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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-4208-1 | Active Comparator | 88 mcg |
|
| TD-4208-2 | Active Comparator | 175 mcg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-4208 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough FEV1 on Day 85 | Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85 | Days 15 to 85 | |
| Summary of Change From Baseline to Peak FEV1 After First Dose | 0-2 hours after First Dose Day 1 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy Associates Research Center (AARC) | Portland | Oregon | 97202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36681255 | Derived | Donohue JF, Ferguson GT, Ohar JA, Lombardi DA, Schneider RF, Johnson K. Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease. Respir Med. 2023 Mar;208:107123. doi: 10.1016/j.rmed.2023.107123. Epub 2023 Jan 18. | |
| 33124005 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | TD-4208-1 | 88 mcg TD-4208 |
| FG001 | TD-4208-2 | 175 mcg TD-4208 |
| FG002 | Placebo | Placebo Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TD-4208-1 | 88 mcg TD-4208 |
| BG001 | TD-4208-2 | 175 mcg TD-4208 |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Trough FEV1 on Day 85 | Intent-to-treat (ITT) analysis set | Posted | Least Squares Mean | Standard Error | mL | Day 85 |
|
From signing of ICF through the final follow-up assessment, Day 85.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TD-4208-1 | 88 mcg TD-4208 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development & Medical Affairs | Theravance Biopharma | 1-855-633-8479 | medinfo@theravance.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C583570 | revefenacin |
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| Drug |
|
| Summary of Rescue Medication Use: Puffs Per Day |
| 1-3 Months |
| Percentage of Albuterol Rescue-free 24-hour Periods | 1-3 Months |
| St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85 | A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units | Baseline to Day 85 |
| Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3. |
| 32393215 | Derived | Donohue JF, Kerwin E, Barnes CN, Moran EJ, Haumann B, Crater GD. Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis. BMC Pulm Med. 2020 May 11;20(1):134. doi: 10.1186/s12890-020-1156-4. |
| Placebo |
Placebo Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85 | Posted | Mean | Standard Error | mL | Days 15 to 85 |
|
|
|
| Secondary | Summary of Change From Baseline to Peak FEV1 After First Dose | Posted | Least Squares Mean | Standard Error | mL | 0-2 hours after First Dose Day 1 |
|
|
|
| Secondary | Summary of Rescue Medication Use: Puffs Per Day | Posted | Least Squares Mean | Standard Error | Puffs per Day | 1-3 Months |
|
|
|
| Secondary | Percentage of Albuterol Rescue-free 24-hour Periods | Posted | Least Squares Mean | Standard Error | Percentage of 24 hr periods | 1-3 Months |
|
|
|
| Secondary | St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85 | A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units | Posted | Count of Participants | Participants | Baseline to Day 85 |
|
|
|
| 212 |
| 10 |
| 212 |
| 51 |
| 212 |
| EG001 | TD-4208-2 | 175 mcg TD-4208 | 0 | 198 | 10 | 198 | 46 | 198 |
| EG002 | Placebo | Placebo Placebo | 1 | 209 | 14 | 209 | 51 | 209 |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Death | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Silent myocardial infarction | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Gastric volvulus | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
The PI may communicate the trial results generated by the PI, but only after the first publication or presentation of the combined study results generated by all participating sites. The Sponsor can then review trial results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |