COPD Clinical Trial
Official title:
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
| Verified date | May 2018 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
| Status | Completed |
| Enrollment | 627 |
| Est. completion date | September 12, 2017 |
| Est. primary completion date | September 12, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pearl Investigative Site | Abingdon | Virginia |
| United States | Pearl Investigative Site | Albuquerque | New Mexico |
| United States | Pearl Investigative Site | Andalusia | Alabama |
| United States | Pearl Investigative Site | Anderson | South Carolina |
| United States | Pearl Investigative Site | Birmingham | Alabama |
| United States | Pearl Investigative Site | Boynton Beach | Florida |
| United States | Pearl Investigative Site | Charleston | South Carolina |
| United States | Pearl Investigative Site | Charlotte | North Carolina |
| United States | Pearl Investigative Site | Cincinnati | Ohio |
| United States | Pearl Investigative Site | Clearwater | Florida |
| United States | Pearl Investigative Site | Columbus | Georgia |
| United States | Pearl Investigative Site | Columbus | Ohio |
| United States | Pearl Investigative Site | Cornelius | North Carolina |
| United States | Pearl Investigative Site | Dayton | Ohio |
| United States | Pearl Investigative Site | Dublin | Ohio |
| United States | Pearl Investigative Site | Duluth | Georgia |
| United States | Pearl Investigative Site | Easley | South Carolina |
| United States | Pearl Investigative Site | Edina | Minnesota |
| United States | Pearl Investigative Site | Fullerton | California |
| United States | Pearl Investigative Site | Gastonia | North Carolina |
| United States | Pearl Investigative Site | Gold River | California |
| United States | Pearl Investigative Site | Greensboro | North Carolina |
| United States | Pearl Investigative Site | Greenville | South Carolina |
| United States | Pearl Investigative Site | Henderson | Nevada |
| United States | Pearl Investigative Site | Hendersonville | North Carolina |
| United States | Pearl Investigative Site | Huntersville | North Carolina |
| United States | Pearl Investigative Site | Indian Land | South Carolina |
| United States | Pearl Investigative Site | Jasper | Alabama |
| United States | Pearl Investigative Site | Johnson City | Tennessee |
| United States | Pearl Investigative Site | Kingwood | Texas |
| United States | Pearl Investigative Site | Kissimmee | Florida |
| United States | Pearl Investigative Site | Longview | Texas |
| United States | Pearl Investigative Site | Miami | Florida |
| United States | Pearl Investigative Site | Minneapolis | Minnesota |
| United States | Pearl Investigative Site | Mount Pleasant | South Carolina |
| United States | Pearl Investigative Site | Newport News | Virginia |
| United States | Pearl Investigative Site | Oklahoma City | Oklahoma |
| United States | Pearl Investigative Site | Ormond Beach | Florida |
| United States | Pearl Investigative Site | Pensacola | Florida |
| United States | Pearl Investigative Site | Phoenix | Arizona |
| United States | Pearl Investigative Site | Poway | California |
| United States | Pearl Investigative Site | Rapid City | South Dakota |
| United States | Pearl Investigative Site | Reno | Nevada |
| United States | Pearl Investigative Site | Richmond | Virginia |
| United States | Pearl Investigative Site | Richmond | Virginia |
| United States | Pearl Investigative Site | Rincon | Georgia |
| United States | Pearl Investigative Site | Rock Hill | South Carolina |
| United States | Pearl Investigative Site | Rolling Hills Estates | California |
| United States | Pearl Investigative Site | Sacramento | California |
| United States | Pearl Investigative Site | Saint Charles | Missouri |
| United States | Pearl Investigative Site | Saint Louis | Missouri |
| United States | Pearl Investigative Site | San Antonio | Texas |
| United States | Pearl Investigative Site | Seneca | South Carolina |
| United States | Pearl Investigative Site | Spartanburg | South Carolina |
| United States | Pearl Investigative Site | Tacoma | Washington |
| United States | Pearl Investigative Site | Tampa | Florida |
| United States | Pearl Investigative Site | Tucson | Arizona |
| United States | Pearl Investigative Site | Union | South Carolina |
| United States | Pearl Investigative Site | Wilmington | North Carolina |
| United States | Pearl Investigative Site | Winter Park | Florida |
| United States | Pearl Investigative Site | Woodbury | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent change from baseline Bone Mineral Density (BMD) of the lumbar spine measured using DEXA scans of L2-L4 at Week 52 | 52 weeks | ||
| Primary | Change from Baseline in the Lens Opacities Classification System III (LOC III) P scale (P) Score at Week 52 | 52 weeks |
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