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Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01854658

Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)

A Phase 3 study testing GFF MDI (PT003), GP MDI (PT001) and FF MDI (PT005) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pearl Therapeutics, Inc. at 113 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

This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in… Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
GFF MDI (PT003), GP MDI (PT001) and FF MDI (PT005)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,615 participants
Where
113 sitesUnited States
Study dates
Jul 2013to Mar 2015
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

  • Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
  • 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.
  • Subjects with FEV1/FVC ratio of <0.70 and FEV1 <80% predicted normal and ≥750 mL if FEV1 <30% of predicted normal value.
  • Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Who cannot join

  • Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient 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
  • Current diagnosis of asthma or alpha-1 antitrypsin deficiency
  • Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
  • Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
  • Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
  • Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
Show all 14Show fewer
  • Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
  • Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
  • Congestive heart failure (CHF NYHA Class III/IV)
  • Clinically significant abnormal 12-lead ECG
  • Abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
  • Cancer not in complete remission for at least five years
  • History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

113 sites in 1 country.

113 sites in 1 country

United States113 sites

  • Pearl Investigative Site

    Akron, Ohio

  • Pearl Investigative Site

    Anderson, South Carolina

  • Pearl Investigative Site

    Ann Arbor, Michigan

  • Pearl Investigative Site

    Arlington, Texas

  • Pearl Investigative Siteq

    Baltimore, Maryland

  • Pearl Investigative Site

    Beaumont, Texas

  • Pearl Investigative Site

    Birmingham, Alabama

  • Pearl Investigative Site

    Boerne, Texas

  • Pearl Investigative Site

    Boone, North Carolina

  • Pearl Investigative Site

    Boynton Beach, Florida

  • Pearl Investigative Site

    Bridgeport, West Virginia

  • Pearl Investigative Site

    Buffalo, New York

  • Pearl Investigative Site

    Canton, Ohio

  • Pearl Investigative Site

    Cedar Knolls, New Jersey

  • Pearl Investigative Site

    Centennial, Colorado

  • Pearl Investigative Site

    Charleston, South Carolina

  • Pearl Investigative Site

    Charlotte, North Carolina

  • Pearl Investigative Site

    Cincinnati, Ohio

  • Pearl Investigative Site

    Clearwater, Florida

  • Pearl Investigative Site

    Columbia, Maryland

  • Pearl Investigative Site

    Columbus, Ohio

  • Pearl Investigative Site

    Corsicana, Texas

  • Pearl Investigative Site

    Council Bluffs, Iowa

  • Pearl Investigative Site

    Dallas, Texas

  • Pearl Investigative Site

    Easley, South Carolina

  • Pearl Investigative Site

    Elk Grove, Illinois

  • Pearl Investigative Site

    Evansville, Indiana

  • Pearl Investigative Site

    Florence, Alabama

  • Pearl Investigative Site

    Fort Mill, South Carolina

  • Pearl Investigative Site

    Fort Worth, Texas

  • Pearl Investigative Site

    Franklin, Indiana

  • Pearl Investigative Site

    Fremont, Nebraska

  • Pearl Investigative Site

    Fridley, Minnesota

  • Pearl Investigative Site

    Fullerton, California

  • Pearl Investigative Site

    Gaffney, South Carolina

  • Pearl Investigative Site

    Gold River, California

  • Pearl Investigative Site

    Greenville, South Carolina

  • Pearl Investigative Site

    Haverhill, Massachusetts

  • Pearl Investigative Site

    Hazard, Kentucky

  • Pearl Investigative Site

    Henderson, Nevada

  • Pearl Investigative Site

    Hendersonville, North Carolina

  • Pearl Investigative Site

    Hershey, Pennsylvania

  • Pearl Investigative Site

    Hialeah, Florida

  • Pearl Investigative Site

    Houston, Texas

  • Pearl Investigative Site

    Jacksonville, Florida

  • Pearl Investigative Site

    Jasper, Alabama

  • Pearl Investigative Site

    Kissimmee, Florida

  • Pearl Investigative Site

    Lafayette, Indiana

  • Pearl Investigative Site

    Lake Charles, Louisiana

  • Pearl Investigative Site

    Lawrenceville, Georgia

  • Pearl Investigative Site

    Long Beach, California

  • Pearl Investigative Site

    Los Angeles, California

  • Pearl Investigative Site

    Louisville, Kentucky

  • Pearl Investigative Site

    Marlton, New Jersey

  • Pearl Investigative Site

    Melbourne, Florida, u

  • Pearl Investigative Site

    Miami, Florida

  • Pearl Investigative Site

    Midlothian, Virginia

  • Pearl Investigative Site

    Minneapolis, Minnesota

  • Pearl Investigative Site

    Mission Hills, California

  • Pearl Investigative Site

    Mobile, Alabama

  • Pearl Investigative Site

    Nashville, Tennessee

  • Pearl Investigative Site

    New Port Richey, Florida

  • Pearl Investigative Site

    New York, New York

  • Pearl Investigative Site

    Newington, New Hampshire

  • Pearl Investigative Site

    Newport Beach, California

  • Pearl Investigative Site

    Newport News, Virginia

  • Pearl Investigative Site

    Norcross, Georgia

  • Pearl Investigative Site

    Normal, Illinois

  • Pearl Investigative Site

    North Dartmouth, Massachusetts

  • Pearl Investigative Site

    North Hollywood, California

  • Pearl Investigative Site

    Northridge, California

  • Pearl Investigative Site

    Oklahoma City, Oklahoma

  • Pearl Investigative Site

    Omaha, Nebraska

  • Pearl Investigative Site

    Orlando, Florida

  • Pearl Investigative Site

    Ormond Beach, Florida

  • Pearl Investigative Site

    Paducah, Kentucky

  • Pearl Investigative Site

    Peoria, Illinois

  • Pearl Investigative Site

    Phoenixville, Pennsylvania

  • Pearl Investigative Site

    Pittsburgh, Pennsylvania

  • Pearl Investigative Site

    Port Orange, Florida

  • Pearl Investigative Site

    Portland, Oregon

  • Pearl Investigative Site

    Raleigh, North Carolina

  • Pearl Investigative Site

    Rancho Mirage, California

  • Pearl Investigative Site

    Rialto, California

  • Pearl Investigative Site

    Richmond, Virginia

  • Pearl Investigative Site

    Ricmond, Virginia

  • Pearl Investigative Site

    Rochester, Minnesota

  • Pearl Investigative Site

    Rochester, New York

  • Pearl Investigative Site

    Rock Hill, South Carolina

  • Pearl Investigative Site

    Rolling Hills Estates, California

  • Pearl Investigative Site

    Saint Charles, Missouri

  • Pearl Investigative Site

    San Antonio, Texas

  • Pearl Investigative Site

    San Diego, California

  • Pearl Investigative Site

    Sanford, Florida

  • Pearl Investigative Site

    Santa Monica, California

  • Pearl Investigative Site

    Sebring, Florida

  • Pearl Investigative Site

    Seneca, South Carolina

  • Pearl Investigative Site

    Smyrna, Georgia

  • Pearl Investigative Site

    South Bend, Indiana

  • Pearl Investigative Site

    Spartanburg, South Carolina

  • Pearl Investigative Site

    Spokane, Washington

  • Pearl Investigative Site

    St Louis, Missouri

  • Pearl Investigative Site

    Stockton, California

  • Pearl Investigative Site

    Tacoma, Washington

  • Pearl Investigative Site

    Tamarac, Florida

  • Pearl Investigative Site

    Tomball, Texas

  • Pearl Investigative Site

    Torrance, California

  • Pearl Investigative Site

    Tulsa, Oklahoma

  • Pearl Investigative Site

    Waco, Texas

  • Pearl Investigative Site

    Wildomar, California

  • Pearl Investigative Site

    Willoughby, Ohio

  • Pearl Investigative Site

    Winston-Salem, North Carolina

  • Pearl Investigative Site

    Winter Park, Florida

Other trials in United States

About this study

Official title: A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo

This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.

Being tested
GFF MDI (PT003), GP MDI (PT001), FF MDI (PT005), Placebo
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)Drug

    Also called glycopyrrolate/formoterol fumarate metered-dose inhaler, (GFF MDI)

    GFF MDI administered as two puffs BID

  • GP MDI (PT001)Drug

    Also called glycopyrrolate metered dose inhaler (GP MDI)

    GP MDI administered as two puffs BID

  • FF MDI (PT005)Drug

    Also called formoterol fumarate metered dose inhaler (FF MDI)

    FF MDI administered as two puffs BID

  • PlaceboDrug

Study groups in NCT01854658
Study groupRoleWhat they receive
FF MDI (PT005)ExperimentalFF MDI administered as two puffs BID
Receives: Drug: FF MDI (PT005)
GP MDI (PT001)ExperimentalGP MDI administered as two puffs BID
Receives: Drug: GP MDI (PT001)
GFF MDI (PT003)ExperimentalGFF MDI administered as two puffs BID
Receives: Drug: GFF MDI (PT003)
Placebo MDIPlacebo comparatorInhaled placebo administered as two puffs BID
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in Morning Pre-dose Trough FEV1

    Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.

    Measured: At Week 24

Secondary outcomes (5)

  1. Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks

    Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.

    Measured: Over 24 weeks

  2. Peak FEV1

    Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24

    Measured: At week 24

  3. St. George Respiratory Questionnaire (SGRQ) Score

    Change from baseline in the SGRQ total score at Week 24. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.

    Measured: 24 weeks

  4. Rescue Ventolin HFA Use

    Change from baseline in average daily rescue Ventolin HFA use over 24 weeks

    Measured: 24 weeks

  5. Onset of Action as Assessed by FEV1

    Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant

    Measured: Day 1

Timeline

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

  1. First posted15 May 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,615 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01854658
Sponsor's protocol ID
PT003007-00
Status last verified
Feb 2017
First submitted
13 May 2013
Last updated
28 Mar 2017
Data monitoring committee
Yes

Publications

  • Spata E, Jauhiainen A, Da Silva CA. Impact of season and geography on COPDCompEx: a composite endpoint for COPD trials. Respir Med Res. 2026 Jul 12;90:101305. doi: 10.1016/j.resmer.2026.101305. Online ahead of print.

    PubMed 42551404

  • Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.

    PubMed 35815359

  • Martinez FJ, Lipworth BJ, Rabe KF, Collier DJ, Ferguson GT, Sethi S, Feldman GJ, O'Brien G, Jenkins M, Reisner C. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. Respir Res. 2020 May 25;21(1):128. doi: 10.1186/s12931-020-01388-y.

    PubMed 32450869

  • Martinez FJ, Rabe KF, Lipworth BJ, Arora S, Jenkins M, Martin UJ, Reisner C. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:99-106. doi: 10.2147/COPD.S229794. eCollection 2020.

    PubMed 32021148

  • Martinez FJ, Fabbri LM, Ferguson GT, Orevillo C, Darken P, Martin UJ, Reisner C. Baseline Symptom Score Impact on Benefits of Glycopyrrolate/Formoterol Metered Dose Inhaler in COPD. Chest. 2017 Dec;152(6):1169-1178. doi: 10.1016/j.chest.2017.07.007. Epub 2017 Jul 16.

    PubMed 28720336

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GFF MDI (PT003), GP MDI (PT001) and FF MDI (PT005) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pearl Therapeutics, Inc. at 113 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 5 inclusion and 14 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 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. 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 28 Mar 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?

Change From Baseline in Morning Pre-dose Trough FEV1 (time frame: At Week 24). 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 NCT01854658, which also lists 5 linked publications.

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 28 Mar 2017.

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