Patients with mild asthma who received budesonide/formoterol (BUD/FORM) or BUD 200µg twice daily with as-needed terbutaline had reduced rates of exacerbation regardless of prior treatment, according to recent research from a secondary analysis from the SYGMA trials presented at the American Thoracic Society meeting in Dallas.

The Symbicort Given as Needed in Mild Asthma (SYGMA) 1 trial randomized patients to receive twice-daily combination placebo and terbutaline at 0.5mg as needed, twice-daily combination placebo plus BUD/FORM treatment at 200/6µg as needed, or combination BUD at 200µg plus terbutaline as needed. Patients had uncontrolled asthma and were eligible for Global Initiative for Asthma (GINA) step 2 treatment. In SYGMA 2, patients received either as-needed BUD/FORM 200/6µg or twice-daily terbutaline at 200µg (BUD maintenance). Outcomes assessed in both trials were asthma symptom control (ACQ-5) between-treatment changes, rate of exacerbations and pre-bronchodilator FEV1.

Doctor giving presentation. Source: Getty

In the secondary analysis, patients who received inhaled corticosteroids (ICS) were placed in subgroup 1, while those who received leukotriene receptor antagonists (LTRA) were in subgroup 2. While there were between-group similarities in baseline demographics, subgroup 1 had lower pre-bronchodilator FEV₁ and longer time since diagnosis than subgroup 2.

“Patients with mild asthma requiring GINA step 2 treatment, and regardless of previous treatment, as-needed BUD/FORM and BUD maintenance were associated with similar exacerbation rates that were significantly lower versus as-needed terbutaline,” Eric Bateman, MB ChB, MD, FRCP, DCH, from the Division of Pulmonology and Department of Medicine at the University of Cape Town in Cape Town, South Africa, and colleagues wrote in their abstract. “Improvements from baseline in lung function and symptom control were greater with ICS-containing regimens than with as-needed terbutaline, and similar between pre-study treatment subgroups.”

Patients receiving BUD/FORM as needed in subgroup 1 and subgroup 2 had a lower exacerbation rate compared with terbutaline, and this effect was similar when comparing patients in the SYGMA 1 and SYGMA 2 trials who received BUD maintenance compared with terbutaline as needed. Among patients who received ICS, there were greater lung function improvements compared with those patients who received terbutaline as needed, with similar effects seen in symptom control for these groups, and this effect was larger in subgroup 1 compared with subgroup 2, researchers said.

Pre-study treatment groups and randomization treatment groups did not significantly differ with regard to exacerbation rates, and there were no clinically relevant differences between patients in the BUD/FORM group and BUD maintenance group in either subgroup 1 or subgroup 2. In the SYGMA 2 study, there was a significant difference in change in ACQ-5 but no clinically important differences between randomization groups.