Phase 3
Completed N=456
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT02536508 ↗Enrolled (actual)
456
Serious AEs
13.6%
Results posted
Feb 2021
Primary outcomePrimary: Percent Change From Baseline in BMD of the Lumbar Spine — -0.093; 0.379; -0.120 Percentage
◆ Published Evidence
Established
27citations · ~7 / year
Predictive modeling of COPD exacerbation rates using baseline risk factors.
Summary
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Linked Publications
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Predictive modeling of COPD exacerbation rates using baseline risk factors.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT02536508) and the linked publication. 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. Informational only — not medical advice.