COPD, Chronic Obstructive Pulmonary DiseasePhase 3NCT02937584
A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD
A Phase 3 study testing GP MDI (PT001) 14.4 μg and FF MDI (PT005) 9.6 μg in people with COPD, Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 2 sites in Belgium.
Trial summary
To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- GP MDI (PT001) 14.4 μg and FF MDI (PT005) 9.6 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesBelgium
- Study dates
- 29 Dec 2016to 28 May 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
- 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 urine pregnancy test at Visit 1, and agrees to use acceptable contraceptive methods used consistently and correctly
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- At Visit 1, FEV1/FVC ratio must be <0.70
- At Visit 1, post-bronchodilator FEV1must be >30% and <80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations.
Who cannot join
- Significant diseases other than COPD, i.e., disease or condition 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 run-in period (Visit 1 to Visit 2).
- 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 run-in period (Visit 1 to Visit 2).
- Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated.
- Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.
To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.
- Being tested
- GP MDI (PT001) 14.4 μg, FF MDI (PT005) 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.
GP MDI (PT001) 14.4 μgDrug
Glycopyrronium
FF MDI (PT005) 9.6 μgDrug
Formoterol Fumarate
| Study group | Role | What they receive |
|---|---|---|
| GP MDI (PT001) 14.4 μg | Experimental | Glycopyrronium Receives: Drug: GP MDI (PT001) 14.4 μg |
| FF MDI (PT005) 9.6 μg | Experimental | Formoterol Fumarate Receives: Drug: FF MDI (PT005) 9.6 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Image-Based Airway Volume (siVaw)
Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline
Measured: Baseline, Day 15
Specific Image-based Airway Resistance (siRaw)
Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.
Measured: Baseline, Day 15
Secondary outcomes (4)
Image-based Airway Volume (iVaw)
Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline.
Measured: Baseline, Day 15
Image-based Airway Resistance (iRaw)
Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline.
Measured: Baseline, Day 15
FEV1
FEV1 Change from baseline in Forced Expiratory Volume at 1 second.
Measured: Baseline, Day 15
Functional Residual Capacity (FRC)
Functional residual capacity (FRC). Ratio to baseline.
Measured: Baseline, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start29 Dec 2016
- Primary completion28 May 2018
- Study completion28 May 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.
- Other trials for COPD, 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chad Orevillo, Study director, Pearl Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937584
- Sponsor's protocol ID
- PT003019
- Status last verified
- Jun 2019
- First submitted
- 17 Oct 2016
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.
- ClinicalTrials.gov ID
- NCT02937584
- Acronym / sponsor ID
- PT003019
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 28 May 2018 (actual)
- Study completion
- 28 May 2018 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP MDI (PT001) 14.4 μg | Experimental | Drug: GP MDI (PT001) 14.4 μgGlycopyrronium |
| FF MDI (PT005) 9.6 μg | Experimental | Drug: FF MDI (PT005) 9.6 μgFormoterol Fumarate |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 urine pregnancy test at Visit 1, and agrees to use acceptable contraceptive methods used consistently and correctly
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- At Visit 1, FEV1/FVC ratio must be <0.70
- At Visit 1, post-bronchodilator FEV1must be >30% and <80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations.
Key exclusion criteria (7 listed)
- Significant diseases other than COPD, i.e., disease or condition 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 run-in period (Visit 1 to Visit 2).
- 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 run-in period (Visit 1 to Visit 2).
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 |
|---|---|---|
| GP MDI (PT001) 14.4 μgGlycopyrronium | Drug | GP MDI (PT001) 14.4 μg |
| FF MDI (PT005) 9.6 μgFormoterol Fumarate | Drug | FF MDI (PT005) 9.6 μg |
Primary outcome
Specific Image-Based Airway Volume (siVaw)
Time frame: Baseline, Day 15
Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline
Specific Image-based Airway Resistance (siRaw)
Time frame: Baseline, Day 15
Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.
4 secondary outcomes
Image-based Airway Volume (iVaw)
Time frame: Baseline, Day 15
Image-based Airway Resistance (iRaw)
Time frame: Baseline, Day 15
FEV1
Time frame: Baseline, Day 15
Functional Residual Capacity (FRC)
Time frame: Baseline, Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Chad Orevillo study director
Pearl Therapeutics
2 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 GP MDI (PT001) 14.4 μg and FF MDI (PT005) 9.6 μg in people with COPD, Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 2 sites in Belgium.
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 7 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 24 Jul 2019). 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?
Specific Image-Based Airway Volume (siVaw) (time frame: Baseline, Day 15). 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?
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 24 Jul 2019.