Study to Compare the Pharmacokinetics and Pharmacodynamics of ASA Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Adult Subjects With Obstructive or Restrictive Pulmonary Function

All Cohorts

Subjects must meet all of the following criteria to be included in the study:

Male or female, ≥ 40 years of age.

BMI \>18.0 and \<35.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.

Clinically stable as determined by medical history, physical examination, vital signs, and clinical laboratory evaluation.

Female subjects of non-childbearing potential must be: post-menopausal; or surgically sterile at least 3 months prior to first dosing.

Sexually active female subjects of childbearing potential must be willing to use an acceptable contraceptive method throughout the study as detailed in protocol.

Smoker (no more than 25 cigarettes or equivalent daily) or non-smoker.

Obstructive Pulmonary Function Cohort

Subject with a smoking history of at least 10 pack-years.

Subject with an established diagnosis of COPD at least 12 months prior to the screening visit AND confirmed at screening by spirometry, with a post bronchodilator FEV1 greater than 40% and equal to or less than 70% of the subject's normal predicted value and a post-bronchodilator FEV1 greater than 40% and equal to or less than 70% of the subject's normal predicted value and a post-bronchodilator FEV1/ FVC ratio \< 0.70.

Subject on stable uninterrupted maintenance COPD therapy for at least 3 months prior to screening as per SoC and without any history of moderate or severe exacerbations within 6 months prior to screening.

Non-symptomatic subject on stable uninterrupted maintenance COPD therapy, such that, in the judgement of the Investigator, on the day of dosing in each period, it would be safe to withhold the morning dose of the maintenance treatment until 2 hours post-dose and to withhold PRN short acting rescue bronchodilators from 1 hour pre-dose until 2 hours post-dose.

Restrictive Pulmonary Function Cohort

Subject with a history and documented prior diagnosis of underlying chronic respiratory or cardiac disease with restrictive pulmonary function as confirmed at the screening visit by:

FEV1/FVC ≥ 0. 7 and

FVC \< LLN (or \< 80% predicted) and

TLC \< 5th percentile predicted (or \< 80% predicted) and

DLCO ≤ 75% to ≥ 35% predicted

Continued uninterrupted SoC therapy for underlying disease for at least 12 consecutive weeks immediately prior to screening.

Stable patient, such that, in the judgement of the Investigator, on the day of dosing in each period, it would be safe to withhold the morning dose of the maintenance treatment until 2 hours post-dose and to withhold short acting rescue bronchodilators, if any, from 1 hour pre-dose until 2 hours post-dose.

What this study is about