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Nonsteroidal Anti-inflammatory Drug
Arm 1: I-ASA 100mg, then C-ASA 162mg tablet for Obstructive Pulmonary Disease
Phase 1
Waitlist Available
Research Sponsored by Vectura, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Awards & highlights
Study Summary
This trial compares safety, effectiveness, and side effects of two forms of aspirin given to adults with lung issues.
Eligible Conditions
- Obstructive Pulmonary Disease
- Restrictive Lung Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the ASA plasma concentration versus time curve (AUC0-inf)
Area under the ASA plasma concentration versus time curve (AUC0-t)
Peak plasma concentration of ASA (Cmax)
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC0-inf) of SA.
Area under the plasma concentration versus time curve (AUC0-t) of SA.
Incidence and frequency of adverse events
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: C-ASA 162mg tablet, then I-ASA 100mgExperimental Treatment2 Interventions
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.
Group II: Arm 1: I-ASA 100mg, then C-ASA 162mg tabletExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Vectura, Inc.Lead Sponsor
1 Previous Clinical Trials
86 Total Patients Enrolled
Syneos HealthOTHER
172 Previous Clinical Trials
68,199 Total Patients Enrolled
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