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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720 for reporting.

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 more

Trial 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

68,450 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any spots still available for individuals to join the trial?

"According to the listings on clinicaltrials.gov, this research project is not accepting patients at present. The trial initially opened its doors for enrolment on December 10th 2022 and was last updated a few weeks ago on November 21st 2022. Despite this particular study being closed off from new participants, there are still 101 other trials that remain open for enrollment right now."

Answered by AI

Has the FDA accredited Arm 1: I-ASA 100mg, then C-ASA 162mg tablet?

"Since there is only minimal data available on the safety and efficacy of Arm 1: I-ASA 100mg, then C-ASA 162mg tablet, it was given a risk score of one."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05625347.