There are no clinically important differences in asthma symptom control between treatment with as-needed budesonide-formoterol vs maintenance budesonide plus short-acting beta2-agonist (SABA) in patients with well- or partially-controlled asthma symptoms at baseline. This was among the findings of post hoc analyses of clinical trial results published in BMJ Open Respiratory Research.
Previous randomized controlled trials have shown a greater reduction in severe exacerbation risk in adolescents and adults using as-needed inhaled corticosteroid (ICS)-formoterol reliever therapy vs those using maintenance ICS plus SABA reliever. However, the same trials also indicate that as-needed ICS-formoterol reliever therapy results in worse control of asthma symptoms, as measured by mean Asthma Control Questionnaire-5 (ACQ-5) score, than maintenance ICS plus SABA reliever. Researchers therefore sought to evaluate how the 2 asthma treatments compared with respect to levels and changes in asthma control among patients with well- or partially-controlled asthma at baseline.
The investigators conducted a post hoc analyses of 2 different 52-week clinical trials involving comparisons of budesonide vs budesonide-formoterol asthma therapies: the Novel START trial of adults with mild asthma, and the PRACTICAL trial of adults with mild to moderate asthma. The researchers calculated the number and proportion of participants at the conclusion of each trial in the ACQ-5 categories for inadequately controlled, partly controlled, and well-controlled asthma symptoms. Investigators then analyzed the participants in each of these responder categories to determine the proportion of patients who were worse, unchanged, or improved from baseline after using as-needed budesonide-formoterol vs maintenance budesonide plus SABA treatment. Researchers imputed missing data using the last- observation-carried-forward approach.
The investigators found that in the budesonide-formoterol group, 189/214 (88.3%) of patients in Novel START and 354/434 (81.6%) of patients in PRACTICAL had partly controlled or well-controlled symptoms at the conclusion of the study. In the budesonide maintenance group, 183/214 (85.5%) of patients in Novel START and 358/431 (83.1%) of patients in PRACTICAL had partly controlled or well-controlled symptoms at the study’s end.
The investigators noted that 88.8% of patients in Novel START and 84.8% of patients in PRACTICAL experienced improved or unchanged symptom control from baseline for budesonide-formoterol vs 86.4% of patients in Novel START and 87.2% of patients in PRACTICAL who experienced improved or unchanged symptom control from baseline for maintenance budesonide.
Study limitations include the use of a last observation carried forward approach, which adds to imprecision, and response bias.
Researchers concluded that “There were no clinically important differences in the proportions of patients with ‘well-controlled’ or ‘partly controlled’ asthma symptoms, or proportions who improved or maintained their level of control, with as-needed budesonide-formoterol versus maintenance budesonide plus SABA.”
Disclosure: This research was part of the Novel START trial and was supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Hatter L, Houghton C, Bruce P, et al; Novel START and PRACTICAL study teams. Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials. BMJ Open Respir Res. August 2022;9(1):e001271. doi:10.1136/bmjresp-2022-001271