COPDPhase 3NCT03262012
Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler®
A Phase 3 study testing BGF MDI (PT010), GFF MDI (PT003) and BFF MDI (PT009) in people with COPD, run by Pearl Therapeutics, Inc. at 79 sites in Japan.
Trial summary
A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler® 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 (PT010), GFF MDI (PT003) and BFF MDI (PT009)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 79 sitesJapan
- Study dates
- 9 Aug 2016to 15 Jun 2018
- 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.
- Subjects must have agreed to participate and complete the lead-in Study PT010006.
- 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.
- Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
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- Required COPD maintenance therapy:
- All Subjects must have been on two or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA and/or scheduled SAMA are considered inhaled maintenance therapies.
- Please refer to the study protocol for the complete inclusion criteria list.
Who cannot join
- Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- 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 been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period
- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period
- Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
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- Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
- Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.
- Please refer to the study protocol for the complete exclusion criteria list.
Trial locations and contacts
79 sites in 1 country.
79 sites in 1 country
Japan79 sites
Research Site
Bunkyō City, 113-8431
Research Site
Chūōku, 103-0022
Research Site
Chūōku, 104-0031
Research Site
Chūōku, 104-8560
Research Site
Date-gun, 969-1793
Research Site
Fukuoka, 814-0180
Research Site
Ginowan-shi, 901-2214
Research Site
Hakata-shi, 812-0033
Research Site
Hamamatsu, 430-0906
Research Site
Hamamatsu, 430-8525
Research Site
Hamamatsu, 434-8511
Research Site
Higashiokitama-gun, 992-0601
Research Site
Higashiosaka-shi, 577-0843
Research Site
Himeji-shi, 672-8064
Research Site
Hirakata-shi, 573-1191
Research Site
Iizuka-shi, 820-8505
Research Site
Iwata-shi, 438-8550
Research Site
Izumo-shi, 693-0068
Research Site
Izumo-shi, 693-8501
Research Site
Kagoshima, 892-0847
Research Site
Kahoku-gun, 920-0293
Research Site
Kakogawa-shi, 675-0023
Research Site
Kasaoka-shi, 714-0081
Research Site
Kasuga-shi, 816-0813
Research Site
Kishiwada-shi, 596-8501
Research Site
Kiyose-shi, 204-0023
Research Site
Kobe, 650-0017
Research Site
Koga-shi, 811-3195
Research Site
Kurashiki-shi, 711-0921
Research Site
Kure-shi, 737-0193
Research Site
Kure-shi, 737-8505
Research Site
Kyoto, 601-1495
Research Site
Kyoto, 601-8206
Research Site
Kyoto, 602-8026
Research Site
Kyoto, 607-8062
Research Site
Kyoto, 615-8087
Research Site
Maebashi, 371-0054
Research Site
Matsumoto-shi, 390-0872
Research Site
Matsusaka-shi, 515-0073
Research Site
Meguro-ku, 153-8515
Research Site
Mitaka-shi, 181-8611
Research Site
Mizunami-shi, 509-6134
Research Site
Nagaoka-shi, 940-2085
Research Site
Nagoya, 454-8502
Research Site
Nagoya, 457-8511
Research Site
Nagoya, 466-8560
Research Site
Naha, 902-0061
Research Site
Nishishirakawa-gun, 969-0213
Research Site
Obihiro-shi, 080-0013
Research Site
Ogaki-shi, 503-8502
Research Site
Ōita, 870-0921
Research Site
Ōita, 870-0951
Research Site
Okinawa-shi, 904-2143
Research Site
Ookawa-shi, 831-0016
Research Site
Osaka, 543-0035
Research Site
Osakasayama-shi, 589-8511
Research Site
Ōtsu, 520-0804
Research Site
Sakaide-shi, 762-8550
Research Site
Sakaishi, 591-8555
Research Site
Sapporo, 001-0901
Research Site
Sapporo, 064-0915
Research Site
Sendai, 980-8574
Research Site
Sendai, 983-0824
Research Site
Sendai, 984-8560
Research Site
Seto-shi, 489-8642
Research Site
Shinagawa-ku, 142-8666
Research Site
Shinjuku-ku, 162-0052
Research Site
Shizuoka, 420-8630
Research Site
Suita-shi, 564-0013
Research Site
tabashi City, 173-8610
Research Site
Tachikawa-shi, 190-0014
Research Site
Takamatsu, 760-8538
Research Site
Toon-shi, 791-0281
Research Site
Toshima-ku, 171-0014
Research Site
Toyama, 930-0194
Research Site
Toyama, 931-8533
Research Site
Toyama, 939-8282
Research Site
Yanagawa-shi, 832-0059
Research Site
Yokohama, 236-0004
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With Symbicort® Turbuhaler® as an Active Control
A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®
Read the detailed description
This is a multicenter, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week period in Japanese subjects with moderate to very severe COPD who remain symptomatic on maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more maintenance bronchodilators.
- Conditions
- COPD
- Being tested
- BGF MDI (PT010), GFF MDI (PT003), BFF MDI (PT009), Symbicort® Turbohaler® Inhalation Powder
- 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 (PT010)Drug
Also called BGF
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
GFF MDI (PT003)Drug
Also called GFF
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
BFF MDI (PT009)Drug
Also called BFF
Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
Symbicort® Turbohaler® Inhalation PowderDrug
Also called Symbicort
Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
| Study group | Role | What they receive |
|---|---|---|
| BGF MDI (PT010) | Experimental | Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010 Receives: Drug: BGF MDI (PT010) |
| GFF MDI (PT003) | Experimental | Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003 Receives: Drug: GFF MDI (PT003) |
| BFF MDI (PT009) | Experimental | Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009 Receives: Drug: BFF MDI (PT009) |
| Symbicort® Turbohaler® Inhalation Powder | Active comparator | Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler Receives: Drug: Symbicort® Turbohaler® Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values
Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values
Measured: 28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Measured: 28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Measured: 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start9 Aug 2016
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
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
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul M. Dorinsky, MD, Study director, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262012
- Sponsor's protocol ID
- PT010007
- Status last verified
- Apr 2020
- First submitted
- 17 Feb 2016
- Last updated
- 13 May 2020
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With Symbicort® Turbuhaler® as an Active Control
- ClinicalTrials.gov ID
- NCT03262012
- Acronym / sponsor ID
- PT010007
- Conditions
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 13 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®
Detailed description
This is a multicenter, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week period in Japanese subjects with moderate to very severe COPD who remain symptomatic on maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more maintenance bronchodilators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BGF MDI (PT010) | Experimental | Drug: BGF MDI (PT010)Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010 |
| GFF MDI (PT003) | Experimental | Drug: GFF MDI (PT003)Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003 |
| BFF MDI (PT009) | Experimental | Drug: BFF MDI (PT009)Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009 |
| Symbicort® Turbohaler® Inhalation Powder | Active comparator | Drug: Symbicort® Turbohaler® Inhalation PowderBudesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Given their signed written informed consent to participate.
- Subjects must have agreed to participate and complete the lead-in Study PT010006.
- 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.
Key exclusion criteria (9 listed)
- Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- 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 been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period
- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period
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 (PT010)Also: BGFBudesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010 | Drug | BGF MDI (PT010) |
| GFF MDI (PT003)Also: GFFGlycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003 | Drug | GFF MDI (PT003) |
| BFF MDI (PT009)Also: BFFBudesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009 | Drug | BFF MDI (PT009) |
| Symbicort® Turbohaler® Inhalation PowderAlso: SymbicortBudesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler | Drug | Symbicort® Turbohaler® Inhalation Powder |
Primary outcome
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values
Time frame: 28 Weeks
Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Time frame: 28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Time frame: 28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- 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.
- 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.
Paul M. Dorinsky, MD study director
Pearl Therapeutics, Inc.
79 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 (PT010), GFF MDI (PT003) and BFF MDI (PT009) in people with COPD, run by Pearl Therapeutics, Inc. at 79 sites in Japan.
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 9 inclusion and 9 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 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Japan. 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 13 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?
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values (time frame: 28 Weeks). 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 NCT03262012, 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 13 May 2020.