Chronic Obstructive Pulmonary DiseasePhase 2PT009001NCT02196077

Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg and BFF MDI 80/9.6 μg in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg and BFF MDI 80/9.6 μg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 17 sitesUnited States
Study dates: 1 Aug 2014to 1 Mar 2015
Phase: Phase 2
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

Informed Consent Form (ICF) prior to any study related procedures
COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
Tobacco Use: Current or former smokers with a history of at least 10 pack years of cigarette smoking
Women of non-childbearing potential or medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
Severity of Disease: Subjects with an established clinical history of COPD and severity defined as: FEV1/forced vital capacity (FVC) ratio of <0.70; At Screening (Visit 1a/b), post bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III (Third National Health and Nutrition Examination Survey) reference equations; the measured FEV1 must also be ≥30% of predicted normal value; at Visit 2, the average of the 60 minutes and 30 minutes pre dose FEV1 assessments must be <80% predicted normal value calculated using NHANES III reference equations
Screening clinical laboratory tests must be acceptable to the Investigator
Screening ECG must be acceptable to the Investigator
Chest x ray or computerized tomography (CT) scan within 6 months prior to Visit 1a must be acceptable to the Investigator.

Who cannot join

Significant diseases other than COPD, ie., 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
Pregnancy, nursing female subjects, or subjects trying to conceive, or not using medically acceptable form of contraception
Asthma: Subjects who have a primary diagnosis of asthma (Note: Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis).
Alpha 1 Antitrypsin Deficiency: Subjects who have alpha 1 antitrypsin deficiency as the cause of COPD -Active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea (ie., in the opinion of the Investigator severity of the disorder would impact the conduct of the study)-
Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
Poorly Controlled COPD

Show all 13Show fewer

History of ECG abnormalities
Cancer not in complete remission for at least 5 years
Clinically significant, symptomatic prostatic hypertrophy
Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
Clinically significant bladder neck obstruction or urinary retention
Inadequately treated glaucoma
History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Pearl Investigative Site
Charlotte, North Carolina
Pearl Investigative Site
Cincinnati, Ohio
Pearl Investigative Site
Clearwater, Florida
Pearl Investigative Site
Columbus, Ohio
Pearl Investigative Site
Dublin, Ohio
Pearl Investigative Site
Easley, South Carolina
Pearl Investigative Site
Edina, Minnesota
Pearl Investigative Site
Greenville, South Carolina
Pearl Investigative Site
Medford, Oregon
Pearl Investigative Site
Minneapolis, Minnesota
Pearl Investigative Site
Panama City, Florida
Pearl Investigative Site
Rolling Hills Estates, California
Pearl Investigative Site
Saint Charles, Missouri
Pearl Investigative Site
Spartanburg, South Carolina
Pearl Investigative Site
Tampa, Florida
Pearl Investigative Site
Winter Park, Florida
Pearl Investigative Site
Woodbury, Minnesota

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Chronic Dosing (28 Days), Four Period, Five Treatment, Incomplete Block, Multi Center, Crossover Study to Assess the Efficacy and Safety of PT009, PT008, and PT005 in Subjects With Moderate to Severe COPD

This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, BFF MDI 80/9.6 μg, BD MDI 320 μg, FF MDI 9.6 μg
Keywords: Budesonide and formoterol inhalation aerosol
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.

BFF MDI 320/9.6 μgDrug
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 160/9.6 μgDrug
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 80/9.6 μgDrug
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BD MDI 320 μgDrug
Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
FF MDI 9.6 μgDrug
Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)

Study groups in NCT02196077
Study group	Role	What they receive
BFF MDI 320/9.6 μg	Experimental	Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID) Receives: Drug: BFF MDI 320/9.6 μg
BFF MDI 160/9.6 μg	Experimental	Budesonide and formoterol fumarate metered dose inhaler (BFF MDI)160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID) Receives: Drug: BFF MDI 160/9.6 μg
BFF MDI 80/9.6 μg	Experimental	Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID) Receives: Drug: BFF MDI 80/9.6 μg
BD MDI 320 μg	Experimental	Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID) Receives: Drug: BD MDI 320 μg
FF MDI 9.6 μg	Experimental	Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID) Receives: Drug: FF MDI 9.6 μg

What is being measured

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

FEV1 AUC0-12 on Day 29
Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)
Measured: Day 29

Secondary outcomes (7)

Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days
Measured: Over 28 days
Peak Change From Baseline in FEV1 (in Liters) Day 15
Measured: Day 15
Peak Change From Baseline in FEV1 (in Liters) Day 29
Measured: Day 29
Peak Change From Baseline in FEV1 on Day 1
Measured: Day 1
Forced Vital Capacity (FVC) AUC0-12 on Day 29
Measured: Day 29
Transition Dyspnea Index (TDI) Focal Score on Day 29
Min/Max Range of TDI scale -9 (major deterioration) to +9 (major improvement)
Measured: Day 29
Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment
Measured: Visit 12-13 (7 days)

Timeline

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

1 Aug 20141 Mar 2015

First posted21 Jul 2014 (estimated)
Study start1 Aug 2014
Primary completion1 Mar 2015
Study completion1 Mar 2015

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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02196077
Sponsor's protocol ID: PT009001
Acronym: PT009001
Status last verified: May 2018
First submitted: 16 Jul 2014
Last updated: 20 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

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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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Chronic Dosing (28 Days), Four Period, Five Treatment, Incomplete Block, Multi Center, Crossover Study to Assess the Efficacy and Safety of PT009, PT008, and PT005 in Subjects With Moderate to Severe COPD
ClinicalTrials.gov ID: NCT02196077
Acronym / sponsor ID: PT009001 / PT009001
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Budesonide and formoterol inhalation aerosol
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 1 Aug 2014 (actual)
Primary completion: 1 Mar 2015 (actual)
Study completion: 1 Mar 2015 (actual)
First posted: 21 Jul 2014 (estimated)
Results: Posted 9 May 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
BFF MDI 320/9.6 μg	Experimental	Drug: BFF MDI 320/9.6 μgBudesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 160/9.6 μg	Experimental	Drug: BFF MDI 160/9.6 μgBudesonide and formoterol fumarate metered dose inhaler (BFF MDI)160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BFF MDI 80/9.6 μg	Experimental	Drug: BFF MDI 80/9.6 μgBudesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
BD MDI 320 μg	Experimental	Drug: BD MDI 320 μgBudesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
FF MDI 9.6 μg	Experimental	Drug: FF MDI 9.6 μgFormoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)

Who may qualify

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

Key inclusion criteria (8 listed)

Informed Consent Form (ICF) prior to any study related procedures
COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
Tobacco Use: Current or former smokers with a history of at least 10 pack years of cigarette smoking
Women of non-childbearing potential or medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
Severity of Disease: Subjects with an established clinical history of COPD and severity defined as: FEV1/forced vital capacity (FVC) ratio of <0.70; At Screening (Visit 1a/b), post bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III (Third National Health and Nutrition Examination Survey) reference equations; the measured FEV1 must also be ≥30% of predicted normal value; at Visit 2, the average of the 60 minutes and 30 minutes pre dose FEV1 assessments must be <80% predicted normal value calculated using NHANES III reference equations

Key exclusion criteria (13 listed)

Significant diseases other than COPD, ie., 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
Pregnancy, nursing female subjects, or subjects trying to conceive, or not using medically acceptable form of contraception
Asthma: Subjects who have a primary diagnosis of asthma (Note: Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis).
Alpha 1 Antitrypsin Deficiency: Subjects who have alpha 1 antitrypsin deficiency as the cause of COPD -Active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea (ie., in the opinion of the Investigator severity of the disorder would impact the conduct of the study)-
Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study

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
BFF MDI 320/9.6 μgBudesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)	Drug	BFF MDI 320/9.6 μg
BFF MDI 160/9.6 μgBudesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)	Drug	BFF MDI 160/9.6 μg
BFF MDI 80/9.6 μgBudesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)	Drug	BFF MDI 80/9.6 μg
BD MDI 320 μgBudesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)	Drug	BD MDI 320 μg
FF MDI 9.6 μgFormoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)	Drug	FF MDI 9.6 μg

Primary outcome

FEV1 AUC0-12 on Day 29
Time frame: Day 29
Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)

7 secondary outcomes

Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days
Time frame: Over 28 days
Peak Change From Baseline in FEV1 (in Liters) Day 15
Time frame: Day 15
Peak Change From Baseline in FEV1 (in Liters) Day 29
Time frame: Day 29
Peak Change From Baseline in FEV1 on Day 1
Time frame: Day 1
Forced Vital Capacity (FVC) AUC0-12 on Day 29
Time frame: Day 29
Transition Dyspnea Index (TDI) Focal Score on Day 29
Time frame: Day 29
Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment
Time frame: Visit 12-13 (7 days)

Results and safety

Results posted to the registry on 9 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects	180	133

Primary outcome: FEV1 AUC0-12 on Day 29

Time frame: Day 29. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	BFF MDI 320/9.6 ug n = 148	BFF MDI 160/9.6 ug n = 98	BFF MDI 80/9.6 ug n = 96	BD MDI 320 ug n = 99	FF MDI 9.6 ug n = 142
Value	0.231 (0.197 to 0.266)	0.197 (0.158 to 0.236)	0.205 (0.165 to 0.244)	0.011 (-0.028 to 0.050)	0.176 (0.141 to 0.210)

Population analysed: MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BFF MDI 320/9.6 ug	4 of 155 (2.6%)	12 of 155 (7.7%)	Not reported
BFF MDI 160/9.6 ug	2 of 106 (1.9%)	2 of 106 (1.9%)	Not reported
BFF MDI 80/9.6 ug	3 of 103 (2.9%)	5 of 103 (4.9%)	Not reported
BD MDI 320 ug	4 of 108 (3.7%)	8 of 108 (7.4%)	Not reported
FF MDI 9.6 ug	2 of 157 (1.3%)	8 of 157 (5.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.

Shahid Siddiqui, MD, MHSA study director

Pearl Therapeutics, Inc.

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

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 13 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 May 2017). 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?

FEV1 AUC0-12 on Day 29 (time frame: Day 29). 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 NCT02196077.

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 20 Jun 2018.