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
Obstructive Pulmonary Function, Restrictive Pulmonary Function
About this trial
This is an interventional treatment trial for Obstructive Pulmonary Function focused on measuring ASA, acetylsalicylic acid, cyclooxygenase-1 enzyme, COPD, oral inhalation, inhaled, myocardial Infarction
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: All Cohorts: Presence of clinically significant uncontrolled or unstable cardiovascular, pulmonary, hepatic, renal, endocrinological, hematological, immunologic, metabolic, psychological, neurological, or gastrointestinal disease. Any new clinically significant abnormal finding at physical examination at screening. Positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or TB test at screening. Positive pregnancy test or lactating female subject. Positive urine drug screen or alcohol breath test. Positive test for active COVID-19. Known allergic reactions, hypersensitivity or contraindications to ASA, ibuprofen, other NSAID, or other related drugs, or to any excipient in the formulation. Known lack of response (lack of effect) to aspirin in the past. Clinically significant ECG abnormalities or vital signs abnormalities at screening. Clinically significant abnormal laboratory parameters at screening Presence of active or latent tuberculosis. History of asthma, including childhood asthma, syndrome of asthma, rhinitis (including allergic rhinitis), nasal polyps, angioedema, urticaria, angioedema, or bronchospasm that in investigator's opinion is not suitable to participate in the study. Subject with current asthma defined as post-bronchodilator FEV1 > 12% increase AND >200 ml absolute increase from pre-bronchodilator values. History of non-trauma related hemorrhage. Restrictive Pulmonary Function Cohort Subject had lung surgery, with lung removal, as the reason for restrictive pulmonary function. Subject receiving systemic corticosteroid treatment of prednisone > 10 mg/day or equivalent within 3 months of screening. Subject suffers from restrictive pulmonary function, co-existent with obstructive pulmonary function disease. Subject has baseline resting oxygen saturation of < 89% on room air. Subject in need of continuous oxygen use and/or prescribed long-term continuous home oxygen therapy. Other Protocol defined I/E criteria that apply
Sites / Locations
- Clinical Site Partners, LLC CSP OrlandoRecruiting
- Sinai HospitalRecruiting
- Hassman Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm 1: I-ASA 100mg, then C-ASA 162mg tablet
Arm 2: C-ASA 162mg tablet, then I-ASA 100mg
Treatment A: Single dose of 100 mg ASA powder for oral inhalation (I-ASA) via DPI. Treatment B: Single dose of 162 mg chewable non-enteric-coated Aspirin (C-ASA) tablets.
Treatment A: Single dose of 162 mg chewable non-enteric-coated Aspirin (C-ASA)tablets. Treatment B: Single dose of 100 mg ASA powder for oral inhalation (I-ASA) via DPI.