"As-needed Budesonide–Formoterol in Mild Asthma". The New England Journal of Medicine. 2019.
Links to original sources: Wiki Journal Post Full Journal Article
In adults with mild asthma, is as-needed budesonide–formoterol more effective than as-needed albuterol and budesonide maintenance therapy plus as-needed albuterol in preventing asthma exacerbations?
In adults with mild asthma, as-needed budesonide–formoterol reduced the rate of asthma exacerbations compared with as-needed albuterol and was superior to both as-needed albuterol and budesonide maintenance therapy plus as-needed albuterol in reducing the risk of severe exacerbations.
This 52-week, open-label, randomized, parallel-group, controlled trial assessed the efficacy of as-needed budesonide–formoterol in mild asthma. Among patients previously taking only a short-acting β2-agonist (SABA), those using as-needed budesonide–formoterol had lower rates of asthma exacerbations than those using albuterol alone. The risk of severe exacerbation was also lower with as-needed budesonide–formoterol compared to both albuterol alone and budesonide maintenance therapy with as-needed albuterol. These results suggest that budesonide–formoterol as-needed therapy has a role in asthma management without the need for regular maintenance therapy.
No information provided regarding guidelines.
- Multicenter, randomized, open-label, parallel-group, controlled trial - N=668 adults with mild asthma - Interventions: 1. Albuterol as needed (n=224) 2. Budesonide maintenance plus as-needed albuterol (n=222) 3. As-needed budesonide–formoterol (n=222) - Duration: 52 weeks - Primary outcome: Annualized rate of asthma exacerbations
- Inclusion Criteria: Adults aged 18-75 with a doctor’s diagnosis of asthma, using only a SABA in the previous three months. - Age: Mean 44.8 years - Female: 66% - Smoking history: 10.8%
- Patients were randomly assigned to one of three groups in a 1:1:1 ratio. - Albuterol group received 100 μg as needed for symptoms. - Budesonide maintenance group received budesonide 200 μg inhalation twice daily plus as-needed albuterol. - Budesonide–formoterol group received 200 μg budesonide and 6 μg formoterol as needed for symptoms.
- Primary Outcomes: The annualized exacerbation rate was lower in the budesonide–formoterol group compared to the albuterol group (0.195 vs. 0.400 per patient-year). There was no significant difference between the budesonide–formoterol and budesonide maintenance groups. - Secondary Outcomes: The number of severe exacerbations was lower in the budesonide–formoterol group than in the other two groups. - Other Observations: Budesonide maintenance treatment provided better control of asthma symptoms. - Inhaler adherence: Overall adherence to budesonide maintenance was 56%.
- More frequent clinic visits than expected in routine clinical practice. - Open-label design may introduce bias. - Exacerbation rate was lower than anticipated, but the relative rate difference was greater than predicted.
- AstraZeneca and the Health Research Council of New Zealand.
- "As-needed Budesonide–Formoterol versus Maintenance Budesonide in Mild Asthma." The New England Journal of Medicine, 2018. - "Inhaled Combined Budesonide–Formoterol as Needed in Mild Asthma." The New England Journal of Medicine, 2018.