AeroRx Therapeutics has reported Phase IIa data for AERO-007, a nebulized fixed-dose combination of indacaterol and glycopyrrolate, showing statistically significant improvements in lung function over 24 hours in patients with moderate-to-severe COPD — positioning the inhaled LABA LAMA combination as a potential once-daily nebulized alternative to existing dry-powder inhaler regimens.
Trial specifics
The Phase IIa COPD data come from a randomized, double-blind, placebo-controlled, single-dose, three-period crossover study enrolling 16 patients with moderate-to-severe COPD. Participants received AERO-007 at two dose levels — 100/50 µg and 200/100 µg (indacaterol/glycopyrrolate) — and placebo, each separated by a washout period, administered via an LC Sprint standard jet nebulizer. Pulmonary function was assessed by serial spirometry over 24 hours post-dose. The study evaluated safety, tolerability, pharmacokinetics, and efficacy. Data were presented by AeroRx chief executive Ahmet Tutuncu at the American Thoracic Society 2026 International Conference on May 17.
Both dose levels produced statistically significant and sustained bronchodilation relative to placebo. Placebo-adjusted standardized FEV₁ AUC₀₋₂₄ₕ was 251 mL for the 100/50 µg dose and 262 mL for the 200/100 µg dose, both at p<0.001. Placebo-adjusted peak change from baseline in FEV₁ reached 311 mL and 302 mL, respectively. A 200 mL improvement in FEV₁ is widely cited as a threshold for clinical meaningfulness in COPD, and both dose levels exceeded that bar on peak response. Systemic pharmacokinetic exposures to indacaterol and glycopyrrolate were reported as similar to or below those observed with Novartis's Utibron Neohaler (indacaterol/glycopyrrolate) dry-powder inhaler at its approved twice-daily dose of 27.5/15.6 µg, which the company said supports a favorable systemic safety profile for the nebulized formulation. AERO-007 was well tolerated at both dose levels; most treatment-emergent adverse events were mild, and none led to treatment discontinuation.
The crossover design in 16 patients limits the interpretive weight of these findings. This is a single-dose, dose-ranging study, and the absence of a head-to-head active comparator arm means the efficacy signal cannot be directly benchmarked against approved therapies. Still, the consistency across dose levels and the sustained 24-hour bronchodilation provide a functional rationale for advancing to larger, longer-duration trials.
The case for nebulized COPD treatment
The clinical rationale for a nebulized COPD maintenance therapy rests on documented limitations of handheld inhaler use in real-world practice. Published data cited by AeroRx suggest that up to 75% of patients do not receive the full therapeutic dose from dry-powder or pressurized metered-dose inhalers, largely due to coordination demands and the need for forceful inhalation — challenges that are more pronounced in older adults and those with advanced disease. Nebulized delivery requires only passive breathing, which may translate to more consistent lung deposition in these populations.
Despite this, no fixed-dose nebulized LABA LAMA combination has previously reached clinical development. The approved LABA LAMA landscape for COPD is dominated by dry-powder and metered-dose inhaler formats. Novartis's Utibron Neohaler received FDA approval in 2015 as a twice-daily dry-powder inhaler. AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol), a triple-therapy pressurized metered-dose inhaler, was approved by the FDA in 2020, representing the most recent major regulatory milestone in the inhaled combination COPD space. Nebulized monotherapy options exist, but a dual bronchodilator in a single nebulized formulation has remained absent from the market.