Chronic Obstructive Pulmonary DiseasePhase 2NCT01587079

Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Phase 2 study testing PT003, PT001 and PT005 in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 19 sites in United States.

Completed

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

Official record

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Trial summary

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to 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?: PT003, PT001 and PT005
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 19 sitesUnited States
Study dates: Apr 2012to Oct 2012
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

Signed written informed consent
40 - 80 years of age
Clinical history of COPD with airflow limitation that is not fully reversible
Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods
Current/former smokers with at least a 10 pack-year history of cigarette smoking
A measured post-bronchodilator FEV1/FVC ratio of < or = 0.70
A measured post-bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
Able to change COPD treatment as required by protocol

Who cannot join

Women who are pregnant or lactating
Primary diagnosis of asthma
Alpha-1 antitrypsin deficiency as the cause of COPD
Active pulmonary diseases
Prior lung volume reduction surgery
Abnormal chest X-ray not due to the presence of COPD

Show all 11Show fewer

Hospitalized due to poorly controlled COPD within 3 months of Screening
Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
Cancer that has not been in complete remission for at least 5 years
Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
Other inclusion/exclusion criteria as defined in the protocol

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Pearl Investigative Site
Cincinnati, Ohio
Pearl Investigative Site
Clearwater, Florida, 33765
Pearl Investigative Site
Clearwater, Florida
Pearl Investigative Site
Fridley, Minnesota
Pearl Investigative Site
Glendale, Arizona
Pearl Investigative Site
Lafayette, Louisiana
Pearl Investigative Site
Medford, Oregon, 97504
Pearl Investigative Site
Medford, Oregon
Pearl Investigative Site
Morgantown, West Virginia
Pearl Investigative Site
North Dartmouth, Massachusetts
Pearl Investigative Site
Pensacola, Florida
Pearl Investigative Site
Rancho Mirage, California
Pearl Investigative Site
Rock Hill, South Carolina
Pearl Investigative Site
San Antonio, Texas
Pearl Investigative Site
Spartanburg, South Carolina, 29303
Pearl Investigative Site
St Louis, Missouri
Pearl Investigative Site
Summit, New Jersey
Pearl Investigative Site
Waterbury, Connecticut
Pearl Investigative Site
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: PT003, PT001, PT005, Tiotropium inhalation powder
Keywords: COPD
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.

PT003Drug
PT003 MDI administered as two puffs BID for 7 days
PT001Drug
PT001 MDI administered as two puffs BID for 7 days
PT005Drug
PT005 MDI administered as two puffs BID for 7 days
Tiotropium inhalation powderDrug
Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

Study groups in NCT01587079
Study group	Role	What they receive
PT003 (Dose 1)	Experimental	PT003 MDI Dose 1 Receives: Drug: PT003
PT003 (Dose 2)	Experimental	PT003 MDI Dose 2 Receives: Drug: PT003
PT003 (Dose 3)	Experimental	PT003 MDI Dose 3 Receives: Drug: PT003
PT003 (Dose 4)	Experimental	PT003 MDI Dose 4 Receives: Drug: PT003
PT003 (Dose 5)	Experimental	PT003 MDI Dose 5 Receives: Drug: PT003
PT001	Experimental	PT001 MDI Receives: Drug: PT001
PT005	Experimental	PT005 MDI Receives: Drug: PT005
Spiriva® Handihaler®	Active comparator	Tiotropium Bromide Receives: Drug: Tiotropium inhalation powder

What is being measured

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

FEV1 AUC 0-12 on Day 7
FEV1 AUC 0-12
Measured: Day 7

Secondary outcomes (13)

Peak Change From Baseline in FEV1 on Treatment Day 1
Peak change from Baseline in FEV1 on Treatment
Measured: Day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Time to onset of action (>10% improvement in FEV1)
Measured: Day 1
Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1
Proportion of subjects achieving >=12% improvement in FEV1
Measured: Day 1
Peak Change From Baseline in Inspiratory Capacity on Day 1
Peak change from baseline in Inspiratory Capacity
Measured: Day 1
Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7
Change from baseline in morning pre-dose trough FEV1
Measured: Day 7
Peak Change From Baseline in FEV1 on Day 7
Peak change from baseline in FEV1 Day 7
Measured: Day 7
Change From Baseline in Morning Pre-dose Trough IC on Day 7
Change from baseline in morning pre-dose trough IC
Measured: Day 7
Peak Change From Baseline IC on Day 7
Peak change from baseline IC
Measured: Day 7
Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7
Change from baseline at evening 12-hour post-dose trough FEV1
Measured: Day 7
Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7
Change from baseline in mean morning pre-dose daily peak flow readings
Measured: Day 7
Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7
Change from baseline in mean morning post-dose daily peak flow readings on
Measured: Day 7
Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7
Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)
Measured: Day 7
Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7
Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)
Measured: Day 7

Timeline

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

Apr 2012Oct 2012

First posted27 Apr 2012 (estimated)
Study startApr 2012
Primary completionSep 2012
Study completionOct 2012

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01587079
Sponsor's protocol ID: PT003005
Status last verified: May 2016
First submitted: 25 Apr 2012
Last updated: 30 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control
ClinicalTrials.gov ID: NCT01587079
Acronym / sponsor ID: PT003005
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Sep 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 27 Apr 2012 (estimated)
Results: Posted 30 Jun 2016

Clinical summary

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

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
PT003 (Dose 1)	Experimental	Drug: PT003PT003 MDI Dose 1
PT003 (Dose 2)	Experimental	Drug: PT003PT003 MDI Dose 2
PT003 (Dose 3)	Experimental	Drug: PT003PT003 MDI Dose 3
PT003 (Dose 4)	Experimental	Drug: PT003PT003 MDI Dose 4
PT003 (Dose 5)	Experimental	Drug: PT003PT003 MDI Dose 5
PT001	Experimental	Drug: PT001PT001 MDI
PT005	Experimental	Drug: PT005PT005 MDI
Spiriva® Handihaler®	Active comparator	Drug: Tiotropium inhalation powderTiotropium Bromide

Who may qualify

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

Key inclusion criteria (8 listed)

Signed written informed consent
40 - 80 years of age
Clinical history of COPD with airflow limitation that is not fully reversible
Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods
Current/former smokers with at least a 10 pack-year history of cigarette smoking

Key exclusion criteria (11 listed)

Women who are pregnant or lactating
Primary diagnosis of asthma
Alpha-1 antitrypsin deficiency as the cause of COPD
Active pulmonary diseases
Prior lung volume reduction surgery

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
PT003PT003 MDI administered as two puffs BID for 7 days	Drug	PT003 (Dose 1), PT003 (Dose 2), PT003 (Dose 3), PT003 (Dose 4), PT003 (Dose 5)
PT001PT001 MDI administered as two puffs BID for 7 days	Drug	PT001
PT005PT005 MDI administered as two puffs BID for 7 days	Drug	PT005
Tiotropium inhalation powderTaken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days	Drug	Spiriva® Handihaler®

Primary outcome

FEV1 AUC 0-12 on Day 7
Time frame: Day 7
FEV1 AUC 0-12

13 secondary outcomes

Peak Change From Baseline in FEV1 on Treatment Day 1
Time frame: Day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Time frame: Day 1
Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1
Time frame: Day 1
Peak Change From Baseline in Inspiratory Capacity on Day 1
Time frame: Day 1
Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7
Time frame: Day 7
Peak Change From Baseline in FEV1 on Day 7
Time frame: Day 7
Change From Baseline in Morning Pre-dose Trough IC on Day 7
Time frame: Day 7
Peak Change From Baseline IC on Day 7
Time frame: Day 7
Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7
Time frame: Day 7
Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7
Time frame: Day 7
Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7
Time frame: Day 7
Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7
Time frame: Day 7
Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7
Time frame: Day 7

Results and safety

Results posted to the registry on 30 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	159	120

Primary outcome: FEV1 AUC 0-12 on Day 7

Time frame: Day 7. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	GP MDI 18 μg (PT001) n = 57	GFF MDI 18/9.6 μg (PT003) n = 59	GFF/MDI 9/9.6 μg n = 52	GFF MDI BID 4.6/9.6 μg n = 57	GFF MDI 2.4/9.6 μg (PT003) n = 57	GFF MDI 1.2/9.6 μg (PT003) n = 60	FF MDI 9.6 μg n = 57	Spiriva 18 μg QD n = 60
Value	1.452 (1.415 to 1.489)	1.591 (1.554 to 1.628)	1.547 (1.509 to 1.585)	1.539 (1.502 to 1.575)	1.538 (1.502 to 1.575)	1.508 (1.472 to 1.545)	1.467 (1.430 to 1.505)	1.489 (1.453 to 1.525)

Population analysed: MITT

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GP MDI 18 μg (PT001)	1 of 66 (1.5%)	8 of 66 (12.1%)	Not reported
GFF MDI 18/9.6 μg (PT003)	1 of 71 (1.4%)	2 of 71 (2.8%)	Not reported
GFF MDI 9/9.6 μg (PT003)	0 of 70 (0%)	8 of 70 (11.4%)	Not reported
GFF MDI 4.6/9.6 μg (PT003)	0 of 67 (0%)	5 of 67 (7.5%)	Not reported
GFF MDI 2.4/9.6 μg (PT003)	1 of 71 (1.4%)	9 of 71 (12.7%)	Not reported
GFF MDI 1.2/9.6 μg (PT003)	2 of 68 (2.9%)	2 of 68 (2.9%)	Not reported
FF MDI 9.6 μg (PT005)	1 of 73 (1.4%)	8 of 73 (11%)	Not reported
Spiriva	0 of 71 (0%)	6 of 71 (8.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PT003, PT001 and PT005 in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 19 sites in United States.

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 11 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 30 Jun 2016). 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 AUC 0-12 on Day 7 (time frame: Day 7). 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 NCT01587079.

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 30 Jun 2016.