Randomized, Double-Blind, Placebo-Controlled, 14-Day Treatment, 2-Period Crossover Trial Evaluating the Lung Function Response After Treatment With Inhaled LABA and LAMA Monotherapies and Their Combination AERO-007 Administered Via Nebulization in Participants With Chronic Obstructive Pulmonary Disease (COPD) (AERODUO-2 Trial)
This is a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging,14-day dosing, 2-period crossover study in participants with chronic obstructive pulmonary disease (COPD).
• Male or female aged 40 to 75 years, inclusive, at the time of informed consent
• Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Report, 2026 for at least 12 months prior to Screening Visit 1
• Post-bronchodilator spirometry (after 10 to 30 minutes following 4 puffs of albuterol via MDI with a spacer) at Screening Visit 2 demonstrating the following:
‣ FEV1 \> 40 and \< 80% of predicted normal (using the Global Lung Function Initiative \[GLI\] 2012 reference values)
⁃ FEV1/forced vital capacity (FVC) ratio \< 0.70
⁃ ≥ 150 mL increase from pre-bronchodilator FEV1 following 4 puffs of albuterol
• Ability to change current COPD therapy and discontinue long-acting bronchodilators, if applicable, for the duration of the trial and short-acting bronchodilators for 8 hours prior to dosing at each Treatment Visit
• Current or former-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, 10 packs/day for 1 year)
• Ability to perform reproducible spirometry according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines
• Female participants of childbearing potential must not be pregnant, breast feeding or lactating and heterosexual female participants of childbearing potential must agree to use, with their partner, a male condom plus an approved method of highly effective birth control from the time of informed consent and for 30 days following the last administered dose
• Female participants of childbearing potential must have a negative serum or urine pregnancy test at Screening Visit 1 and a negative urine pregnancy test prior to dosing at each Treatment Visit
• Male participants who are sexually active with a female partner of childbearing potential must use, with their partner, a male condom plus an approved method of highly effective contraception from the time of informed consent and for 30 days following the last administered dose
• Participants must agree not to donate semen or ova/oocytes from the time of informed consent and for 30 days following the last administered dose
• Willing and able to provide written informed consent