Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients

Korábbi kezelés

• Current evidence or recent history of significant comorbidities; including cardiovascular disease (such as myocardial infarction, cardiac failure, uncontrolled hypertension, or life-threatening arrhythmias), uncontrolled diabetes, neurologic, psychiatric, hepatic, renal, immunological, or hematological conditions within the last 6 months prior to Screening Visit 1
• Lower respiratory tract infection within 6 weeks prior to Screening Visit 1
• Recent history of hospitalization due to an exacerbation of airway disease or acute worsening of COPD requiring antibiotic or systemic corticosteroid treatment within 6 months prior to Screening Visit 1
• Prior lung volume reduction surgery or history of chest/lung irradiation
• Daily oxygen therapy for \> 12 hours per day
• Current or recent history of medical conditions that are contraindicated for use of an inhaled LAMA (such as urinary retention or bladder neck obstruction type symptoms, prostatic hypertrophy, or narrow-angle glaucoma) within the last 6 months prior to Screening Visit 1
• Current or recent history (previous 12 months) of excessive use or abuse of alcohol (males \>21 units per week and females \>14 units per week)
• Current evidence or history (within the past 2 years) of abusing legal drugs or use of illegal drugs or substances
• Major surgery (requiring general anaesthesia) within 6 weeks prior to Screening Visit 1, or planned surgery through the EOS Visit
• Participation in another investigational drug trial within 30 days of the last dose, 5 half-lives or twice the duration of the biological effect, whichever is longer, prior to Screening Visit 1

Más betegség

• Other respiratory disorders: Current diagnosis of predominant asthma, lung cancer, bronchiectasis, interstitial lung disease, tuberculosis, pulmonary hypertension, or other non-specific pulmonary diseases
• History of malignancy of any organ system, except for localized skin cancers, within 5 years prior to Screening Visit 1
• History of intolerance or hypersensitivity to any of the ingredients in the formulation for AERO-001, AERO-002, AERO-007, or other aerosol medications

Laborértékek

• Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) type 1 and/or 2 antibodies at Screening Visit 1

Egyéb

• Body mass index \>35 kg/m2
• Abnormal and clinically significant 12-lead ECG findings at Screening Visit 1
• Donation of 450 mL of blood within 8 weeks of Screening Visit 1
• History or high risk of noncompliance with trial visits and procedures or unsuitable for entry into the trial at the discretion of the Investigator

• 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