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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-4208 44 mcg twice daily | Experimental | TD-4208 inhalation solution 44 mcg twice daily for 7 days |
|
| Placebo | Placebo Comparator | Placebo inhalation solution twice daily for 7 days |
|
| TD-4208 175 mcg once daily | Experimental | TD-4208 inhalation solution 175 mcg once daily, placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-4208 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second) | Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline. | Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma, US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Health Research | Charlotte | North Carolina | 28207 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then 44mcg, Then 175mcg | Placebo twice daily for 7 days then 44mcg twice daily for 7 days then 175mcg once daily for 7 days |
| FG001 | Placebo First, Then 175mcg, Then 44mcg | Placebo twice daily for 7 days then 175mcg once daily for 7 days then 44mcg twice daily for 7 days |
| FG002 | 44mcg First, Then 175mcg, Then Placebo | 44mcg twice daily for 7 days then 175mcg once daily for 7 days then placebo twice daily for 7 days |
| FG003 | 44mcg First, Then Placebo, Then 175mcg | 44mcg twice daily for 7 days then placebo twice daily for 7 days then 175mcg once daily for 7 days |
| FG004 | 175mcg First, Then 44mcg, Then Placebo | 175mcg once daily for 7 days then 44mcg twice daily for 7 days then placebo twice daily for 7 days |
| FG005 | 175mcg First, Then Placebo, Then 44mcg | 175mcg once daily for 7 days then placebo twice daily for 7 days then 44mcg twice daily for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All groups were randomized to receive placebo, TD-4208 44mcg twice daily, and TD-4208 175 mcg once daily |
| 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 | Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second) | Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline. | Posted | Least Squares Mean | Standard Error | mL | Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose |
|
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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 | Placebo | Placebo inhalation solution twice daily for 7 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Insufficiency | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Pressure Increased | Vascular disorders |
The study was designed to evaluate whether a lower dose (44) BID would achieve a greater response than a higher dose (175) QD.
| 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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| Placebo |
| Drug |
|
| Adverse Event |
|
| Death |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
TD-4208 inhalation solution 175 mcg once daily, placebo once daily TD-4208 Placebo |
|
|
| 0 |
| 64 |
| 23 |
| 64 |
| EG001 | TD-4208 44mcg Twice Daily | TD-4208 inhalation solution 44 mcg twice daily for 7 days | 0 | 64 | 24 | 64 |
| EG002 | TD-4208 175mcg Once Daily | TD-4208 inhalation solution 175 mcg once daily | 1 | 64 | 14 | 64 |
| Breath sounds abnormal | Respiratory, thoracic and mediastinal disorders |
|
| Chest Discomfort | Respiratory, thoracic and mediastinal disorders |
|
| COPD | Respiratory, thoracic and mediastinal disorders |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders |
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| Dizziness | Nervous system disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
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| Ear Infection | Infections and infestations |
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| Eye Swelling | Injury, poisoning and procedural complications |
|
| Gingival pain | Gastrointestinal disorders |
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| Oedema | General disorders |
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| Headache | Nervous system disorders |
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| Hypotension | Vascular disorders |
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| Inguinal hernia | Gastrointestinal disorders |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
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| Neck Pain | Musculoskeletal and connective tissue disorders |
|
| Oedema | General disorders |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Tremor | Nervous system disorders |
|
| Urinary tract infection | Infections and infestations |
|
| Vomiting | Gastrointestinal disorders |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders |
|
| Abdominal pain lower | Gastrointestinal disorders |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Coronary artery insufficiency | Vascular disorders |
|
| Eye contusion | Injury, poisoning and procedural complications |
|
| Foot fracture | Injury, poisoning and procedural complications |
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| Furuncle | Infections and infestations |
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| Haemoglobin decreased | Investigations |
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| Hypertension | Vascular disorders |
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| Laceration | Injury, poisoning and procedural complications |
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| Oedema peripheral | General disorders |
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| Oral candidiasis | Infections and infestations |
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| Procedural pain | Injury, poisoning and procedural complications |
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| Rales | Respiratory, thoracic and mediastinal disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Sputum increased | Respiratory, thoracic and mediastinal disorders |
|
| Upper respiratory tract infection | Infections and infestations |
|
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 |