COPDPhase 3NCT02536508

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

A Phase 3 study testing BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg and BFF MDI 320/9.6 μg in people with COPD, run by Pearl Therapeutics, Inc. at 64 sites 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

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: COPD
What is being tested?: BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg and BFF MDI 320/9.6 μg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 627 participants
Where: 64 sitesUnited States
Study dates: 10 Aug 2015to 12 Sep 2017
Phase: Phase 3
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. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)

Who cannot join

Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery

Trial locations and contacts

64 sites in 1 country.

City, postcode or hospital

64 sites in 1 country

United States64 sites

Research Site
Abingdon, Virginia, 24210
Research Site
Albuquerque, New Mexico, 87108
Research Site
Anderson, South Carolina, 29621
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Charleston, South Carolina, 29406
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Charlotte, North Carolina, 28207
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Cincinnati, Ohio, 45231
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Cincinnati, Ohio, 45242
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Cincinnati, Ohio, 45245
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Clearwater, Florida, 33756
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Columbus, Ohio, 43213
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Columbus, Ohio, 43235
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Dacula, Georgia, 30019
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Dayton, Ohio, 45459
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Dothan, Alabama, 36303
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Dublin, Ohio, 43016
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Easley, South Carolina, 29640
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Edina, Minnesota, 55435
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Fullerton, California, 92835
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Gastonia, North Carolina, 28054
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Gold River, California, 95670
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Greensboro, North Carolina, 27408
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Greenville, South Carolina, 29615
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Hendersonville, North Carolina, 28739
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Jasper, Alabama, 35501
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Johnson City, Tennessee, 37601
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Kingwood, Texas, 77339
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Las Vegas, Nevada, 89106
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Longview, Texas, 75604
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Medford, Oregon, 97504
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Miami, Florida, 33186
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Minneapolis, Minnesota, 55402
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Minneapolis, Minnesota, 55407
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Mooresville, North Carolina, 28117
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Morgantown, West Virginia, 26505
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Mt. Pleasant, South Carolina, 29464
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Newport News, Virginia, 23606
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Norcross, Georgia, 30071
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Oklahoma City, Oklahoma, 73103
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Old Point Station, South Carolina, 29707
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Ormond Beach, Florida, 32174
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Pensacola, Florida, 32503
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Peoria, Arizona, 85381
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Phoenix, Arizona, 85018
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Poway, California, 92064
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Reno, Nevada, 89503
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Richmond, Virginia, 23225
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Richmond, Virginia, 23230
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Rincon, Georgia, 31326
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Rock Hill, South Carolina, 29732
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Rolling Hills Estates, California, 90274
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Sacramento, California, 95821
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Saint Charles, Missouri, 63301
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San Antonio, Texas, 78229
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Seneca, South Carolina, 29678
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Spartanburg, South Carolina, 29303
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St Louis, Missouri, 63141
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Tacoma, Washington, 98405
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Tamarac, Florida, 33321
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Tampa, Florida, 33603
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Union, South Carolina, 29379
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Wilmington, North Carolina, 28401
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Winter Park, Florida, 32789
Research Site
Woodbury, Minnesota, 55125

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About this study

Official title: A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Read the detailed description

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Conditions: COPD
Being tested: BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, BFF MDI 320/9.6 μg
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.

BGF MDI 320/14.4/9.6 μgDrug
Also called BGF MDI
Budesonide, Glycopyrronium, and Formoterol Fumarate
GFF MDI 14.4/9.6 μgDrug
Also called GFF MDI
Glycopyrronium and Formoterol Fumarate
BFF MDI 320/9.6 μgDrug
Also called BFF MDI
Budesonide and Formoterol Fumarate

Study groups in NCT02536508
Study group	Role	What they receive
BGF MDI (PT010) 320/14.4/9.6 μg	Experimental	Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI) Receives: Drug: BGF MDI 320/14.4/9.6 μg
GFF MDI (PT003) 14.4/9.6 μg	Experimental	Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI) Receives: Drug: GFF MDI 14.4/9.6 μg
BFF MDI (PT009) 320/9.6 μg	Experimental	Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI) Receives: Drug: BFF MDI 320/9.6 μg

What is being measured

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

Percent Change From Baseline in BMD of the Lumbar Spine
Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
Measured: at week 52
Change From Baseline in the LOCS III (P) Score at Week 52
Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.
Measured: at week 52

Timeline

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

10 Aug 201512 Sep 2017

First posted1 Sep 2015 (estimated)
Study start10 Aug 2015
Primary completion12 Sep 2017
Study completion12 Sep 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 COPDStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 627 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02536508
Sponsor's protocol ID: PT010008
Status last verified: Jan 2021
First submitted: 27 Aug 2015
Last updated: 26 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Publications

Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
PubMed 35815359

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 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT02536508
Acronym / sponsor ID: PT010008
Conditions: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 627 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 10 Aug 2015 (actual)
Primary completion: 12 Sep 2017 (actual)
Study completion: 12 Sep 2017 (actual)
First posted: 1 Sep 2015 (estimated)
Results: Posted 26 Feb 2021

Clinical summary

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

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
BGF MDI (PT010) 320/14.4/9.6 μg	Experimental	Drug: BGF MDI 320/14.4/9.6 μgBudesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)
GFF MDI (PT003) 14.4/9.6 μg	Experimental	Drug: GFF MDI 14.4/9.6 μgGlycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)
BFF MDI (PT009) 320/9.6 μg	Experimental	Drug: BFF MDI 320/9.6 μgBudesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)

Who may qualify

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

Key inclusion criteria (1 listed)

Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)

Key exclusion criteria (1 listed)

Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery

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
BGF MDI 320/14.4/9.6 μgAlso: BGF MDIBudesonide, Glycopyrronium, and Formoterol Fumarate	Drug	BGF MDI (PT010) 320/14.4/9.6 μg
GFF MDI 14.4/9.6 μgAlso: GFF MDIGlycopyrronium and Formoterol Fumarate	Drug	GFF MDI (PT003) 14.4/9.6 μg
BFF MDI 320/9.6 μgAlso: BFF MDIBudesonide and Formoterol Fumarate	Drug	BFF MDI (PT009) 320/9.6 μg

Primary outcome

Percent Change From Baseline in BMD of the Lumbar Spine
Time frame: at week 52
Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
Change From Baseline in the LOCS III (P) Score at Week 52
Time frame: at week 52
Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.

Results and safety

Results posted to the registry on 26 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BGF MDI 320/14.4/9.6 ug	194	142
GFF MDI 14.4/9.6 ug	174	130
BFF MDI 320/9.6 ug	88	65

Primary outcome: Percent Change From Baseline in BMD of the Lumbar Spine

Time frame: at week 52. Least squares mean (95% Confidence Interval). Unit: Percentage

Measure	BGF MDI 320/14.4/9.6 ug n = 128	GFF MDI 14.4/9.6 ug n = 123	BFF MDI 320/9.6 ug n = 57
Value	-0.093 (-0.739 to 0.557)	0.379 (-0.28 to 1.042)	-0.120 (-1.087 to 0.857)

Population analysed: BMD Population was defined as all evaluable subjects in the Safety Population who had a baseline BMD assessment and at least 1 on-treatment BMD assessment. Subjects were analyzed according to actual study drug received.

Primary outcome: Change From Baseline in the LOCS III (P) Score at Week 52

Time frame: at week 52. Least squares mean (95% Confidence Interval). Unit: P-Score

Measure	BGF MDI 320/14.4/9.6 ug n = 132	GFF MDI 14.4/9.6 ug n = 125	BFF MDI 320/9.6 ug n = 54
Value	0.153 (0.079 to 0.227)	.026 (-0.055 to 0.106)	0.022 (-0.090 to 0.135)

Population analysed: Ophthalmologic Population was defined as all evaluable subjects in the Safety Population who had a baseline ophthalmologic assessment and at least 1 on-treatment ophthalmologic assessment. Subjects were analyzed according to actual study drug received.

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. Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call up to approximately 54 weeks.. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BGF MDI 320/14.4/9.6 ug	33 of 194 (17%)	62 of 194 (32%)	3 of 194
GFF MDI 14.4/9.6 ug	22 of 174 (12.6%)	51 of 174 (29.3%)	1 of 174
BFF MDI 320/9.6 ug	7 of 88 (8%)	30 of 88 (34.1%)	0 of 88

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35815359Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
PT010008-01\_Protocol\_Version\_2.0\_REDACTED.pdfLink provided by the sponsor.
Individual participant dataSharing planned: Yes

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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.

Colin Reisner study director

Pearl Therapeutics

Paul Dorinsky, MD study director

Pearl Therapeutics

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg and BFF MDI 320/9.6 μg in people with COPD, run by Pearl Therapeutics, Inc. at 64 sites 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 1 inclusion and 1 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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Feb 2021). 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?

Percent Change From Baseline in BMD of the Lumbar Spine (time frame: at week 52). The study lists 2 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 NCT02536508, 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 26 Feb 2021.