Chronic Obstructive Pulmonary DiseasePhase 1NCT03250182

A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose

A Phase 1 study testing PT010 in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: PT010
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 11 Aug 2017to 7 Dec 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Given their signed written informed consent to participate.
Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines.
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Pre-bronchodilator FEV1/FVC ratio must be <0.70 and pre-bronchodilator FEV1 must be ≥50% and <80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations

Who cannot join

Significant diseases or conditions to : other than COPD, active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease and uncontrolled sleep apnea .
Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
Subjects who have a history of hypersensitivity to any corticosteroid,
β2-agonist, muscarinic anticholinergic, or any component of the MDI
Alpha-1 antitrypsin deficiency as the cause of COPD

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Clearwater, Florida, 33765

Other trials in United States

About this study

Official title: A Study to Assess the Pharmacokinetics and Safety of PT010 in Subjects With Moderate to Severe COPD Following Single and Repeat Dose Administration

This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single dose administration on the first treatment day (Day 1) and will be assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to 28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at least 5 days but no longer than 7 days after the last dose of study drug.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: PT010
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

PT010Drug
Also called PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol.

Study groups in NCT03250182
Study group	Role	What they receive
PT010	Experimental	PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol per protocol. Administered as 2 inhalations per use as instructed in the protocol. Receives: Drug: PT010

What is being measured

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

Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) - Budesonide
Measured: Day 1
Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) - Budesonide
Measured: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) - Glycopyrronium
Measured: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) - Glycopyrronium
Measured: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) - Formoterol
Measured: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) - Formoterol
Measured: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
Measured: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
Measured: Day 8
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
Measured: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
Measured: Day 8
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
Measured: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
Measured: Day 8
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Budesonide
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Budesonide
Measured: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Glycopyrronium
Measured: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Formoterol
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Formoterol
Measured: Day 1

Secondary outcomes (6)

Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time to maximum plasma concentration (tmax) - Budesonide
Measured: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time to maximum plasma concentration (tmax) - Glycopyrronium
Measured: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time to maximum plasma concentration (tmax) - Formoterol
Measured: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Budesonide
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Budesonide
Measured: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Glycopyrronium
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Glycopyrronium
Measured: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Formoterol
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Formoterol
Measured: Day 1

Timeline

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

11 Aug 20177 Dec 2017

First posted15 Aug 2017
Study start11 Aug 2017
Primary completion7 Dec 2017
Study completion7 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03250182
Sponsor's protocol ID: PT010018
Status last verified: Jan 2021
First submitted: 11 Aug 2017
Last updated: 29 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Dunn LJ, Kerwin EM, DeAngelis K, Darken P, Gillen M, Dorinsky P. Pharmacokinetics of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler formulated using co-suspension delivery technology after single and chronic dosing in patients with COPD. Pulm Pharmacol Ther. 2020 Feb;60:101873. doi: 10.1016/j.pupt.2019.101873. Epub 2019 Dec 10.
PubMed 31841699

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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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess the Pharmacokinetics and Safety of PT010 in Subjects With Moderate to Severe COPD Following Single and Repeat Dose Administration
ClinicalTrials.gov ID: NCT03250182
Acronym / sponsor ID: PT010018
Conditions: Chronic Obstructive Pulmonary Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 11 Aug 2017 (actual)
Primary completion: 7 Dec 2017 (actual)
Study completion: 7 Dec 2017 (actual)
First posted: 15 Aug 2017 (actual)
Results: Posted 8 May 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PT010	Experimental	Drug: PT010PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol per protocol. Administered as 2 inhalations per use as instructed in the protocol.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Given their signed written informed consent to participate.
Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines.
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Pre-bronchodilator FEV1/FVC ratio must be <0.70 and pre-bronchodilator FEV1 must be ≥50% and <80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations

Key exclusion criteria (6 listed)

Significant diseases or conditions to : other than COPD, active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease and uncontrolled sleep apnea .
Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
Subjects who have a history of hypersensitivity to any corticosteroid,
β2-agonist, muscarinic anticholinergic, or any component of the MDI

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
PT010Also: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation AerosolPT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol.	Drug	PT010

Primary outcome

Maximum Plasma Concentration (Cmax) - Budesonide
Time frame: Day 1
Maximum plasma concentration (Cmax) - Budesonide
Maximum Plasma Concentration (Cmax) - Budesonide
Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose
Maximum plasma concentration (Cmax) - Budesonide
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Maximum plasma concentration (Cmax) - Glycopyrronium
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Maximum plasma concentration (Cmax) - Glycopyrronium
Maximum Plasma Concentration (Cmax) - Formoterol
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Maximum plasma concentration (Cmax) - Formoterol
Maximum Plasma Concentration (Cmax) - Formoterol
Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Maximum plasma concentration (Cmax) - Formoterol
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide
Time frame: Day 1
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide
Time frame: Day 8
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium
Time frame: Day 1
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium
Time frame: Day 8
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol
Time frame: Day 1
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol
Time frame: Day 8
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Budesonide
Time frame: Day 1
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Budesonide
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Glycopyrronium
Time frame: Day 1
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Glycopyrronium
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Formoterol
Time frame: Day 1
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Formoterol

6 secondary outcomes

Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Budesonide
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Glycopyrronium
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Formoterol
Time frame: Day 1

Results and safety

Results posted to the registry on 8 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PT010	30	29

Primary outcome: Maximum Plasma Concentration (Cmax) - Budesonide

Time frame: Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	PT010 n = 29
Value	709.3 (57.2)

Population analysed: PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis.

Primary outcome: Maximum Plasma Concentration (Cmax) - Budesonide

Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	PT010 n = 27
Value	663.2 (65.8)

Primary outcome: Maximum Plasma Concentration (Cmax) - Glycopyrronium

Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose). Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	PT010 n = 27
Value	17.2 (80.7)

Primary outcome: Maximum Plasma Concentration (Cmax) - Glycopyrronium

Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose). Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	PT010 n = 25
Value	18.3 (65.4)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of administration of the first dose of study drug to the time of the final follow-up telephone call up to approximately 7 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PT010	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31841699Dunn LJ, Kerwin EM, DeAngelis K, Darken P, Gillen M, Dorinsky P. Pharmacokinetics of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler formulated using co-suspension delivery technology after single and chronic dosing in patients with COPD. Pulm Pharmacol Ther. 2020 Feb;60:101873. doi: 10.1016/j.pupt.2019.101873. Epub 2019 Dec 10.

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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.

Paul M Dorinsky, MD study director

Pearl Therapeutics, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PT010 in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 1 site in United States.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 8 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Plasma Concentration (Cmax) - Budesonide (time frame: Day 1). The study lists 15 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 NCT03250182, which also lists 1 linked publication.

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 29 Jan 2021.