Phase 3 N=456 Randomized Double-blind Treatment

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

COPD

Bottom Line

View on ClinicalTrials.gov: NCT02536508 ↗

Enrolled (actual)

456

Serious AEs

13.6%

Results posted

Feb 2021

Primary outcome: Primary: Percent Change From Baseline in BMD of the Lumbar Spine — -0.093; 0.379; -0.120 Percentage

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BGF MDI 320/14.4/9.6 μg (Drug); GFF MDI 14.4/9.6 μg (Drug); BFF MDI 320/9.6 μg (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Pearl Therapeutics, Inc.
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in BMD of the Lumbar Spine	-0.093; 0.379; -0.120	—
PRIMARY Change From Baseline in the LOCS III (P) Score at Week 52	0.153; .026; 0.022	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02536508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.