINA 2007; NAEPP 2007), is to reach and maintain asthma control, defi ned as minimal symptoms, no exacerbations, and no limitation of activities, together with normal lung function. Most studies in recent years have shown that asthma can be well controlled in most patients with inhaled steroids alone or in combination with long-acting beta2 agonists (LABA) (O'Byrne et al 2001; Bateman et al 2004; Rabe et al 2006). In contrast, epidemiological studies show that, overall, asthma is not adequately treated (and thus not controlled) in patients in the " real world, " probably because they behave differently from patients studied in randomized controlled trials: those patients are selected for their adherence to treatment and their ability to use the inhaler devices correctly. "
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    • "Short-acting b 2 -adrenoceptor agonists have been the main therapy for relief of asthma and are also used extensively in COPD. The development of the inhaled long-acting b 2 -adrenoceptor agonists (LABAs), salmeterol and formoterol, have been an important addition to maintenance therapy for asthma, particularly in the management of persistent moderate to severe asthma but also in mild asthma (O'Byrne et al., 2001). Inhaled LABAs are most effective when given in conjunction with inhaled corticosteroids (ICS), and most patients with persistent asthma now receive both classes of treatment, in accordance with international guidelines for asthma management. "
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