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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854658
• Other study ID #: PT003007-00
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2013
• Last updated: July 7, 2015
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1618
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Key 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

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 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 ß2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• GFF MDI (PT003)
GFF MDI administered as two puffs BID
• GP MDI (PT001)
GP MDI administered as two puffs BID
• FF MDI (PT005)
FF MDI administered as two puffs BID
• Placebo

Locations

Country	Name	City	State
United States	Pearl Investigative Site	Akron	Ohio
United States	Pearl Investigative Site	Anderson	South Carolina
United States	Pearl Investigative Site	Ann Arbor	Michigan
United States	Pearl Investigative Site	Arlington	Texas
United States	Pearl Investigative Siteq	Baltimore	Maryland
United States	Pearl Investigative Site	Beaumont	Texas
United States	Pearl Investigative Site	Birmingham	Alabama
United States	Pearl Investigative Site	Boerne	Texas
United States	Pearl Investigative Site	Boone	North Carolina
United States	Pearl Investigative Site	Boynton Beach	Florida
United States	Pearl Investigative Site	Bridgeport	West Virginia
United States	Pearl Investigative Site	Buffalo	New York
United States	Pearl Investigative Site	Canton	Ohio
United States	Pearl Investigative Site	Cedar Knolls	New Jersey
United States	Pearl Investigative Site	Centennial	Colorado
United States	Pearl Investigative Site	Charleston	South Carolina
United States	Pearl Investigative Site	Charlotte	North Carolina
United States	Pearl Investigative Site	Cincinnati	Ohio
United States	Pearl Investigative Site	Clearwater	Florida
United States	Pearl Investigative Site	Columbia	Maryland
United States	Pearl Investigative Site	Columbus	Ohio
United States	Pearl Investigative Site	Corsicana	Texas
United States	Pearl Investigative Site	Council Bluffs	Iowa
United States	Pearl Investigative Site	Dallas	Texas
United States	Pearl Investigative Site	Easley	South Carolina
United States	Pearl Investigative Site	Elk Grove	Illinois
United States	Pearl Investigative Site	Evansville	Indiana
United States	Pearl Investigative Site	Florence	Alabama
United States	Pearl Investigative Site	Fort Mill	South Carolina
United States	Pearl Investigative Site	Fort Worth	Texas
United States	Pearl Investigative Site	Franklin	Indiana
United States	Pearl Investigative Site	Fremont	Nebraska
United States	Pearl Investigative Site	Fridley	Minnesota
United States	Pearl Investigative Site	Fullerton	California
United States	Pearl Investigative Site	Gaffney	South Carolina
United States	Pearl Investigative Site	Gold River	California
United States	Pearl Investigative Site	Greenville	South Carolina
United States	Pearl Investigative Site	Haverhill	Massachusetts
United States	Pearl Investigative Site	Hazard	Kentucky
United States	Pearl Investigative Site	Henderson	Nevada
United States	Pearl Investigative Site	Hendersonville	North Carolina
United States	Pearl Investigative Site	Hershey	Pennsylvania
United States	Pearl Investigative Site	Hialeah	Florida
United States	Pearl Investigative Site	Houston	Texas
United States	Pearl Investigative Site	Jacksonville	Florida
United States	Pearl Investigative Site	Jasper	Alabama
United States	Pearl Investigative Site	Kissimmee	Florida
United States	Pearl Investigative Site	Lafayette	Indiana
United States	Pearl Investigative Site	Lake Charles	Louisiana
United States	Pearl Investigative Site	Lawrenceville	Georgia
United States	Pearl Investigative Site	Long Beach	California
United States	Pearl Investigative Site	Los Angeles	California
United States	Pearl Investigative Site	Louisville	Kentucky
United States	Pearl Investigative Site	Marlton	New Jersey
United States	Pearl Investigative Site	Melbourne	Florida
United States	Pearl Investigative Site	Miami	Florida
United States	Pearl Investigative Site	Midlothian	Virginia
United States	Pearl Investigative Site	Minneapolis	Minnesota
United States	Pearl Investigative Site	Mission Hills	California
United States	Pearl Investigative Site	Mobile	Alabama
United States	Pearl Investigative Site	Nashville	Tennessee
United States	Pearl Investigative Site	New Port Richey	Florida
United States	Pearl Investigative Site	New York	New York
United States	Pearl Investigative Site	Newington	New Hampshire
United States	Pearl Investigative Site	Newport Beach	California
United States	Pearl Investigative Site	Newport News	Virginia
United States	Pearl Investigative Site	Norcross	Georgia
United States	Pearl Investigative Site	Normal	Illinois
United States	Pearl Investigative Site	North Dartmouth	Massachusetts
United States	Pearl Investigative Site	North Hollywood	California
United States	Pearl Investigative Site	Northridge	California
United States	Pearl Investigative Site	Oklahoma City	Oklahoma
United States	Pearl Investigative Site	Omaha	Nebraska
United States	Pearl Investigative Site	Orlando	Florida
United States	Pearl Investigative Site	Ormond Beach	Florida
United States	Pearl Investigative Site	Paducah	Kentucky
United States	Pearl Investigative Site	Peoria	Illinois
United States	Pearl Investigative Site	Phoenixville	Pennsylvania
United States	Pearl Investigative Site	Pittsburgh	Pennsylvania
United States	Pearl Investigative Site	Port Orange	Florida
United States	Pearl Investigative Site	Portland	Oregon
United States	Pearl Investigative Site	Raleigh	North Carolina
United States	Pearl Investigative Site	Rancho Mirage	California
United States	Pearl Investigative Site	Rialto	California
United States	Pearl Investigative Site	Richmond	Virginia
United States	Pearl Investigative Site	Ricmond	Virginia
United States	Pearl Investigative Site	Rochester	New York
United States	Pearl Investigative Site	Rochester	Minnesota
United States	Pearl Investigative Site	Rock Hill	South Carolina
United States	Pearl Investigative Site	Rolling Hills Estates	California
United States	Pearl Investigative Site	San Antonio	Texas
United States	Pearl Investigative Site	San Diego	California
United States	Pearl Investigative Site	Sanford	Florida
United States	Pearl Investigative Site	Santa Monica	California
United States	Pearl Investigative Site	Sebring	Florida
United States	Pearl Investigative Site	Seneca	South Carolina
United States	Pearl Investigative Site	Smyrna	Georgia
United States	Pearl Investigative Site	South Bend	Indiana
United States	Pearl Investigative Site	Spartanburg	South Carolina
United States	Pearl Investigative Site	Spokane	Washington
United States	Pearl Investigative Site	St Charles	Missouri
United States	Pearl Investigative Site	St Louis	Missouri
United States	Pearl Investigative Site	St. Louis	Missouri
United States	Pearl Investigative Site	Stockton	California
United States	Pearl Investigative Site	Tacoma	Washington
United States	Pearl Investigative Site	Tamarac	Florida
United States	Pearl Investigative Site	Tomball	Texas
United States	Pearl Investigative Site	Torrance	California
United States	Pearl Investigative Site	Tulsa	Oklahoma
United States	Pearl Investigative Site	Waco	Texas
United States	Pearl Investigative Site	Wildomar	California
United States	Pearl Investigative Site	Willoughby	Ohio
United States	Pearl Investigative Site	Winston-Salem	North Carolina
United States	Pearl Investigative Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in morning pre-dose trough FEV1		24 weeks	No
Secondary	Transition Dyspnea Index (TDI) focal score		24 weeks	No
Secondary	Peak FEV1		24 weeks	No
Secondary	St. George Respiratory Questionnaire (SGRQ) score		24 weeks	No
Secondary	Rescue Ventolin HFA use		24 weeks	No
Secondary	Time to onset of action		Day 1	No