Clinical trial NCT01970878: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 892
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
timeFrame: Baseline and Weeks 2 to 52
Secondary outcomes:
measure: Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
timeFrame: Baseline and Weeks 4 to 52
measure: Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
timeFrame: Baseline and Weeks 2 to 52
measure: Change From Baseline in SGRQ Total Score
timeFrame: Baseline and Weeks 12 to 52
measure: Change From Baseline in Average Daily Rescue Ventolin Use
timeFrame: Baseline through Week 52
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: Pearl Investigative Site
state: Alabama
city: Anniston
country: United States
facility: Pearl Investigative Site
state: Alabama
city: Athens
country: United States
facility: Pearl Investigative Site
state: Alabama
city: Birmingham
country: United States
facility: Pearl Investigative Site
state: Alabama
city: Jasper
country: United States
facility: Pearl Investigative Site
state: Alabama
city: Glendale
country: United States
facility: Pearl Investigative Site
state: Arizona
city: Mesa
country: United States
facility: Pearl Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Pearl Investigative Site
state: Arizona
city: Scottsdale
country: United States
facility: Pearl Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Pearl Investigative Site
state: Arizona
city: Anaheim
country: United States
facility: Pearl Investigative Site
state: California
city: Carlsbad
country: United States
facility: Pearl Investigative Site
state: California
city: Lakewood
country: United States
facility: Pearl Investigative Site
state: California
city: Los Angeles
country: United States
facility: Pearl Investigative Site
state: California
city: Monterey Park
country: United States
facility: Pearl Investigative Site
state: California
city: Pasadena
country: United States
facility: Pearl Investigative Site
state: California
city: Poway
country: United States
facility: Pearl Investigative Site
state: California
city: Sacramento
country: United States
facility: Pearl Investigative Site
state: California
city: San Diego
country: United States
facility: Pearl Investigative Site
state: California
city: Tustin
country: United States
facility: Pearl Investigative Site
state: California
city: Vista
country: United States
facility: Pearl Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Pearl Investigative Site
state: Colorado
city: Denver
country: United States
facility: Pearl Investigative Site
state: Colorado
city: Fort Collins
country: United States
facility: Pearl Investigative Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Pearl Investigative Site
state: Colorado
city: Danbury
country: United States
facility: Pearl Investigative Site
state: Connecticut
city: Waterbury
country: United States
facility: Pearl Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Pearl Investigative Site
state: Florida
city: Miami
country: United States
facility: Pearl Investigative Site
state: Florida
city: Ormond Beach
country: United States
facility: Pearl Investigative Site
state: Florida
city: Panama City
country: United States
facility: Pearl Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Pearl Investigative Site
state: Florida
city: St Petersburg
country: United States
facility: Pearl Investigative Site
state: Florida
city: Tampa
country: United States
facility: Pearl Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Pearl Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Pearl Investigative Site
state: Georgia
city: Austell
country: United States
facility: Pearl Investigative Site
state: Georgia
city: Columbus
country: United States
facility: Pearl Investigative Site
state: Georgia
city: Duluth
country: United States
facility: Pearl Investigative Site
state: Georgia
city: Gainesville
country: United States
facility: Pearl Investigative Site
state: Georgia
city: Couer d'aline
country: United States
facility: Pearl Investigative Site
state: Idaho
city: Champaign
country: United States
facility: Pearl Investigative Site
state: Illinois
city: Evanston
country: United States
facility: Pearl Investigative Site
state: Illinois
city: Peoria
country: United States
facility: Pearl Investigative Site
state: Illinois
city: River Forest
country: United States
facility: Pearl Investigative Site
state: Illinois
city: Avon
country: United States
facility: Pearl Investigative Site
state: Indiana
city: Evansville
country: United States
facility: Pearl Investigative Site
state: Indiana
city: South Bend
country: United States
facility: Pearl Investigative Site
state: Indiana
city: Iowa City
country: United States
facility: Pearl Investigative Site
state: Iowa
city: Olathe
country: United States
facility: Pearl Investigative Site
state: Kansas
city: Topeka
country: United States
facility: Pearl Investigative Site
state: Kansas
city: Louisville
country: United States
facility: Pearl Investigative Site
state: Kentucky
city: Lafayette
country: United States
facility: Pearl Investigative Site
state: Louisiana
city: Sunset
country: United States
facility: Pearl Investigative Site
state: Louisiana
city: Hollywood
country: United States
facility: Pearl Investigative Site
state: Maryland
city: Livonia
country: United States
facility: Pearl Investigative Site
state: Michigan
city: Southfield
country: United States
facility: Pearl Investigative Site
state: Michigan
city: Edina
country: United States
facility: Pearl Investigative Site
state: Minnesota
city: Fridley
country: United States
facility: Pearl Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pearl Investigative Site
state: Minnesota
city: Woodbury
country: United States
facility: Pearl Investigative Site
state: Minnesota
city: Chesterfield
country: United States
facility: Pearl Investigative Site
state: Missouri
city: Springfield
country: United States
facility: Pearl Investigative Site
state: Missouri
city: St Louis
country: United States
facility: Pearl Investigative Site
state: Missouri
city: Bellvue
country: United States
facility: Pearl Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Pearl Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pearl Investigative Site
state: Nevada
city: Albuquerque
country: United States
facility: Pearl Investigative Site
state: New Mexico
city: Corning
country: United States
facility: Pearl Investigative Site
state: New York
city: Burlington
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Huntersville
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Mooresville
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Wilmington
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pearl Investigative Site
state: Ohio
city: Dayton
country: United States
facility: Pearl Investigative Site
state: Ohio
city: Bend
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Brandon
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Medford
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Portland
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Philadelphia
country: United States
facility: Pearl Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pearl Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Easley
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Gaffney
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Murrells Inlet
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Rock Hill
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Rapid City
country: United States
facility: Pearl Investigative Site
state: South Dakota
city: Bristol
country: United States
facility: Pearl Investigative Site
state: Tennessee
city: Johnson City
country: United States
facility: Pearl Investigative Site
state: Tennessee
city: Kingsport
country: United States
facility: Pearl Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Pearl Investigative Site
state: Texas
city: Houston
country: United States
facility: Pearl Investigative Site
state: Texas
city: Huntsville
country: United States
facility: Pearl Investigative Site
state: Texas
city: Longview
country: United States
facility: Pearl Investigative Site
state: Texas
city: New Braunfels
country: United States
facility: Pearl Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Pearl Investigative Site
state: Texas
city: Midvale
country: United States
facility: Pearl Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Pearl Investigative Site
state: Utah
city: South Burlington
country: United States
facility: Pearl Investigative Site
state: Vermont
city: Abingdon
country: United States
facility: Pearl Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Pearl Investigative Site
state: Virginia
city: Spokane
country: United States
facility: Pearl Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Pearl Investigative Site
state: Washington
city: Morgantown
country: United States
facility: Pearl Investigative Site
state: West Virginia
city: West Allis
country: United States
facility: Pearl Investigative Site
state: Wisconsin
city: New Lambton
country: Australia
facility: Pearl Investigative Site
state: New South Wales
city: Westmead
country: Australia
facility: Pearl Investigative Site
state: New South Wales
city: Brisbane
country: Australia
facility: Pearl Investigative Site
state: Queensland
city: Cairns
country: Australia
facility: Pearl Investigative Site
state: Queensland
city: Wooloongabba
country: Australia
facility: Pearl Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Pearl Investigative Site
state: South Australia
city: Heidelberg
country: Australia
facility: Pearl Investigative Site
state: Victoria
city: Nederlands
country: Australia
facility: Pearl Investigative Site
state: Western Australia
city: Perth
country: Australia
facility: Pearl Investigative Site
state: Western Australia
city: Otahuhu
country: New Zealand
facility: Pearl Investigative Site
state: Aukland
city: Caversham
country: New Zealand
facility: Pearl Investigative Site
state: Dunedin
city: Greenlabe
country: New Zealand
facility: Pearl Investigative Site
state: East Aukland
city: Hamilton
country: New Zealand
facility: Pearl Investigative Site
state: Waikato
city: Newtown
country: New Zealand
facility: Pearl Investigative Site
state: Wellington
city: Tauranga
country: New Zealand
facility: Pearl Investigative Site
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Colin Reisner, MD
role: STUDY_CHAIR
References:
citation: 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.