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

Study identifier:PT003007-00

ClinicalTrials.gov identifier:NCT01854658

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 3

Healthy volunteers

Study drug

GFF MDI (PT003), GP MDI (PT001), FF MDI (PT005), Placebo

Sex

All

Actual Enrollment

1615

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 Jul 2013

Primary Completion Date: 01 Mar 2015

Study Completion Date: 01 Mar 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion criteria

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
Other protocol-defined inclusion/exclusion criteria may apply

No locations available

Arms	Assigned Interventions
Experimental: FF MDI (PT005) FF MDI administered as two puffs BID	Drug: FF MDI (PT005) FF MDI administered as two puffs BID Other Name: formoterol fumarate metered dose inhaler (FF MDI)
Experimental: GP MDI (PT001) GP MDI administered as two puffs BID	Drug: GP MDI (PT001) GP MDI administered as two puffs BID Other Name: glycopyrrolate metered dose inhaler (GP MDI)
Experimental: GFF MDI (PT003) GFF MDI administered as two puffs BID	Drug: GFF MDI (PT003) GFF MDI administered as two puffs BID Other Name: glycopyrrolate/formoterol fumarate metered-dose inhaler Other Name: (GFF MDI)
Placebo Comparator: Placebo MDI Inhaled placebo administered as two puffs BID	-

Documents available

PT003007-02 Protocol Amendment-FINAL-Redacted.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Lori Faria

862-777-8047

[email protected]

Investigators

Principal Investigator

Colin Reisner

Pearl Therapeutics, Inc.