COPDPhase 3NCT02643082
A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
A Phase 3 study testing GFF MDI (PT003) 14.4/9.6μg in people with COPD, run by Pearl Therapeutics, Inc. at 1 site in Belgium.
Trial summary
Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance With Moderate to Severe COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- GFF MDI (PT003) 14.4/9.6μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Dec 2015to 26 Jan 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
- 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 an acceptable method of contraception
- 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 FEV1/FVC ratio of <70% and FEV1 must be 30% to 80% before predicted normal value, calculated using 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.
- Please refer to the study protocol for the complete inclusion criteria list.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance With Moderate to Severe COPD.
Read the detailed description
Enrolled patients with COPD who were randomized to receive either PT003 MDI or Placebo MDI first and then crossed over to receive the opposite intervention. The study consisted of 2 treatment periods of 14 days separated by a washout period of 5-21 days.
- Conditions
- COPD
- Being tested
- GFF MDI (PT003) 14.4/9.6μg, Placebo MDI
- 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.
GFF MDI (PT003) 14.4/9.6μgDrug
Also called GFF
Glycopyrronium and Formoterol Fumarate
Placebo MDIDrug
Also called Placebo
Comparator: Placebo MDI which contains no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| GFF MDI, 14.4/9.6μg | Experimental | Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Receives: Drug: GFF MDI (PT003) 14.4/9.6μg |
| Placebo MDI | Placebo comparator | Placebo Metered Dose Inhaler (MDI) Receives: Drug: Placebo MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Airway Volume (siVaw)
Specific image-based airway volume. Average across lobe, adjusted for lobe volume
Measured: Day 15
Specific Airway Resistance (siRaw)
Specific image-based airway resistance. Average across lobes, adjusted for lobe volume
Measured: Day 15
Secondary outcomes (4)
Airway Resistance (iRaw)
iRaw represents the airway resistance, averaged across lobes, without correction for lung lobe volume
Measured: Day 15
Airway Volume (iVaw)
iVaw represents the airway Volume, averaged across lobes, without correction for lung lobe volume
Measured: Day 15
Change From Baseline in FEV1 (L) at Day 15
Change from baseline in Forced Expiratory Volume at 1 second
Measured: Baseline and Day 15
Change From Baseline in FRC (L) at Day 15
Change from baseline in Functional Residual Capacity
Measured: Baseline and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study start23 Dec 2015
- Primary completion26 Jan 2017
- Study completion26 Jan 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 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
- NCT02643082
- Sponsor's protocol ID
- PT003018
- Status last verified
- Feb 2019
- First submitted
- 10 Dec 2015
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.
Publications
De Backer W, De Backer J, Vos W, Verlinden I, Van Holsbeke C, Clukers J, Hajian B, Siddiqui S, Jenkins M, Reisner C, Martin UJ. A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Aug 30;13:2673-2684. doi: 10.2147/COPD.S171707. eCollection 2018.
PubMed 30214185
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 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, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
- ClinicalTrials.gov ID
- NCT02643082
- Acronym / sponsor ID
- PT003018
- Conditions
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2015 (actual)
- Primary completion
- 26 Jan 2017 (actual)
- Study completion
- 26 Jan 2017 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Posted 19 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance With Moderate to Severe COPD.
Detailed description
Enrolled patients with COPD who were randomized to receive either PT003 MDI or Placebo MDI first and then crossed over to receive the opposite intervention. The study consisted of 2 treatment periods of 14 days separated by a washout period of 5-21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GFF MDI, 14.4/9.6μg | Experimental | Drug: GFF MDI (PT003) 14.4/9.6μgGlycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) |
| Placebo MDI | Placebo comparator | Drug: Placebo MDIPlacebo Metered Dose Inhaler (MDI) |
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 an acceptable method of contraception
- 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 FEV1/FVC ratio of <70% and FEV1 must be 30% to 80% before predicted normal value, calculated using NHANES III reference equations.
Key exclusion criteria (8 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 |
|---|---|---|
| GFF MDI (PT003) 14.4/9.6μgAlso: GFFGlycopyrronium and Formoterol Fumarate | Drug | GFF MDI, 14.4/9.6μg |
| Placebo MDIAlso: PlaceboComparator: Placebo MDI which contains no active ingredients | Drug | Placebo MDI |
Primary outcome
Specific Airway Volume (siVaw)
Time frame: Day 15
Specific image-based airway volume. Average across lobe, adjusted for lobe volume
Specific Airway Resistance (siRaw)
Time frame: Day 15
Specific image-based airway resistance. Average across lobes, adjusted for lobe volume
4 secondary outcomes
Airway Resistance (iRaw)
Time frame: Day 15
Airway Volume (iVaw)
Time frame: Day 15
Change From Baseline in FEV1 (L) at Day 15
Time frame: Baseline and Day 15
Change From Baseline in FRC (L) at Day 15
Time frame: Baseline and Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30214185De Backer W, De Backer J, Vos W, Verlinden I, Van Holsbeke C, Clukers J, Hajian B, Siddiqui S, Jenkins M, Reisner C, Martin UJ. A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Aug 30;13:2673-2684. doi: 10.2147/COPD.S171707. eCollection 2018.
- Protocol with updated PDFA coverpageLink provided by the sponsor.
- Updated version per comments from CT.govLink provided by the sponsor.
- Updated version per CT.gov commentsLink provided by the sponsor.
- Updated version per CT.gov commentsLink provided by the sponsor.
- Updated version per comments from CT.govLink provided by the sponsor.
- Updated version per CT.gov commentsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GFF MDI (PT003) 14.4/9.6μg in people with COPD, run by Pearl Therapeutics, Inc. at 1 site 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 8 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 19 Mar 2019. 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 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. Some participants in this study may receive a placebo. 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 19 Mar 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 Airway Volume (siVaw) (time frame: 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?
On the ClinicalTrials.gov record for NCT02643082, 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 19 Mar 2019.