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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revefenacin | Experimental | Active Revefenacin and placebo (in place of Spiriva Handihaler®) |
|
| Spiriva Handihaler® | Active Comparator | Active Spiriva Handihaler® and placebo (in place of Revefenacin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revefenacin | Drug | Revefenacin administered via nebulization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough FEV1 on Day 29 | FEV1 = forced expiratory volume at one second | Baseline and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29 | Baseline and Day 29 | |
| Change From Baseline Trough Inspiratory Capacity (IC) on Day 29 | Baseline and Day 29 | |
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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 |
|---|---|---|---|---|---|---|
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38560416 | Derived | Ohar JA, Mahler DA, Davis GN, Lombardi DA, Moran EJ, Crater GD. Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow. Can Respir J. 2024 Mar 22;2024:8034923. doi: 10.1155/2024/8034923. eCollection 2024. | |
| 32343967 | Derived | Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Revefenacin | Active Revefenacin and placebo (in place of Spiriva Handihaler®) Revefenacin: Revefenacin administered via nebulization. Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®. |
| FG001 | Spiriva Handihaler® | Active Spiriva Handihaler® and placebo (in place of Revefenacin) Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device. Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat (ITT) analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Revefenacin | Active Revefenacin and placebo (in place of Spiriva Handihaler®) Revefenacin: Revefenacin administered via nebulization. Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®. |
| BG001 | Spiriva Handihaler® |
| 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 29 | FEV1 = forced expiratory volume at one second | Intent-to-treat (ITT) analysis set | Posted | Least Squares Mean | Standard Error | mL | Baseline and Day 29 |
|
From signing of ICF through the final follow-up assessment (approximately 1 month).
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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 | Revefenacin | Active Revefenacin and placebo (in place of Spiriva Handihaler®) Revefenacin: Revefenacin administered via nebulization. Placebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®. |
| 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 |
|---|---|---|---|---|---|
| Headache | Nervous system 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2017 | Dec 1, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2017 | Nov 30, 2018 | SAP_000.pdf |
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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 |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Spiriva Handihaler® | Combination Product | Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device. |
|
|
| Placebo for Revefenacin | Drug | Placebo administered as double blind, double dummy via nebulization. |
|
| Placebo for Spiriva Handihaler® | Drug | Placebo administered as double blind, double dummy via Spiriva HandiHaler®. |
|
| Change From Baseline Peak FEV1 on Day 29 |
| Baseline and Day 29 (0-4 hours) |
| Change From Baseline Peak FVC on Day 29 | Baseline and Day 29 (0-4 hours) |
| Summary of Rescue Medication Use: Puffs Per Day | 1 Month |
| 31647854 | Derived | Mahler DA, Ohar JA, Barnes CN, Moran EJ, Pendyala S, Crater GD. Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):321-31. doi: 10.15326/jcopdf.6.4.2019.0137. |
Active Spiriva Handihaler® and placebo (in place of Revefenacin) Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device. Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization. |
| BG002 | 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 | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29 | Posted | Least Squares Mean | Standard Error | mL | Baseline and Day 29 |
|
|
|
| Secondary | Change From Baseline Trough Inspiratory Capacity (IC) on Day 29 | Posted | Least Squares Mean | Standard Error | mL | Baseline and Day 29 |
|
|
|
| Secondary | Change From Baseline Peak FEV1 on Day 29 | Posted | Least Squares Mean | Standard Error | mL | Baseline and Day 29 (0-4 hours) |
|
|
|
| Secondary | Change From Baseline Peak FVC on Day 29 | Posted | Least Squares Mean | Standard Error | mL | Baseline and Day 29 (0-4 hours) |
|
|
|
| Secondary | Summary of Rescue Medication Use: Puffs Per Day | Posted | Least Squares Mean | Standard Error | puffs per day | 1 Month |
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| 5 |
| 103 |
| EG001 | Spiriva Handihaler® | Active Spiriva Handihaler® and placebo (in place of Revefenacin) Spiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device. Placebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization. | 0 | 104 | 1 | 104 | 21 | 104 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Upper respiratory tract infection | 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 |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |