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 | January 2021 |
| Source | Pearl Therapeutics, Inc. |
| 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 | Research Site | Abingdon | Virginia |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Anderson | South Carolina |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Dacula | Georgia |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Dothan | Alabama |
| United States | Research Site | Dublin | Ohio |
| United States | Research Site | Easley | South Carolina |
| United States | Research Site | Edina | Minnesota |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Gastonia | North Carolina |
| United States | Research Site | Gold River | California |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Hendersonville | North Carolina |
| United States | Research Site | Indian Land | South Carolina |
| United States | Research Site | Jasper | Alabama |
| United States | Research Site | Johnson City | Tennessee |
| United States | Research Site | Kingwood | Texas |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Longview | Texas |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | Morgantown | West Virginia |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Research Site | Newport News | Virginia |
| United States | Research Site | Norcross | Georgia |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Ormond Beach | Florida |
| United States | Research Site | Pensacola | Florida |
| United States | Research Site | Peoria | Arizona |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Poway | California |
| United States | Research Site | Reno | Nevada |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rincon | Georgia |
| United States | Research Site | Rock Hill | South Carolina |
| United States | Research Site | Rolling Hills Estates | California |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Saint Charles | Missouri |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Seneca | South Carolina |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tamarac | Florida |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Union | South Carolina |
| United States | Research Site | Wilmington | North Carolina |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Winter Park | Florida |
| United States | Research Site | Woodbury | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Pearl Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in BMD of the Lumbar Spine | Percent change from baseline in BMD of the lumbar spine T-Score at Week 52. | at week 52 | |
| Primary | Change From Baseline in the LOCS III (P) Score 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. | at week 52 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT06000696 -
Healthy at Home Pilot
|
||
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
||
| Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
| Completed |
NCT04105075 -
COPD in Obese Patients
|
||
| Recruiting |
NCT05825261 -
Exploring Novel Biomarkers for Emphysema Detection
|
||
| Active, not recruiting |
NCT04075331 -
Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
|
Phase 2/Phase 3 | |
| Terminated |
NCT03640260 -
Respiratory Regulation With Biofeedback in COPD
|
N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|
||
| Withdrawn |
NCT04210050 -
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
|
N/A | |
| Terminated |
NCT03284203 -
Feasibility of At-Home Handheld Spirometry
|
N/A | |
| Recruiting |
NCT06110403 -
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT06040424 -
Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
|
Phase 3 | |
| Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
| Recruiting |
NCT04868357 -
Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program
|
N/A | |
| Completed |
NCT01892566 -
Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
|
N/A | |
| Completed |
NCT04119856 -
Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD
|
N/A | |
| Completed |
NCT04485741 -
Strados System at Center of Excellence
|
||
| Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
| Recruiting |
NCT04860375 -
Multidisciplinary Management of Severe COPD
|
N/A |