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

Phase 3

Completed

Conditions: COPD

Interventions: Drug: GFF MDI 14.4/9.6 μg
Drug: BGF MDI 320/14.4/9.6 μg
Drug: BFF MDI 320/9.6 μg

Registration Number: NCT02536508

Lead Sponsor: Pearl Therapeutics, Inc.

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

Detailed 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 627

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GFF MDI (PT003) 14.4/9.6 μg	GFF MDI 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)
BGF MDI (PT010) 320/14.4/9.6 μg	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)
BFF MDI (PT009) 320/9.6 μg	BFF MDI 320/9.6 μg	Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in BMD of the Lumbar Spine	at week 52	Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
Change From Baseline in the LOCS III (P) Score at Week 52	at week 52	Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.

Secondary Outcome Measures