Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

Study identifier:PT003006-00

ClinicalTrials.gov identifier:NCT01854645

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

Study drug

GFF MDI, GP MDI, FF MDI, Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®), Placebo MDI

Sex

All

Actual Enrollment

2103

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 May 2013

Primary Completion Date: 01 Feb 2015

Study Completion Date: 01 Feb 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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.
- Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
- 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) New York Heart Association (NYHA) Class III/IV)
- Clinically significant abnormal 12-lead ECG
- Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (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: GFF MDI Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003)	Drug: GFF MDI GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)
Experimental: GP MDI Glycopyrronium (GP) MDI (PT001)	Drug: GP MDI GP MDI administered as two puffs BID
Experimental: FF MDI Formoterol Fumarate (FF) MDI (PT005)	Drug: FF MDI FF MDI administered as two puffs BID
Active Comparator: Open-label tiotropium bromide inhalation powder Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)	Drug: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Placebo Comparator: Placebo Placebo MDI	Drug: Placebo MDI Inhaled placebo administered as two puffs BID

Documents available

PT003006-02 Protocol and Amendment-FINAL-Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

Lori Faria

862-777-8047

[email protected]

Investigators

Principal Investigator

Colin Reisner

Pearl Therapeutics, Inc.