Budesonide/Formoterol Considered for As-Needed Asthma Therapy in Phase 3 Studies

MAY 22, 2018
Kevin Kunzmann
Paul M. O'Byrne, MBPaul M. O'Byrne, MB
A pair of phase 3 trials for budesonide/formoterol (Symbicort Turbuhaler) for the treatment of as-needed anti-inflammatory relief in patients with mild asthma have met primary endpoint results.

The SYGMA trials, a couple of 52-week trials that evaluated the inhaler therapy in 8000-plus patients, reported superior results in efficacy versus 2 standard-of-care therapies. Its results were presented this week at the 2018 American Thoracic Society (ATS) International Conference in San Diego, CA.

SYGMA 1 evaluated 3849 patients randomized to receive either 200/6 mcg Symbicort, 0.5 terbutaline, or tebutaline/budesonide (0.5 mg/200 mcg) plus budesonide (200 mcg).  Researchers sought a primary objective of as-needed Symbicort showing superiority to terbutaline, a short-acting beta2 agonist (SABA) as measured by well-controlled asthma weeks. Patient asthma control was recorded via electronic health records.

SYGMA 2 randomized 4215 patients to evaluate the efficacy and safety of as-needed 200/6 mcg Symbicort versus twice-daily 200 mcg budesonide plus 0.5 mg terbutaline. Researchers sought a primary objective of Symbicort non-inferiority to SABA in annual severe asthma exacerbations in patients.

In the first trial, Symbicort reported inferiority to twice-daily budesonide plus SABA, as measured by well-controlled asthma weeks in patients (34.4% versus 44.4%). Severe exacerbations in the Symbicort patients differed slightly, though not significantly, from the comparative patient group (0.07 versus 0.09). Researchers noted this rate was achieve at a substantially lower steroid dose (17% budesonide maintenance dosing).

Symbicort reported non-inferiority in reducing severe asthma exacerbations to budesonide plus SABA in the SYGMA 2 results (0.11 versus 0.12) — again at a significantly lower steroid dose (25%). However, the therapy provided less symptom control, as measured by the Asthma Control Questionnaire-5 (ACQ5).

Safety and tolerability for Symbicort were consistent with its known profile. The most frequently reported adverse events included upper respiratory tract infection (URTI), viral URTI, asthma, pharyngitis, bronchitis, headache, and allergic rhinitis.

The combination-formulation administered in a single inhaler dose, previously approved by the US Food and Drug Administration (FDA) for the treatment of moderate-to-severe asthma, has reached 120 countries’ markets since launching in 2000.

Researchers at AstraZeneca, Symbicort’s developer, noted the data shows the therapy’s potential as an anti-inflammatory reliever in mild asthma — building on its established benefits in moderate-to-severe forms of the condition.

Paul M. O’Byrne, MB, International Coordinating Investigator for SYGMA 1, observed the overall value of such a trial series for asthma.

“We know that millions of patients around the world are over-reliant on their reliever medications, which improve symptoms but do not treat inflammation, and underuse anti-inflammatory maintenance controller treatments resulting in preventing exacerbations,” O’Byrne said.

He concluded the SYGMA trials provide new and important data which could eventually improve mild asthma treatment standards and “inform management guidelines.”

The studies, “Inhaled Combined Budesonide–Formoterol as Needed in Mild Asthma,” were published online in the New England Journal of Medicine last week.

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