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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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The primary objective of the study was to characterize the safety and tolerability of once-daily revefenacin inhalation solution when dosed sequentially with twice-daily formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over 21 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Revefenacin + Formoterol (Sequential) | Experimental | Days 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
|
| Period 2: Revefenacin + Formoterol (Combo Solution) | Experimental | Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
|
| Period 1: Placebo + Formoterol (Sequential) | Placebo Comparator | Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
|
| Period 2: Placebo + Formoterol (Combo Solution) | Placebo Comparator | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revefenacin | Drug | Revefenacin is administered via a nebulizer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event | An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug. | Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
| Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event | A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes:
A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug. | Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
| Number of Participants With Clinically Relevant Changes in Vital Sign Measurements | Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure. | Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
| Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements |
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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 |
|---|---|---|---|---|---|---|
| Theravance Biopharma Investigational Site | Miami | Florida | 33155 | United States | ||
| Theravance Biopharma Investigational Site |
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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Participants were randomized 1:1 to one of two treatment groups and received treatment twice-daily for the two 21-day treatment periods. The participants in Arms 1 and 2 are the same (minus attrition), and the participants in Arms 3 and 4 are the same (minus attrition).
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| ID | Title | Description |
|---|---|---|
| FG000 | Revefenacin + Formoterol | Includes participants from Arm 1 (Day 1-21) and Arm 2 (Day 22-42). |
| FG001 | Placebo + Formoterol | Includes participants from Arm 3 (Day 1-21) and Arm 4 (Day 22-42). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2018 | Nov 27, 2019 |
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This is a randomized, double-blind, placebo-controlled, parallel-group study. Each participant will receive treatment daily for a total of 42 days. One group will receive placebo and formoterol and one group will receive revefenacin and formoterol.
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|
| Placebo | Drug | Placebo version of Revefenacin is administered via a nebulizer. |
|
| Formoterol | Drug | Administered sequentially in both revefenacin and placebo arms using a nebulizer. |
|
Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum. |
| Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
| Number of Participants With Clinically Relevant Changes in Electrocardiogram Results | Clinically relevant changes identified based on change from baseline. | Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
| Orlando |
| Florida |
| 32825 |
| United States |
| Theravance Biopharma Investigational Site | Sarasota | Florida | 34239 | United States |
| Theravance Biopharma Investigational Site | Tampa | Florida | 33603 | United States |
| Theravance Biopharma Investigational Site | Saint Charles | Missouri | 63301 | United States |
| Theravance Biopharma Investigational Site | Monroe | North Carolina | 28112 | United States |
| Theravance Biopharma Investigational Site | Columbus | Ohio | 43213 | United States |
| Theravance Biopharma Investigational Site | Medford | Oregon | 97504 | United States |
| Theravance Biopharma Investigational Site | Erie | Pennsylvania | 16508 | United States |
| Theravance Biopharma Investigational Site | Gaffney | South Carolina | 29341 | United States |
| Theravance Biopharma Investigational Site | Greenville | South Carolina | 29615 | United States |
| Theravance Biopharma Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| Randomized and Treated With Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
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122 participants were enrolled in this study and received at least one dose of study drug. The disposition data is shown for the two different treatment types.
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| ID | Title | Description |
|---|---|---|
| BG000 | Revefenacin + Formoterol | Includes participants from Arm 1 (Day 1-21) and Arm 2 (Day 22-42). |
| BG001 | Placebo + Formoterol | Includes participants from Arm 3 (Day 1-21) and Arm 4 (Day 22-42). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event | An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug. | The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2. | Posted | Count of Participants | Participants | Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event | A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes:
A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug. | The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2. | Posted | Count of Participants | Participants | Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Relevant Changes in Vital Sign Measurements | Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure. | The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2. | Posted | Count of Participants | Participants | Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements | Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum. | The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2. | Posted | Count of Participants | Participants | Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Relevant Changes in Electrocardiogram Results | Clinically relevant changes identified based on change from baseline. | The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2. | Posted | Count of Participants | Participants | Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days) |
|
Period 1: Day 1 to Day 21; Period 2: Day 22 to 42 (+7 days follow-up)
An adverse event was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment.
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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 | Period 1: Revefenacin + Formoterol (Sequential) | Days 1 to 21: Revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening. | 0 | 59 | 0 | 59 | 3 | 63 |
| EG001 | Period 2: Revefenacin + Formoterol (Combo Solution) | Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening. | 0 | 55 | 0 | 55 | 5 | 62 |
| EG002 | Period 1: Placebo + Formoterol (Sequential) | Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening. | 0 | 63 | 0 | 63 | 7 | 59 |
| EG003 | Period 2: Placebo + Formoterol (Combo Solution) | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening. | 0 | 62 | 0 | 62 | 6 | 55 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Sputum purulent | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA Version 18.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 18.1 | Non-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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development & Medical Affairs | Theravance Biopharma | 1-855-633-8479 | medinfo@theravance.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2018 | Nov 27, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C583570 | revefenacin |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Period 2: Revefenacin + Formoterol (Combo Solution) | Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening. |
| OG002 | Period 1: Placebo + Formoterol (Sequential) | Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening. |
| OG003 | Period 2: Placebo + Formoterol (Combo Solution) | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening. |
|
|
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening. |
| OG003 | Period 2: Placebo + Formoterol (Combo Solution) | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening. |
|
|
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening. |
| OG003 | Period 2: Placebo + Formoterol (Combo Solution) | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening. |
|
|
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered via nebulizer in the morning. Formoterol will be administered again in the evening.
| OG003 | Period 2: Placebo + Formoterol (Combo Solution) | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution via a single nebulization. Formoterol will be administered again in the evening. |
|
|