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

NCT ID: NCT01854658

Last Updated: 2017-03-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1615 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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FF MDI (PT005)

FF MDI administered as two puffs BID

Group Type EXPERIMENTAL

FF MDI (PT005)

Intervention Type DRUG

FF MDI administered as two puffs BID

GP MDI (PT001)

GP MDI administered as two puffs BID

Group Type EXPERIMENTAL

GP MDI (PT001)

Intervention Type DRUG

GP MDI administered as two puffs BID

GFF MDI (PT003)

GFF MDI administered as two puffs BID

Group Type EXPERIMENTAL

GFF MDI (PT003)

Intervention Type DRUG

GFF MDI administered as two puffs BID

Placebo MDI

Inhaled placebo administered as two puffs BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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GFF MDI (PT003)

GFF MDI administered as two puffs BID

Intervention Type DRUG

GP MDI (PT001)

GP MDI administered as two puffs BID

Intervention Type DRUG

FF MDI (PT005)

FF MDI administered as two puffs BID

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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glycopyrrolate/formoterol fumarate metered-dose inhaler (GFF MDI) glycopyrrolate metered dose inhaler (GP MDI) formoterol fumarate metered dose inhaler (FF MDI)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pearl Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colin Reisner, MD

Role: STUDY_CHAIR

Pearl Therapeutics, Inc.

Locations

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Pearl Investigative Site

Birmingham, Alabama, United States

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Pearl Investigative Site

Florence, Alabama, United States

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Pearl Investigative Site

Jasper, Alabama, United States

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Mobile, Alabama, United States

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Fullerton, California, United States

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Gold River, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Mission Hills, California, United States

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Pearl Investigative Site

Newport Beach, California, United States

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North Hollywood, California, United States

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Northridge, California, United States

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Rancho Mirage, California, United States

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Rialto, California, United States

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Rolling Hills Estates, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Stockton, California, United States

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Torrance, California, United States

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Wildomar, California, United States

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Centennial, Colorado, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Port Orange, Florida, United States

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Sanford, Florida, United States

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Sebring, Florida, United States

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Tamarac, Florida, United States

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Winter Park, Florida, United States

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Lawrenceville, Georgia, United States

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Norcross, Georgia, United States

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Smyrna, Georgia, United States

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Elk Grove, Illinois, United States

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Normal, Illinois, United States

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Peoria, Illinois, United States

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Evansville, Indiana, United States

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Franklin, Indiana, United States

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Lafayette, Indiana, United States

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South Bend, Indiana, United States

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Council Bluffs, Iowa, United States

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Hazard, Kentucky, United States

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Louisville, Kentucky, United States

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Paducah, Kentucky, United States

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Lake Charles, Louisiana, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Haverhill, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Fridley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Fremont, Nebraska, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Newington, New Hampshire, United States

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Cedar Knolls, New Jersey, United States

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Marlton, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Boone, North Carolina, United States

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Charlotte, North Carolina, United States

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Hendersonville, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Willoughby, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Hershey, Pennsylvania, United States

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Phoenixville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Easley, South Carolina, United States

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Fort Mill, South Carolina, United States

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Gaffney, South Carolina, United States

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Greenville, South Carolina, United States

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Rock Hill, South Carolina, United States

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Seneca, South Carolina, United States

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Spartanburg, South Carolina, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Beaumont, Texas, United States

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Boerne, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Tomball, Texas, United States

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Waco, Texas, United States

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Midlothian, Virginia, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Ricmond, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Pearl Investigative Site

Bridgeport, West Virginia, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35815359 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32450869 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32021148 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28720336 (View on PubMed)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4151&filename=PT003007-02%20Protocol%20Amendment-FINAL-11Sept14_29June16_Redacted.pdf

PT003007-02 Protocol Amendment-FINAL-Redacted.pdf

Other Identifiers

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PT003007-00

Identifier Type: -

Identifier Source: org_study_id

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