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.

34 Reads
  • Source
    • "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]. "
    [Show abstract] [Hide abstract]
    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.
    European Journal of Internal Medicine 10/2014; 25(8). DOI:10.1016/j.ejim.2014.06.022 · 2.89 Impact Factor
  • Source
    • "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). "
    [Show abstract] [Hide abstract]
    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.
    SpringerPlus 12/2013; 2(1):82. DOI:10.1186/2193-1801-2-82
  • Source
    • "The START study investigated 5000 patients over a 3-year period and showed a marked reduction in exacerbation rate with small improvement in lung function.[13] Moreover, the OPTIMA study showed reduced exacerbation rate and improvement in lung function in patients who received regular inhaled steroids.[14] A recently published study by Reddel et al. showed the beneficial effects of regular inhaled steroid therapy in asthmatic patients.[15] "
    [Show abstract] [Hide abstract]
    ABSTRACT: Routine protocol of asthma treatment has been focused on symptom suppression but severity of inflammation and spirometry findings may be neglected. We investigated the efficacy of full dose treatment protocol on patients with mild asthma symptoms with normal spirometry. A before-after clinical trial study was conducted on patients with asthma symptoms (dyspnea, cough, and wheezing), while they had a near to normal pulmonary function test. Full dose treatment protocol (prednisolone 1 mg/kg for 5 days then fluticasone spray 250 mg four puffs daily plus salmeterol spray 25 mg four puffs daily), which was routinely used for severe asthma, was administrated and patients were followed up for 2 months. Sixty-eight patients (mean age (±SD) = 43.77 ± 10.70 years, female/male ratio; 47/53%) finally finished the study. At the baseline, mean forced expiratory volume in first second (FEV1) and forced vital capacity (FVC) were 91 ± 12% and 87 ± 11% of the predicted value, respectively. Two months after treatment, the mean FEV1 and FVC were 105 ± 14% and 97 ± 10%, respectively, which both improved compared with the baseline, significantly (P < 0.001). Frequencies of cough and dyspnea were significantly decreased (P = 0.041 and 0.034, respectively). Our result declared that full dose treatment can improve spirometry amounts and frequency of symptoms in patients with near to normal spirometry and obvious asthmatic symptoms. Routine treatment protocol of mild asthma recommends sole short-acting b2 receptor agonist, but it seems that pulmonary function and volume can be increased with more aggressive treatment.
    Journal of research in medical sciences 11/2013; 18(11):929-33. · 0.65 Impact Factor
Show more