Once daily fixed dose inhaler of steroids and LABA effective in asthma, finds study

Researchers across 24 countries conducted a trial from over 316 centres to assess the efficacy and safety of once-daily FDC of mometasone furoate plus indacaterol acetate (MF–IND) versus mometasone furoate (MF) monotherapy in patients with inadequately controlled asthma. The trial was conducted on patients aged 12 to 75yrs from Dec 29, 2015, to May 4, 2018. Inclusion criteria were those who had a documented diagnosis of asthma for at least 1 year, a predicted FEV1 of 50–85%, and an Asthma Control Questionnaire 7 score of at least 1·5. Patients who were under treatment with medium-dose or high-dose ICS or low-dose ICS plus LABA were also included.

Based on these the selected patients were randomly assigned (1:1:1:1:1) via interactive response technology to receive one of the following treatments for 52 weeks. They were under high-dose MF–IND (320 μg, 150 μg) or medium-dose MF–IND (160 μg, 150 μg) once daily via Breezhaler; high-dose MF (800 μg [400 μg twice daily]) or medium-dose MF (400 μg once daily) via Twisthaler; or high-dose fluticasone propionate–salmeterol xinafoate (FLU–SAL; 500 μg, 50 μg) twice daily via Diskus. Participants received placebo via inhalation through the Breezhaler, Twisthaler, or Diskus devices in the mornings and evenings, as appropriate. Improvement in trough FEV1 from baseline at 26 weeks was the primary endpoint.

The key findings of the study were:

• 2216 patients were randomly assigned. Out of these there were 445 in high-dose MF–IND; 439 in medium-dose MF–IND; 442 in high-dose MF; 444 in medium-dose MF;446 in high-dose FLU–SAL.

• Out of these 1973 (89·0%) completed the study treatment and 234 (10·6%) prematurely discontinued study treatment.

• High-dose MF–IND and medium-dose MF–IND showed superiority in improving trough FEV1 over corresponding MF doses from baseline at week 26.

• High-dose MF–IND was non-inferior to high-dose FLU–SAL in improving trough FEV1 from baseline at week 26.

• Overall, the incidence of adverse events was similar across the treatment groups.

Thus the authors concluded that once-daily FDC of ICS and LABA (MF−IND) significantly improved lung function over ICS monotherapy (MF) at week 26. They also found that high-dose MF–IND was non-inferior to twice-daily combination of ICS and LABA (high-dose FLU–SAL) for improvement in trough FEV1. The combination of MF–IND provides a novel once-daily dry powder option for asthma control.

for further reading, click the following link: https://doi.org/10.1016/S2213-2600(20)30178-8