Chronic Obstructive Pulmonary DiseasePhase 3NCT03081247
To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
A Phase 3 study testing BGF 320/14.4/9.6 µg MDI and BFF 320/9.6 µg in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc..
Trial summary
This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- BGF 320/14.4/9.6 µg MDI and BFF 320/9.6 µg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2018to 7 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Signed Informed Consent
- Subjects with an established clinical history of COPD
- Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value
- All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking
- Women of Non-childbearing potential
- Women of childbearing potential and sexually active agree to prevent pregnancy by using acceptable contraceptive methods consistently
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
- Current diagnosis of asthma
- Uncontrolled sleep apnea
- Other Serious Respiratory Disorders
- Hospitalized due to poorly controlled COPD within 6 weeks
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- Poorly Controlled COPD
- Immune deficiency and/or severe neurological disorders affecting control of the upper airway
- Hypersensitivity to β2-agonists, corticosteroids, or muscarinic anticholinergics
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, 12-Week, Chronic Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.
Read the detailed description
This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BGF 320/14.4/9.6 µg MDI, BFF 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 320/14.4/9.6 µg MDIDrug
Also called PT010
Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
BFF 320/9.6 µgDrug
Also called PT009
Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)
| Study group | Role | What they receive |
|---|---|---|
| BGF 320/14.4/9.6 µg MDI BID | Experimental | Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI) Receives: Drug: BGF 320/14.4/9.6 µg MDI |
| BFF 320/9.6 µg MDI BID | Experimental | Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI) Receives: Drug: BFF 320/9.6 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)
Measured: Week 12
Secondary outcomes (7)
Change from baseline in morning pre-dose trough FEV1
Measured: Week 12
Peak change from baseline in inspiratory capacity
Measured: Week 12
Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)
Measured: Week 12
Time to first clinically important deterioration (CID) in COPD
Measured: 12 weeks
Change from baseline in average daily rescue Ventolin HFA use
Measured: 12 weeks
Peak change from baseline in FEV1
Measured: Week 12
Time to onset of action
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start16 Apr 2018 (estimated)
- Primary completion7 Dec 2018 (estimated)
- Study completion7 Dec 2018 (estimated)
Why it stopped: Internal Study team decision not to proceed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Reisner, MD, Study director, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081247
- Sponsor's protocol ID
- PT010017
- Status last verified
- Jul 2018
- First submitted
- 6 Mar 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, 12-Week, Chronic Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03081247
- Acronym / sponsor ID
- PT010017
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal Study team decision not to proceed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2018 (estimated)
- Primary completion
- 7 Dec 2018 (estimated)
- Study completion
- 7 Dec 2018 (estimated)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.
Detailed description
This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGF 320/14.4/9.6 µg MDI BID | Experimental | Drug: BGF 320/14.4/9.6 µg MDIBudesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI) |
| BFF 320/9.6 µg MDI BID | Experimental | Drug: BFF 320/9.6 µgBudesonide and Formoterol Fumarate metered dose inhaler (BFF MDI) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent
- Subjects with an established clinical history of COPD
- Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value
- All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening
- 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
- Current diagnosis of asthma
- Uncontrolled sleep apnea
- Other Serious Respiratory Disorders
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 320/14.4/9.6 µg MDIAlso: PT010Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI) | Drug | BGF 320/14.4/9.6 µg MDI BID |
| BFF 320/9.6 µgAlso: PT009Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI) | Drug | BFF 320/9.6 µg MDI BID |
Primary outcome
Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)
Time frame: Week 12
7 secondary outcomes
Change from baseline in morning pre-dose trough FEV1
Time frame: Week 12
Peak change from baseline in inspiratory capacity
Time frame: Week 12
Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)
Time frame: Week 12
Time to first clinically important deterioration (CID) in COPD
Time frame: 12 weeks
Change from baseline in average daily rescue Ventolin HFA use
Time frame: 12 weeks
Peak change from baseline in FEV1
Time frame: Week 12
Time to onset of action
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- 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.
Colin Reisner, MD study director
Pearl Therapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BGF 320/14.4/9.6 µg MDI and BFF 320/9.6 µg in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc..
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 7 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: withdrawn, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4) (time frame: Week 12). 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 2 Aug 2018.