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Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD

NCT ID: NCT02343458

Last Updated: 2019-02-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-30

Study Completion Date

2017-08-31

Brief Summary

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A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.

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Detailed Description

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A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GFF MDI (PT003)

Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

Group Type EXPERIMENTAL

GFF MDI (PT003)

Intervention Type DRUG

Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

FF MDI (PT005)

Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

Group Type EXPERIMENTAL

FF MDI (PT005)

Intervention Type DRUG

Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

GP MDI (PT001)

Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

Group Type EXPERIMENTAL

GP MDI (PT001)

Intervention Type DRUG

Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

Placebo MDI

Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)

Group Type PLACEBO_COMPARATOR

Placebo MDI

Intervention Type DRUG

Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)

Interventions

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GFF MDI (PT003)

Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

Intervention Type DRUG

FF MDI (PT005)

Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

Intervention Type DRUG

GP MDI (PT001)

Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

Intervention Type DRUG

Placebo MDI

Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)

Intervention Type DRUG

Other Intervention Names

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Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol Placebo (matching) for GFF MDI, FF MDI, and GP MDI

Eligibility Criteria

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Inclusion Criteria

* Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
* 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.
* Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of \<0.70.
* FEV1 must be \<80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).

Exclusion Criteria

* Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject 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.
* Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
* Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, 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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Andalusia, Alabama, United States

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Birmingham, Alabama, United States

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Foley, Alabama, United States

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Jasper, Alabama, United States

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Anaheim, California, United States

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Boulder, Colorado, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Panama City, Florida, United States

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Pensacola, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Blue Ridge, Georgia, United States

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North Dartmouth, Massachusetts, United States

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Edina, Minnesota, United States

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Fridley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Woodbury, 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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Gastonia, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Dublin, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Easley, 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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Union, South Carolina, United States

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Johnson City, Tennessee, United States

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Abingdon, Virginia, United States

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Changchun, , China

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Changsha, , China

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Chengdu, , China

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Chengdu, , China

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Guangzhou, , China

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Guangzhou, , China

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Guangzhou, , China

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Guiyang, , China

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Haikou, , China

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Hefei, , China

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Heshan, , China

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Hohhot, , China

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Nanchang, , China

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Nanjing, , China

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Nanning, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shengyang, , China

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Shenyang, , China

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Shijiazhuang, , China

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Shijiazhuang, , China

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Suzhou, , China

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Taiyuan, , China

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Tianjin, , China

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Wuxi, , China

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Xiamen, , China

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Xining, , China

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Jindřichův Hradec, , Czechia

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Ostrava-Hrabuvka, , Czechia

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Prague, , Czechia

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Teplice, , Czechia

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Augsburg, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Grosshansdof, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Wiesbaden, , Germany

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Budapest, , Hungary

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Gödöllő, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Siófok, , Hungary

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Szeged, , Hungary

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Ako-shi, , Japan

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Asahikawa-shi, , Japan

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Chūōku, , Japan

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Chūōku, , Japan

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Fukuoka, , Japan

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Hamamatsu, , Japan

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Himeji-shi, , Japan

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Himeji-shi, , Japan

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Hitachi-Naka, , Japan

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Itabashi-ku, , Japan

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Kakogawa-shi, , Japan

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Kamogawa-shi, , Japan

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Kanazawa, , Japan

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Kishiwada-shi, , Japan

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Kobe, , Japan

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Koga-shi, , Japan

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Matsumoto-shi, , Japan

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Matsumoto-shi, , Japan

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Mito, , Japan

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Nagaoka-shi, , Japan

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Nagoya, , Japan

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Naka-gun, , Japan

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Ohota-ku, , Japan

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Ōita, , Japan

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Saiki-shi, , Japan

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Sendai, , Japan

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Sendai, , Japan

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Seto-shi, , Japan

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Shimotsuga-gun, , Japan

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Takamatsu, , Japan

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Toon-shi, , Japan

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Yanagawa-shi, , Japan

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Yokohama, , Japan

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Yokohama, , Japan

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Bialystok, , Poland

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Bialystok, , Poland

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Elblag, , Poland

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Inowrocław, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Piekary Śląskie, , Poland

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Rzeszów, , Poland

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Skierniewice, , Poland

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Szczecin, , Poland

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Tarnów, , Poland

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Torun, , Poland

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Warszawa Targowek, , Poland

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Gatchina, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Pytigorsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Busan, , South Korea

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Daegu, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Wŏnju, , South Korea

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Dundee, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Northwood, , United Kingdom

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Sidcup, , United Kingdom

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Countries

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United States China Czechia Germany Hungary Japan Poland Russia South Korea Taiwan United Kingdom

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)

Chen R, Zhong N, Wang HY, Zhao L, Mei X, Qin Z, Huang J, Assam PN, Maes A, Siddiqui S, Martin UJ, Reisner C. Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2020 Jan 8;15:43-56. doi: 10.2147/COPD.S223638. eCollection 2020.

Reference Type DERIVED
PMID: 32021143 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014%20Statistical%20Analysis%20Plan%2011_01_01%20_Redacted%20updated%2020181003%20PDFA.pdf

Updated cover page

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014-05-%20CLINICAL%20STUDY%20PROTOCOL%20Redacted_updated%2020181003%20PDFA.pdf

Updated Cover page

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014-05-%20CLINICAL%20STUDY%20PROTOCOL%20Redacted%20PDFA.pdf

Updated Cover page

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014%20Statistical%20Analysis%20Plan%20PDFA.pdf

Updated cover page

Other Identifiers

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PT003014

Identifier Type: -

Identifier Source: org_study_id

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