COPD Clinical Trial
Official title:
A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)
| Verified date | January 2021 |
| Source | Pearl Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.
| Status | Completed |
| Enrollment | 8588 |
| Est. completion date | July 26, 2019 |
| Est. primary completion date | July 26, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 80 Years |
| Eligibility | Inclusion Criteria - Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study. - Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), - Current or former smokers with a history of at least 10 pack-years of cigarette smoking. - Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions). - Subjects with history of exacerbations. Please refer to the study protocol for the complete inclusion criteria list. Exclusion Criteria - Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study. - Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception. - Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma. - Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) - Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) - Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia. - Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated. - Subjects who have a history of hypersensitivity to ß2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs. Please refer to the study protocol for the complete inclusion criteria list. |
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| United States | Research Site | Jamaica | New York |
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| United States | Research Site | Spokane | Washington |
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| United States | Research Site | Tacoma | Washington |
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| United States | Research Site | Zachary | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| Pearl Therapeutics, Inc. |
United States, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, New Zealand, Peru, Poland, Russian Federation, Serbia, South Africa, Spain, Sweden, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adjusted Rate of Moderate or Severe Exacerbations | Adjusted Rate of Moderate or Severe Exacerbations | 52-week treatment period | |
| Secondary | Time to First Moderate or Severe COPD Exacerbation | Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event) | 52 Weeks | |
| Secondary | Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks | Change from baseline in average daily rescue Ventolin HFA use over 24 weeks | 24 Weeks | |
| Secondary | Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score | Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24 | at Week 24 | |
| Secondary | Time to Death (All Cause) | Subject Deaths (all cause) | 52 Weeks | |
| Secondary | Rate of Severe COPD Exacerbations | Rate of severe COPD exacerbations | 52 Weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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Healthy at Home Pilot
|
||
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
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N/A | |
| Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
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N/A | |
| Completed |
NCT04105075 -
COPD in Obese Patients
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||
| Recruiting |
NCT05825261 -
Exploring Novel Biomarkers for Emphysema Detection
|
||
| Active, not recruiting |
NCT04075331 -
Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
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Phase 2/Phase 3 | |
| Terminated |
NCT03640260 -
Respiratory Regulation With Biofeedback in COPD
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N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
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| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
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||
| Withdrawn |
NCT04210050 -
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
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N/A | |
| Terminated |
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Feasibility of At-Home Handheld Spirometry
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N/A | |
| Recruiting |
NCT06110403 -
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
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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
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Phase 3 | |
| Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
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||
| Recruiting |
NCT04868357 -
Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program
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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
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N/A | |
| Completed |
NCT04485741 -
Strados System at Center of Excellence
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| Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
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N/A | |
| Recruiting |
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Multidisciplinary Management of Severe COPD
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N/A |