Chronic Obstructive Pulmonary DiseasePhase 2NCT01349816

PT003 MDI Dose Confirmation Study

A Phase 2 study testing PT003, PT001 and PT005 in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 13 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 demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185 participants
Where: 13 sitesUnited States
Study dates: Jun 2011to Nov 2011
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 (or CT scan) 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

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Pearl Investigative Site
Brooklyn, New York
Pearl Investigative Site
Charlotte, North Carolina
Pearl Investigative Site
Cincinnati, Ohio
Pearl Investigative Site
Clearwater, Florida
Pearl Investigative Site
Colorado Springs, Colorado
Pearl Investigative Site
Medford, Oregon
Pearl Investigative Site
Minneapolis, Minnesota
Pearl Investigative Site
Pensacola, Florida
Pearl Investigative Site
Rancho Mirage, California
Pearl Investigative Site
Spartanburg, South Carolina
Pearl Investigative Site
Stockbridge, Georgia
Pearl Investigative Site
Waterbury, Connecticut
Pearl Investigative Site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: PT003, PT001, PT005
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

Study groups in NCT01349816
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
PT001	Experimental	PT001 MDI Receives: Drug: PT001
PT005	Experimental	PT005 MDI Receives: Drug: PT005

What is being measured

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

FEV1 AUC0-12
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
Measured: Day 7

Secondary outcomes (8)

Peak Change From Baseline in FEV1
Peak change from baseline in FEV1 through 2 hours
Measured: Day 1
Time to Onset of Action
At least 10% improvement in mean FEV1
Measured: Day 1
At Least 12% Improvement in FEV1
Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline
Measured: Day 1
Peak Change in IC
Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline
Measured: Day 1
Morning Pre-dose FEV1
Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)
Measured: Day 7
FEV1 Through 6 Hours
Peak change from baseline in FEV1 through 6 hours
Measured: Day 7
Peak Change From Baseline in IC
Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)
Measured: Day 7
Mean Evening Trough FEV1
Change from baseline in mean evening 12-hour post-dose trough FEV1
Measured: Day 7

Timeline

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

Jun 2011Nov 2011

First posted9 May 2011 (estimated)
Study startJun 2011
Primary completionNov 2011
Study completionNov 2011

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 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: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01349816
Sponsor's protocol ID: PT003004
Status last verified: Apr 2017
First submitted: 5 May 2011
Last updated: 27 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Reisner C, Pearle J, Kerwin EM, Rose ES, Darken P. Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 19;13:1965-1977. doi: 10.2147/COPD.S166455. eCollection 2018.
PubMed 29950826

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

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls
ClinicalTrials.gov ID: NCT01349816
Acronym / sponsor ID: PT003004
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 9 May 2011 (estimated)
Results: Posted 27 Apr 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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

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
PT001	Experimental	Drug: PT001PT001 MDI
PT005	Experimental	Drug: PT005PT005 MDI

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)
PT001PT001 MDI administered as two puffs BID for 7 days	Drug	PT001
PT005PT005 MDI administered as two puffs BID for 7 days	Drug	PT005

Primary outcome

FEV1 AUC0-12
Time frame: Day 7
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).

8 secondary outcomes

Peak Change From Baseline in FEV1
Time frame: Day 1
Time to Onset of Action
Time frame: Day 1
At Least 12% Improvement in FEV1
Time frame: Day 1
Peak Change in IC
Time frame: Day 1
Morning Pre-dose FEV1
Time frame: Day 7
FEV1 Through 6 Hours
Time frame: Day 7
Peak Change From Baseline in IC
Time frame: Day 7
Mean Evening Trough FEV1
Time frame: Day 7

Results and safety

Results posted to the registry on 27 Apr 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
Overall Study	185	155

Primary outcome: FEV1 AUC0-12

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

Measure	GFF MDI 36/7.2 µg n = 49	GFF MDI 36/9.6 µg n = 42	GFF MDI 18/9.6 µg n = 44	GFF MDI 9/9.6 µg n = 50	GP MDI 36 µg n = 49	FF MDI 9.6 µg n = 50
Value	1.467 (1.424 to 1.511)	1.462 (1.418 to 1.508)	1.493 (1.448 to 1.539)	1.499 (1.455 to 1.544)	1.399 (1.358 to 1.441)	1.465 (1.423 to 1.509)

Population analysed: Modified Intent to Treat (MITT) Population is made of participants who completed both treatment periods and had Pre-dose Day 1 data for both and no protocol deviations believed to have a potential impact on efficacy results. Subjects must have had data for the given endpoint to be included.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GFF MDI 36/7.2 µg	1 of 58 (1.7%)	9 of 58 (15.5%)	Not reported
GFF MDI 36/9.6 µg	0 of 56 (0%)	4 of 56 (7.1%)	Not reported
GFF MDI 18/9.6 µg	0 of 57 (0%)	1 of 57 (1.8%)	Not reported
GFF MDI 9/9.6 µg	0 of 57 (0%)	7 of 57 (12.3%)	Not reported
GP MDI 36 µg	2 of 61 (3.3%)	2 of 61 (3.3%)	Not reported
FF MDI 9.6 µg	0 of 61 (0%)	8 of 61 (13.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29950826Reisner C, Pearle J, Kerwin EM, Rose ES, Darken P. Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 19;13:1965-1977. doi: 10.2147/COPD.S166455. eCollection 2018.

Related trials for Chronic Obstructive Pulmonary Disease

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)

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, M.D. study director

Pearl Therapeutics, Inc.

13 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 13 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 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 27 Apr 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 (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 NCT01349816, 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 27 Apr 2017; AzTrials last refreshed its copy on 30 Oct 2026.