A long-acting beta antagonist (LABA) combined with a long-acting muscarinic antagonist (LAMA) is considered superior to monotherapy or corticosteroid/LABA therapy in terms of improving lung function and alleviating symptoms in COPD patients.
But not all patients respond well to dry powder inhalers (DPIs) or pressurized metered-dose inhalers (PMDIs). HL231, a nebulized inhalant, could provide an alternative treatment for those patients.
That’s according to the new study, “Efficacy, Pharmacokinetics and Safety of Nebulized HL231 Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Trial,” which was published in the Journal of Thoracic Disease.
According to a news release, the study used a multicenter, randomized, single-dose, single-blind, crossover design and was initiated between December 2021 and May 2023.
The study was divided into two parts. In Part A, patients were randomized to receive a single dose of HL231, Ultibro (a LABA/LAMA fixed dose DPI) or placebo in a randomized sequence with a washout period of at least 14 days between two visits. In Part B, patients were randomized to receive a single dose of HL231 or Ultibro (no placebo) in randomized sequence.
The study found that HL231 achieved comparable bronchodilation efficacy, pharmacokinetic profiles and safety outcomes compared to Ultibro. It also showed a clear dose-response relationship at higher doses with predominantly mild to moderate adverse events.
The researchers wrote that the study provides the first evidence that HL231 offers equivalent efficacy to a nebulized alternative. The findings suggest that HL231 could serve as an alternative for patients who are unable to use DPIs or PMDIs.
This expands treatment options and may improve adherence among those patients, the researchers said, adding that the findings should prompt clinicians to consider HL231 for device-challenged patients. They also noted treatment guides should be updated to include nebulized options and further research into long-term outcomes and cost-effectiveness is needed.
