AstraZeneca has unveiled data from two Phase III trials showing the benefit of using Symbicort Turbuhaler as an anti-inflammatory reliever ‘as needed’ versus two different treatment regimens in patients with mild asthma.
The trials tested the inhaler in place of current reliever therapy, a short-acting beta2-agonist (SABA), also taken as needed, and as an alternative to regular maintenance controller therapy (twice-daily budesonide, an inhaled corticosteroid, ICS) plus SABA ‘as needed’.
According to the data, which was published in the New England Journal of Medicine, Symbicort Turbuhaler ‘as needed’ demonstrated superior asthma-symptom control (34.4 percent versus 31.1 percent) and a 64 percent reduction in exacerbations versus SABA ‘as needed’.
Also, AZ’ inhaler was found to be non-inferior to twice-daily budesonide maintenance therapy plus SABA ‘as needed’ in reducing the risk of severe asthma exacerbations (0.11 versus 0.12), which was achieved with 25 percent of the budesonide maintenance dose.
On the downside, Symbicort Turbuhaler taken only as needed did not achieve non-inferiority in electronically recorded well-controlled asthma weeks versus twice-daily budesonide plus SABA.
According to Dr Colin Reisner, head of Respiratory, Global Medicines Development at AZ, the data “show the potential value of Symbicort as an anti-inflammatory reliever ‘as needed’ in mild asthma, building on the established benefits of Symbicort in moderate to severe disease.”
“We know that many 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 preventable exacerbations. The SYGMA trials provide important new data which could improve the treatment of mild asthma and inform management guidelines,” added Paul O’Byrne, dean and vice-president, Faculty of Health Sciences at McMaster University, Canada, and the International Coordinating Investigator for SYGMA 1.
Symbicort is a combination formulation containing budesonide, an ICS that treats underlying inflammation, and formoterol, a long-acting beta2-agonist bronchodilator (LABA) with a fast onset of action, in a single inhaler.
The therapy was launched in 2000, and is approved in around 120 countries to treat asthma and/or COPD either as Symbicort Turbuhaler or Symbicort pMDI (pressurised metered-dose inhaler).