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

NCT01854658 | Completed Phase 3 Results DMC

• 1 other identifier: PT003007-00
• Study Type: interventional
• Target: 1,615
• Locations: 1 country
• Sites: 113

Brief 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 subjects with moderate to very severe COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (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.

  At Week 24

Secondary Outcomes (5)

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

  Over 24 weeks

• Peak FEV1

  At week 24

• St. George Respiratory Questionnaire (SGRQ) Score

  24 weeks

• Rescue Ventolin HFA Use

  24 weeks

• Onset of Action as Assessed by FEV1

  Day 1

Study Arms (4)

FF MDI (PT005)

EXPERIMENTAL

FF MDI administered as two puffs BID

Drug: FF MDI (PT005)

GP MDI (PT001)

EXPERIMENTAL

GP MDI administered as two puffs BID

Drug: GP MDI (PT001)

GFF MDI (PT003)

EXPERIMENTAL

GFF MDI administered as two puffs BID

Drug: GFF MDI (PT003)

Placebo MDI

PLACEBO COMPARATOR

Inhaled placebo administered as two puffs BID

Drug: Placebo

Interventions

GFF MDI (PT003) DRUG

GFF MDI administered as two puffs BID

Also known as: glycopyrrolate/formoterol fumarate metered-dose inhaler, (GFF MDI)

GFF MDI (PT003)

GP MDI (PT001) DRUG

GP MDI administered as two puffs BID

Also known as: glycopyrrolate metered dose inhaler (GP MDI)

GP MDI (PT001)

FF MDI (PT005) DRUG

FF MDI administered as two puffs BID

Also known as: formoterol fumarate metered dose inhaler (FF MDI)

FF MDI (PT005)

Placebo DRUG

Placebo MDI

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (113)

Pearl Investigative Site

Birmingham, Alabama, United States

Location

Pearl Investigative Site

Florence, Alabama, United States

Location

Pearl Investigative Site

Jasper, Alabama, United States

Location

Pearl Investigative Site

Mobile, Alabama, United States

Location

Pearl Investigative Site

Fullerton, California, United States

Location

Pearl Investigative Site

Gold River, California, United States

Location

Pearl Investigative Site

Long Beach, California, United States

Location

Pearl Investigative Site

Los Angeles, California, United States

Location

Pearl Investigative Site

Mission Hills, California, United States

Location

Pearl Investigative Site

Newport Beach, California, United States

Location

Pearl Investigative Site

North Hollywood, California, United States

Location

Pearl Investigative Site

Northridge, California, United States

Location

Pearl Investigative Site

Rancho Mirage, California, United States

Location

Pearl Investigative Site

Rialto, California, United States

Location

Pearl Investigative Site

Rolling Hills Estates, California, United States

Location

Pearl Investigative Site

San Diego, California, United States

Location

Pearl Investigative Site

Santa Monica, California, United States

Location

Pearl Investigative Site

Stockton, California, United States

Location

Pearl Investigative Site

Torrance, California, United States

Location

Pearl Investigative Site

Wildomar, California, United States

Location

Pearl Investigative Site

Centennial, Colorado, United States

Location

Pearl Investigative Site

Boynton Beach, Florida, United States

Location

Pearl Investigative Site

Clearwater, Florida, United States

Location

Pearl Investigative Site

Hialeah, Florida, United States

Location

Pearl Investigative Site

Jacksonville, Florida, United States

Location

Pearl Investigative Site

Kissimmee, Florida, United States

Location

Pearl Investigative Site

Melbourne, Florida, u, United States

Location

Pearl Investigative Site

Miami, Florida, United States

Location

Pearl Investigative Site

New Port Richey, Florida, United States

Location

Pearl Investigative Site

Orlando, Florida, United States

Location

Pearl Investigative Site

Ormond Beach, Florida, United States

Location

Pearl Investigative Site

Port Orange, Florida, United States

Location

Pearl Investigative Site

Sanford, Florida, United States

Location

Pearl Investigative Site

Sebring, Florida, United States

Location

Pearl Investigative Site

Tamarac, Florida, United States

Location

Pearl Investigative Site

Winter Park, Florida, United States

Location

Pearl Investigative Site

Lawrenceville, Georgia, United States

Location

Pearl Investigative Site

Norcross, Georgia, United States

Location

Pearl Investigative Site

Smyrna, Georgia, United States

Location

Pearl Investigative Site

Elk Grove, Illinois, United States

Location

Pearl Investigative Site

Normal, Illinois, United States

Location

Pearl Investigative Site

Peoria, Illinois, United States

Location

Pearl Investigative Site

Evansville, Indiana, United States

Location

Pearl Investigative Site

Franklin, Indiana, United States

Location

Pearl Investigative Site

Lafayette, Indiana, United States

Location

Pearl Investigative Site

South Bend, Indiana, United States

Location

Pearl Investigative Site

Council Bluffs, Iowa, United States

Location

Pearl Investigative Site

Hazard, Kentucky, United States

Location

Pearl Investigative Site

Louisville, Kentucky, United States

Location

Pearl Investigative Site

Paducah, Kentucky, United States

Location

Pearl Investigative Site

Lake Charles, Louisiana, United States

Location

Pearl Investigative Siteq

Baltimore, Maryland, United States

Location

Pearl Investigative Site

Columbia, Maryland, United States

Location

Pearl Investigative Site

Haverhill, Massachusetts, United States

Location

Pearl Investigative Site

North Dartmouth, Massachusetts, United States

Location

Pearl Investigative Site

Ann Arbor, Michigan, United States

Location

Pearl Investigative Site

Fridley, Minnesota, United States

Location

Pearl Investigative Site

Minneapolis, Minnesota, United States

Location

Pearl Investigative Site

Rochester, Minnesota, United States

Location

Pearl Investigative Site

Saint Charles, Missouri, United States

Location

Pearl Investigative Site

St Louis, Missouri, United States

Location

Pearl Investigative Site

Fremont, Nebraska, United States

Location

Pearl Investigative Site

Omaha, Nebraska, United States

Location

Pearl Investigative Site

Henderson, Nevada, United States

Location

Pearl Investigative Site

Newington, New Hampshire, United States

Location

Pearl Investigative Site

Cedar Knolls, New Jersey, United States

Location

Pearl Investigative Site

Marlton, New Jersey, United States

Location

Pearl Investigative Site

Buffalo, New York, United States

Location

Pearl Investigative Site

New York, New York, United States

Location

Pearl Investigative Site

Rochester, New York, United States

Location

Pearl Investigative Site

Boone, North Carolina, United States

Location

Pearl Investigative Site

Charlotte, North Carolina, United States

Location

Pearl Investigative Site

Hendersonville, North Carolina, United States

Location

Pearl Investigative Site

Raleigh, North Carolina, United States

Location

Pearl Investigative Site

Winston-Salem, North Carolina, United States

Location

Pearl Investigative Site

Akron, Ohio, United States

Location

Pearl Investigative Site

Canton, Ohio, United States

Location

Pearl Investigative Site

Cincinnati, Ohio, United States

Location

Pearl Investigative Site

Columbus, Ohio, United States

Location

Pearl Investigative Site

Willoughby, Ohio, United States

Location

Pearl Investigative Site

Oklahoma City, Oklahoma, United States

Location

Pearl Investigative Site

Tulsa, Oklahoma, United States

Location

Pearl Investigative Site

Portland, Oregon, United States

Location

Pearl Investigative Site

Hershey, Pennsylvania, United States

Location

Pearl Investigative Site

Phoenixville, Pennsylvania, United States

Location

Pearl Investigative Site

Pittsburgh, Pennsylvania, United States

Location

Pearl Investigative Site

Anderson, South Carolina, United States

Location

Pearl Investigative Site

Charleston, South Carolina, United States

Location

Pearl Investigative Site

Easley, South Carolina, United States

Location

Pearl Investigative Site

Fort Mill, South Carolina, United States

Location

Pearl Investigative Site

Gaffney, South Carolina, United States

Location

Pearl Investigative Site

Greenville, South Carolina, United States

Location

Pearl Investigative Site

Rock Hill, South Carolina, United States

Location

Pearl Investigative Site

Seneca, South Carolina, United States

Location

Pearl Investigative Site

Spartanburg, South Carolina, United States

Location

Pearl Investigative Site

Nashville, Tennessee, United States

Location

Pearl Investigative Site

Arlington, Texas, United States

Location

Pearl Investigative Site

Beaumont, Texas, United States

Location

Pearl Investigative Site

Boerne, Texas, United States

Location

Pearl Investigative Site

Corsicana, Texas, United States

Location

Pearl Investigative Site

Dallas, Texas, United States

Location

Pearl Investigative Site

Fort Worth, Texas, United States

Location

Pearl Investigative Site

Houston, Texas, United States

Location

Pearl Investigative Site

San Antonio, Texas, United States

Location

Pearl Investigative Site

Tomball, Texas, United States

Location

Pearl Investigative Site

Waco, Texas, United States

Location

Pearl Investigative Site

Midlothian, Virginia, United States

Location

Pearl Investigative Site

Newport News, Virginia, United States

Location

Pearl Investigative Site

Richmond, Virginia, United States

Location

Pearl Investigative Site

Ricmond, Virginia, United States

Location

Pearl Investigative Site

Spokane, Washington, United States

Location

Pearl Investigative Site

Tacoma, Washington, United States

Location

Pearl Investigative Site

Bridgeport, West Virginia, United States

Location

Related Publications (4)

• 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.

  PMID: 35815359 DERIVED

• 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.

  PMID: 32450869 DERIVED

• 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.

  PMID: 32021148 DERIVED

• 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.

  PMID: 28720336 DERIVED

Related Links

• PT003007-02 Protocol Amendment-FINAL-Redacted.pdf

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Colin Reisner, MD, FCCP, FAAAAI
• Organization: Pearl Therapeutics, Inc

creisner@pearltherapeutics.com

973-975-0320

Study Officials

• Colin Reisner, MD

  Pearl Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 15, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 28, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-02

Locations

US (113)