Obstructive Pulmonary FunctionPhase 1NCT05625347

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

A Phase 1 study testing single dose (100 mg) of ASA and single dose (162 mg) of non-enteric-coated chewable aspirin tablets in people with Obstructive Pulmonary Function and Restrictive Pulmonary Function, run by Vectura, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The goal of this clinical trial is to compare the pharmacokinetics (PK) pharmacodynamics (PD), safety and tolerability of acetylsalicylic acid powder for oral inhalation (I-ASA) with non-enteric-coated chewable aspirin (C-ASA) in adult subjects with obstructive or restrictive pulmonary function. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Obstructive Pulmonary Function, Restrictive Pulmonary Function
What is being tested?: single dose (100 mg) of ASA and single dose (162 mg) of non-enteric-coated chewable aspirin tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 4 sitesUnited States
Study dates: 11 Mar 2023to 30 Jun 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Sinai Hospital
Baltimore, Maryland, 21209
Hassman Research Institute
Berlin, New Jersey, 08009
Omega Research Orlando, LLC
Orlando, Florida, 32808
Clinical Site Partners, LLC CSP Orlando
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Single-dose, Open-label, Multi-center, Randomized, 2-treatment Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Adult Subjects With Obstructive or Restrictive Pulmonary Function

In the first treatment period, subjects will be randomized to receive either a single dose (100 mg) of I-ASA powder via a Dry Powder Inhaler (DPI) OR a single dose (162 mg) of C-ASA tablets. After a washout period, subjects will be crossed over to receive the other treatment in the second treatment period. All subjects will receive both treatments during the study. Each single dose treatment will be followed by up to 24 hours of serial post-dose PK, PD, and safety/tolerability assessments.

Read the detailed description

Up to 16 adult males and females subjects are planned for enrollment in this study, to achieve a minimum of 10 subjects with evaluable PD/PK, safety, and tolerability data:

5 subjects with obstructive lung function [i.e., diagnosed with chronic obstructive pulmonary disease (COPD)]; and
5 subjects with restrictive lung function

Conditions: Obstructive Pulmonary Function, Restrictive Pulmonary Function
Being tested: single dose (100 mg) of ASA, single dose (162 mg) of non-enteric-coated chewable aspirin tablets
Keywords: ASA, acetylsalicylic acid, cyclooxygenase-1 enzyme, COPD, oral inhalation, inhaled, myocardial Infarction
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

single dose (100 mg) of ASADrug
powder for oral inhalation via a Dry Powder Inhaler (DPI)
single dose (162 mg) of non-enteric-coated chewable aspirin tabletsDrug
orally administered

Study groups in NCT05625347
Study group	Role	What they receive
Arm 1: I-ASA 100mg, then C-ASA 162mg tablet	Experimental	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. Receives: Drug: single dose (100 mg) of ASA; Drug: single dose (162 mg) of non-enteric-coated chewable aspirin tablets
Arm 2: C-ASA 162mg tablet, then I-ASA 100mg	Experimental	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. Receives: Drug: single dose (100 mg) of ASA; Drug: single dose (162 mg) of non-enteric-coated chewable aspirin tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak plasma concentration of ASA (Cmax)
Measured: pre-dose and 24 hours post-dose
Area under the ASA plasma concentration versus time curve (AUC0-inf)
Measured: pre-dose and 24 hours post-dose
Area under the ASA plasma concentration versus time curve (AUC0-t)
Measured: pre-dose and 24 hours post-dose

Secondary outcomes (17)

Tmax of plasma concentrations of ASA.
Measured: assessed up to 24 hours post-dose
Tmax of plasma concentrations of SA.
Measured: assessed up to 24 hours post-dose
Peak Plasma Concentration (Cmax) of SA.
Measured: minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Area under the plasma concentration versus time curve (AUC0-inf) of SA.
Measured: minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Area under the plasma concentration versus time curve (AUC0-t) of SA.
Measured: minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Serum thromboxane B2 (TxB2) serum concentration - Area under the effect curve (AUEC) of the % Change from baseline (CFB) in serum TxB2 concentration (TxB2 suppression).
Measured: 24 hours post-dose
TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression).
Measured: 20 minutes post-dose
TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression)
Measured: 30 minutes post-dose
Proportion of subjects achieving significant inhibition of platelet aggregation (<550 Aspirin Reaction Units [ARU])
Measured: 2 minutes
Time to significant reduction in platelet aggregation (<550 ARU)
Measured: assessed up to 24 hours post-dose
Time to half-maximal % inhibition (suppression) of serum TxB2 (ID-50).
Measured: assessed up to 24 hours post-dose
Time to maximum % inhibition of serum TxB2.
Measured: assessed up to 24 hours post-dose
Time to maximum inhibition of platelet aggregation, assessed by VerifyNow Aspirin test.
Measured: assessed up to 24 hours post-dose
Maximum % CFB in ARU assessed by VerifyNow tests.
Measured: assessed up to 24 hours post-dose
Maximum % CFB in urinary 11-dehydro-TxB2.
Measured: assessed up to 24 hours post-dose
Maximum % CFB in serum 6-keto-PGF1α levels.
Measured: assessed up to 24 hours post-dose
Incidence and frequency of adverse events
Measured: Screening through the 7-day follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 202330 Jun 2023

First posted22 Nov 2022
Study start11 Mar 2023
Primary completion30 Jun 2023
Study completion30 Jun 2023

Why it stopped: The pivotal study failed to meet the primary endpoint. Without a successful readout of the pivotal study, there was no longer a purpose for the supportive BORA-1A-C302 study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obstructive Pulmonary FunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05625347
Sponsor's protocol ID: BORA-1A-C302
Status last verified: Mar 2024
First submitted: 1 Nov 2022
Last updated: 22 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose, Open-label, Multi-center, Randomized, 2-treatment Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Adult Subjects With Obstructive or Restrictive Pulmonary Function
ClinicalTrials.gov ID: NCT05625347
Acronym / sponsor ID: BORA-1A-C302
Conditions: Obstructive Pulmonary Function, Restrictive Pulmonary Function
Keywords: ASA, acetylsalicylic acid, cyclooxygenase-1 enzyme, COPD, oral inhalation, inhaled, myocardial Infarction
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The pivotal study failed to meet the primary endpoint. Without a successful readout of the pivotal study, there was no longer a purpose for the supportive BORA-1A-C302 study.
Enrolment: 4 participants (actual)
Lead sponsor: Vectura, Inc.Industry (pharma, biotech, devices)
Collaborators: Syneos Health
Study start: 11 Mar 2023 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 22 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Up to 16 adult males and females subjects are planned for enrollment in this study, to achieve a minimum of 10 subjects with evaluable PD/PK, safety, and tolerability data:

5 subjects with obstructive lung function [i.e., diagnosed with chronic obstructive pulmonary disease (COPD)]; and
5 subjects with restrictive lung function

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1: I-ASA 100mg, then C-ASA 162mg tablet	Experimental	Drug: single dose (100 mg) of ASA, Drug: single dose (162 mg) of non-enteric-coated chewable aspirin tabletsTreatment 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.
Arm 2: C-ASA 162mg tablet, then I-ASA 100mg	Experimental	Drug: single dose (100 mg) of ASA, Drug: single dose (162 mg) of non-enteric-coated chewable aspirin tabletsTreatment 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

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.

Key exclusion criteria (22 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
single dose (100 mg) of ASApowder for oral inhalation via a Dry Powder Inhaler (DPI)	Drug	Arm 1: I-ASA 100mg, then C-ASA 162mg tablet, Arm 2: C-ASA 162mg tablet, then I-ASA 100mg
single dose (162 mg) of non-enteric-coated chewable aspirin tabletsorally administered	Drug	Arm 1: I-ASA 100mg, then C-ASA 162mg tablet, Arm 2: C-ASA 162mg tablet, then I-ASA 100mg

Primary outcome

Peak plasma concentration of ASA (Cmax)
Time frame: pre-dose and 24 hours post-dose
Area under the ASA plasma concentration versus time curve (AUC0-inf)
Time frame: pre-dose and 24 hours post-dose
Area under the ASA plasma concentration versus time curve (AUC0-t)
Time frame: pre-dose and 24 hours post-dose

17 secondary outcomes

Tmax of plasma concentrations of ASA.
Time frame: assessed up to 24 hours post-dose
Tmax of plasma concentrations of SA.
Time frame: assessed up to 24 hours post-dose
Peak Plasma Concentration (Cmax) of SA.
Time frame: minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Area under the plasma concentration versus time curve (AUC0-inf) of SA.
Time frame: minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Area under the plasma concentration versus time curve (AUC0-t) of SA.
Time frame: minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Serum thromboxane B2 (TxB2) serum concentration - Area under the effect curve (AUEC) of the % Change from baseline (CFB) in serum TxB2 concentration (TxB2 suppression).
Time frame: 24 hours post-dose
TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression).
Time frame: 20 minutes post-dose
TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression)
Time frame: 30 minutes post-dose
Proportion of subjects achieving significant inhibition of platelet aggregation (<550 Aspirin Reaction Units [ARU])
Time frame: 2 minutes
Time to significant reduction in platelet aggregation (<550 ARU)
Time frame: assessed up to 24 hours post-dose
Time to half-maximal % inhibition (suppression) of serum TxB2 (ID-50).
Time frame: assessed up to 24 hours post-dose
Time to maximum % inhibition of serum TxB2.
Time frame: assessed up to 24 hours post-dose
Time to maximum inhibition of platelet aggregation, assessed by VerifyNow Aspirin test.
Time frame: assessed up to 24 hours post-dose
Maximum % CFB in ARU assessed by VerifyNow tests.
Time frame: assessed up to 24 hours post-dose
Maximum % CFB in urinary 11-dehydro-TxB2.
Time frame: assessed up to 24 hours post-dose
Maximum % CFB in serum 6-keto-PGF1α levels.
Time frame: assessed up to 24 hours post-dose
Incidence and frequency of adverse events
Time frame: Screening through the 7-day follow-up period

Results and safety

The study was stopped early (reason given: The pivotal study failed to meet the primary endpoint. Without a successful readout of the pivotal study, there was no longer a purpose for the supportive BORA-1A-C302 study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak plasma concentration of ASA (Cmax) (time frame: pre-dose and 24 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05625347.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.