Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:4/21/2016
Start Date:November 2013
End Date:March 2015

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A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control

This is a multi-center, randomized, double-blind, parallel group, chronic dosing,
active-controlled, 28-week safety extension study of the two pivotal 24-week safety and
efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the
long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF)
combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate
to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is
included as an active control. To be eligible for this study, a subject must complete
participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).


Key Inclusion Criteria:

- Participant in/completion of previous 24-week PINNACLE Phase III Trial.

- 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/forced vital capacity (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

Key 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) New York Heart Association (NYHA) Class III/IV)

- Clinically significant abnormal 12-lead electrocardiogram (ECG)

- Abnormal liver function tests defined as alanine transaminase (ALT), aspartate
transaminanse (AST), 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
We found this trial at
116
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Rapid City, South Dakota
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Rapid City, SD
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Abingdon, Virginia
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Albuquerque, New Mexico
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Anaheim, California
17
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Andalusia, Alabama
1836
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Anniston, Alabama
1838
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Anniston, AL
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Athens, Alabama
1762
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Athens, AL
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Atlanta, Georgia
1919
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Atlanta, GA
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Austell, Georgia
1904
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Austell, GA
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Austin, Texas
1212
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Austin, TX
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Avon, Indiana
1780
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Avon, IN
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Bellvue, Nebraska
1110
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Bellvue, NE
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712
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Bend, OR
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Birmingham, Alabama
1785
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Birmingham, AL
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Brandon, Oregon
685
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Brandon, OR
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Bristol, Tennessee
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Burlington, North Carolina
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Carlsbad, California
73
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Carlsbad, CA
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Champaign, Illinois
1684
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Charleston, South Carolina
2185
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Charlotte, North Carolina
2101
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Chesterfield, Missouri
1552
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Cincinnati, Ohio
1880
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Clearwater, Florida
2116
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Colorado Springs, Colorado
802
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Columbus, Georgia
1902
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Corning, New York
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Couer d'aline, Idaho
712
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Couer d'aline, ID
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Danbury, Connecticut
2458
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Danbury, CT
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1897
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Dayton, OH
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Denver, Colorado
817
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Duluth, Georgia
1930
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Easley, South Carolina
2007
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Edina, Minnesota
1503
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Evanston, Illinois
1728
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Evansville, Indiana
1714
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Fort Collins, Colorado
839
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Fridley, Minnesota
1512
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Gaffney, South Carolina
2058
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Gainesville, Georgia
1944
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Glendale, Arizona
336
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Greensboro, North Carolina
2151
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Hollywood, Maryland
2309
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Houston, Texas
1357
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Huntersville, North Carolina
2099
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Huntsville, Texas
1327
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Iowa City, Iowa
1529
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Jasper, Alabama
1754
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Johnson City, Tennessee
2008
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Kingsport, Tennessee
1994
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Lafayette, Louisiana
1539
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Lakewood, California
16
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Las Vegas, Nevada
213
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Las Vegas, NV
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Livonia, Michigan
1951
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Longview, Texas
1345
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Los Angeles, California
13
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Louisville, Kentucky
1812
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Medford, Oregon 97504
627
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Medford, Oregon 97504
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Mesa, Arizona
358
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Miami, Florida
2322
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Midvale, Utah
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Minneapolis, Minnesota
1509
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Monterey Park, California
6
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Mooresville, North Carolina
2099
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Morgantown, West Virginia
2122
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Murrells Inlet, South Carolina
2223
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New Braunfels, Texas
1203
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New Lambton, New South Wales
7456
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Olathe, Kansas
1326
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Omaha, Nebraska
1297
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Ormond Beach, Florida
2186
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Panama City, Florida
1904
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Pasadena, California
9
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Pensacola, Florida
1810
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Peoria, Illinois
1618
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Philadelphia, Pennsylvania
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Phoenix, Arizona
343
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Pittsburgh, Pennsylvania
2119
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Portland, Oregon
828
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Poway, California
95
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Raleigh, North Carolina
2218
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Richmond, Virginia
2268
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River Forest, Illinois
1720
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Rock Hill, South Carolina
2094
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Sacramento, California
366
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Salt Lake City, Utah
570
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San Antonio, Texas
1188
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San Diego, California
105
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105
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Scottsdale, Arizona
351
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South Bend, Indiana
1798
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Southfield, Michigan
1958
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Spartanburg, South Carolina
2043
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Spartanburg, South Carolina
2043
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Spokane, Washington
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Springfield, Missouri
1400
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St Louis, Missouri
1573
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St Louis, Missouri
1573
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St Louis, Missouri
1573
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