Budesonide-albuterol lowers exercise-induced bronchoconstriction in patients with asthma

Treatment with a fixed-dose combination of budesonide and albuterol (BDA) in a single pressurized metered-dose inhaler (pMDI), also known as PT027, significantly prevents exercise-induced bronchoconstriction (EIB) in adolescents and adults with asthma, according to the TYREE* study presented at ATS 2021.

“EIB is an acute narrowing of the airways that occurs as a result of exercise … and can affect up to 90 percent of patients with a diagnosis of asthma, … and [PT027 or BDA pMDI] is currently in clinical development as [a] rescue therapy,” said lead author Dr Craig LaForce from North Carolina Clinical Research in Raleigh, North Carolina, US.

This phase III, double-blind, single-dose, crossover study involved 60 adolescent and adult patients (aged 12–70 years) diagnosed with asthma and EIB. Participants were randomized in a 1:1 ratio to receive BDA pMDI 160/180 µg or placebo pMDI (n=59) as initial treatment at the first visit. They subsequently switched to the other treatment group at the second visit. The primary endpoint of the study was the maximum percentage fall in FEV₁** from baseline after 60 minutes of exercise challenge test (ECT). [ATS 2021, abstract A1200]

The mean maximum percentage fall in FEV₁ from baseline was significantly lower among patients treated with BDA pMDI compared with placebo (5.45 percent vs 18.97 percent, treatment difference, -13.51 percent; p<0.001).

When patients were stratified according to their background inhaled corticosteroid (ICS) therapy, patients in the BDA pMDI arm achieved a significantly lower mean maximum percentage fall in FEV₁ from baseline than those in the placebo arm, regardless of whether they are ICS users (6.65 percent vs 18.00 percent, treatment difference, -11.35 percent; p<0.001) or non-ICS users (4.27 percent vs 19.99, treatment difference, -15.73 percent; p<0.001).

A significantly higher proportion of patients on BDA pMDI vs those on placebo were found to be fully protected (78.3 percent vs 28.3 percent; odds ratio [OR], 10.55; p<0.001) or at least partially protected (90.0 percent vs 51.7 percent; OR, 10.85; p<0.001) against EIB, in terms of maximum percentage fall in FEV₁ of <10 or <20 percent post-ECT, respectively.

Two subjects in the placebo arm experienced adverse events, such as dyspnoea and anxiety, whereas none was reported in the BDA pMDI arm, said LaForce.

“In this first report of phase III [TYREE study, we found that] BDA pMDI significantly reduced the maximum percentage fall from baseline in FEV₁ observed over 60 minutes post-exercise vs placebo,” said LaForce.

“[This combination] also increased the odds of being fully or at least partially protected from EIB in patients with asthma, … and these findings were consistent regardless … of whether subjects were receiving … background ICS therapy,” he added.

*TYREE: A study to assess the efficacy of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) on exercise-induced bronchoconstriction in adults and adolescents with asthma