A few days ago, AstraZeneca announced the positive results of two phase III trials of its fixed-dose combination of salbutamol and budesonide in patients with moderate to severe asthma.

PT027, jointly developed by AstraZeneca and Avillion, is a potential first-in-class inhaled fixed-dose combination. The drug is mainly composed of short-acting β2-agonist (SABA) salbutamol and inhaled corticosteroid (ICS) budesonide. The indication for this combination therapy, asthma, is a chronic, inflammatory, and fluctuating respiratory disease that affects as many as 339 million adults and children worldwide. The company said that compared with 180mcg of salbutamol and 160mcg of budesonide, the two doses of PT027 (180/160mcg and 180/80mcg) reached all the primary endpoints in the two phase three trials. PT027 showed a positive effect. There are treatment benefits for asthma patients.

According to the results of the MANDALA Phase III trial announced this time, compared with salbutamol, when PT027 is used as a rescue drug for asthma symptoms, the combination therapy can statistically and clinically significantly reduce the risk of severe deterioration in patients. The trial enrolled 3,132 patients with moderate to severe asthma, all of whom were treated with maintenance ICS, with or without additional control medications.

Another DENALI Phase III trial also produced similar positive results. The trial involved 1,001 patients with mild to moderate asthma who had previously used SABA alone or combined with low-dose maintenance ICS as needed. The test results showed that compared with the treatment of salbutamol and budesonide alone, by measuring the forced expiratory volume in one second (FEV1), the lung function of patients treated with PT027 showed a statistically significant improvement.

In this regard, Mene Pangalos, Executive Vice President of Research and Development of AstraZeneca Biopharmaceuticals, said, “All asthma patients are at risk of severe deterioration, regardless of the severity of their disease, and it is well known that many patients overuse short-acting bronchodilators. The exciting test results announced by PT027 this time may provide an innovative and excellent asthma treatment method by preventing the worsening of asthma." The company pointed out that the safety and tolerability of PT027 in the two trials The sex is consistent with the known compositional characteristics. AstraZeneca said in a statement that detailed data from the MANDALA and DENALI trials will be announced at an upcoming medical conference.