Overall asthma control achieved with budesonide/formoterol maintenance and reliever therapy for patients on different treatment steps (original) (raw)
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BMC Pulmonary Medicine, 2013
Background: The use of budesonide/formoterol in a single inhaler for both maintenance and reliever therapy is a recommended option for treatment of persistent asthma not responding well to inhaled corticosteroid (ICS) alone. Methods: This was a multi-centre open-label study on patients whose asthma condition remained inadequately controlled by various asthma treatments other than budesonide/formoterol. After a 2-week run-in period, eligible patients underwent a 12-week treatment period with budesonide/formoterol (Symbicort SMART W , 160/4.5 μg) twice daily plus as needed. Patient's asthma control and quality of life were assessed using the 5-item Asthma Control Questionnaire (ACQ-5) and the standardized Asthma Quality of Life Questionnaire (AQLQ-S), respectively.
Trials, 2017
In many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation, with poor control of asthma symptoms and increased risk of exacerbations. The use of budesonide/formoterol 'as needed' in response to symptoms may represent an alternative treatment option for patients with mild asthma. The SYmbicort Given as needed in Mild Asthma (SYGMA) programme consists of two 52-week, double-blind, randomised, multicentre, parallel-group, phase 3 trials of patients aged 12 years and older with a clinical diagnosis of asthma for at least 6 months, who would qualify for treatment with regular inhaled corticosteroids (ICS). SYGMA1 aims to recruit 3750 patients who will be randomised to placebo twice daily (bid) plus as-needed budesonide/formoterol 160/4.5 μ...
The Lancet, 2019
Background In adults with mild asthma, a combination of an inhaled corticosteroid with a fast-onset long-acting β-agonist (LABA) used as reliever monotherapy reduces severe exacerbations compared with short-acting β-agonist (SABA) reliever therapy. We investigated the efficacy of combination budesonide-formoterol reliever therapy compared with maintenance budesonide plus as-needed terbutaline. Methods We did a 52-week, open-label, parallel-group, multicentre, superiority, randomised controlled trial at 15 primary care or hospital-based clinical trials units and primary care practices in New Zealand. Participants were adults aged 18-75 years with a self-reported doctor's diagnosis of asthma who were using SABA for symptom relief with or without maintenance low to moderate doses of inhaled corticosteroids in the previous 12 weeks. We randomly assigned participants (1:1) to either reliever therapy with budesonide 200 μg-formoterol 6 μg Turbuhaler (one inhalation as needed for relief of symptoms) or maintenance budesonide 200 µg Turbuhaler (one inhalation twice daily) plus terbutaline 250 µg Turbuhaler (two inhalations as needed). Participants and investigators were not masked to group assignment; the statistician was masked for analysis of the primary outcome. Six study visits were scheduled: randomisation, and weeks 4, 16, 28, 40, and 52. The primary outcome was the number of severe exacerbations per patient per year analysed by intention to treat (severe exacerbations defined as use of systemic corticosteroids for at least 3 days because of asthma, or admission to hospital or an emergency department visit because of asthma requiring systemic corticosteroids). Safety analyses included all participants who had received at least one dose of study treatment. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12616000377437. Findings Between May 4, 2016, and Dec 22, 2017, we assigned 890 participants to treatment and included 885 eligible participants in the analysis: 437 assigned to budesonide-formoterol as needed and 448 to budesonide maintenance plus terbutaline as needed. Severe exacerbations per patient per year were lower with as-needed budesonide-formoterol than with maintenance budesonide plus terbutaline as needed (absolute rate per patient per year 0•119 vs 0•172; relative rate 0•69, 95% CI 0•48-1•00; p=0•049). Nasopharyngitis was the most common adverse event in both groups, occurring in 154 (35%) of 440 patients receiving as-needed budesonide-formoterol and 144 (32%) of 448 receiving maintenance budesonide plus terbutaline as needed. Interpretation In adults with mild to moderate asthma, budesonide-formoterol used as needed for symptom relief was more effective at preventing severe exacerbations than maintenance low-dose budesonide plus as-needed terbutaline. The findings support the 2019 Global Initiative for Asthma recommendation that inhaled corticosteroid-formoterol reliever therapy is an alternative regimen to daily low-dose inhaled corticosteroid for patients with mild asthma.
The Lancet Respiratory Medicine, 2014
Background. Treatment guidelines recommend regular inhaled corticosteroid and long-acting β 2 agonist combination plus PRN rapid-acting bronchodilators for patients with moderate persistent asthma. We investigated whether PRN symptom-driven budesonide/formoterol combination would be as effective as regular budesonide/formoterol combination plus PRN symptom-driven terbutaline. Methods. After a six-week run-in period of regular budesonide/formoterol plus PRN terbutaline, 866 patients with stable moderate asthma were randomly assigned according to a list prepared with the use of a random-number generator and a balanced-block design stratified according to centre to receive placebo twice daily plus PRN combination of 160 µg budesonide/4•5 µg formoterol (PRN budesonide/formoterol therapy) or twice-daily 160 µg budesonide/4•5 µg formoterol combination plus symptom-driven 500 µg terbutaline (regular budesonide/formoterol therapy) for one year. The primary outcome was time to first treatment failure during the one year treatment, and the power of the study was calculated on the rate of treatment failure, and the analysis was performed on the intention to treat population. Findings. Compared to regular budesonide/formoterol therapy, PRN budesonide/formoterol therapy was associated with lower probability of patients with no treatment failure (Kaplan Meier estimates, 53•6% vs 64•0%; difference: 10•3%, 95% CI: 3•2%, 17•4%, pre-defined non-inferiority limit: 9%); earlier treatment failure (first quartile, 11•86 versus 28•00 days); higher drop-out rates (Kaplan Meier estimates, 34•0% vs 25•9%, p=0•009).The difference in treatment failures was largely due to nocturnal awakenings (82 patients in the PRN budesonide/formoterol group and 44 in the regular budesonide/formoterol group). PRN budesonide/formoterol therapy was also inferior in most secondary outcomes. Both treatment regimens were well tolerated. Interpretation. In patients with moderate asthma, PRN budesonide/formoterol therapy is less effective than the guidelines-recommended regular budesonide/formoterol therapy, even if the differences are small. (ClinicalTrials.gov number NCT00849095). 3 Funding: The study was granted by the Italian Medicines Agency, AIFA, (grant FARM6BWSF9). Drugs were donated by AstraZeneca.
2012
Evaluation of the efficacy and safety of a fixed-dose, single-capsule budesonide-formoterol combination in uncontrolled asthma: a randomized, double-blind, multicenter, controlled clinical trial* Avaliação da eficácia e segurança da associação de budesonida e formoterol em dose fixa e cápsula única no tratamento de asma não controlada: ensaio clínico randomizado, duplo-cego, multicêntrico e controlado
International Journal of …, 2012
BackgroundConventionally, a nebulized short-acting β-2 agonist like salbutamol is often used as the reliever in acute exacerbations of asthma. However, recent worldwide respiratory outbreaks discourage routine use of nebulization. Previous studies have shown that combined budesonide/formoterol (Symbicort®, AstraZeneca) is effective as both a maintenance and reliever anti-asthmatic medication.MethodsWe performed a randomized, open-label study from March until August 2011 to compare the bronchodilatory effects of Symbicort® vs. nebulized salbutamol in acute exacerbation of mild to moderate asthmatic attack in an emergency department. Initial objective parameters measured include the oxygen saturation, peak expiratory flow rate (PEFR) and respiratory rate. During clinical reassessment, subjective parameters [i.e., Visual Analog Scale (VAS) and 5-point Likert scale of breathlessness] and the second reading of the objective parameters were measured. For the 5-point Likert scale, the pati...