Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Pearl Therapeutics

Status and phase: Completed; Phase 3

Conditions: COPD

Treatments: Drug: BGF MDI 320/14.4/9.6 μg; Drug: BFF MDI 320/9.6 μg; Drug: GFF MDI 14.4/9.6 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02536508

PT010008

Details and patient eligibility

About

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Full description

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Enrollment: 627 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)

Exclusion criteria

Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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627 participants in 3 patient groups

BGF MDI (PT010) 320/14.4/9.6 μg

Experimental group

Description:

Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)

Treatment:

Drug: BGF MDI 320/14.4/9.6 μg

GFF MDI (PT003) 14.4/9.6 μg

Experimental group

Description:

Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)

Treatment:

Drug: GFF MDI 14.4/9.6 μg

BFF MDI (PT009) 320/9.6 μg

Experimental group

Description:

Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)

Treatment:

Drug: BFF MDI 320/9.6 μg