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

Pearl Therapeutics

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: GP MDI (PT001); Drug: FF MDI (PT005); Drug: GFF MDI (PT003)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01854658

PT003007-00

Details and patient eligibility

About

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.

Enrollment: 1,615 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,615 participants in 4 patient groups, including a placebo group

FF MDI (PT005)

Experimental group

Description:

FF MDI administered as two puffs BID

Treatment:

Drug: FF MDI (PT005)

GP MDI (PT001)

Experimental group

Description:

GP MDI administered as two puffs BID

Treatment:

Drug: GP MDI (PT001)

GFF MDI (PT003)

Experimental group

Description:

GFF MDI administered as two puffs BID

Treatment:

Drug: GFF MDI (PT003)

Placebo MDI

Placebo Comparator group

Description:

Inhaled placebo administered as two puffs BID

Treatment:

Drug: Placebo