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The decision to end the study was based on a change in GSK strategy. No subjects were enrolled into the study.
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The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA single inhaler triple therapy (SITT) (fluticasone furoate/umeclidinium bromide/vilanterol [FF/UMEC/VI]) relative to non-ELLIPTA multiple inhaler triple therapies (MITT) of inhaled corticosteroids/long-acting beta2-adrenergic receptor agonists/muscarinic receptor antagonists (ICS/LABA/LAMA) within a routine clinical practice setting. This is a non-randomized, interventional and self-controlled cohort study conducted to collect data in routine practice. This study will have two periods where in retrospective data will be collected in pre-switch period and prospective data will be collected in post-switch periods. Subjects will be switched from non-ELLIPTA MITT to TRELEGY ELLIPTA. The pre-switch period is of 52 weeks and post-switch period will be of 52 weeks. Additionally subjects will receive safety follow-up call at 26 weeks and 52 weeks for safety monitoring. Approximately 1300 subjects will be enrolled for this study. TRELEGY ELLIPTA is a registered trademark of the GlaxoSmithKline (GSK) group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who inhaled non-ELLIPTA MITT | Experimental | Subjects with moderate or severe exacerbation in the past year and history of use of inhaled non-ELLIPTA MITT of ICS/LABA/LAMA within a routine clinical practice setting in the 52-week retrospective pre-switch period. |
|
| Subjects receiving TRELEGY ELLIPTA SITT | Experimental | Subjects will receive FF/UMEC/VI (100 microgram [mcg]/62.5 mcg/25 mcg), inhalation powder, once daily, in a single device (TRELEGY ELLIPTA) in the 52-week prospective post-switch period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists | Drug | A fixed dose of combination ICS/LABA plus LAMA once-daily was administered to COPD subjects using two separate non-ELLIPTA devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of moderate, severe COPD exacerbations | Moderate and severe COPD exacerbations will be defined using an algorithm agreed upon by GlaxoSmithKline and the health plans that identifies these events from health plan medical claims data. Moderate exacerbation is any physician office visit, urgent care visit or emergency room visit for COPD where any oral corticosteroids or antibiotics are prescribed during visit. Severe exacerbations are any COPD related inpatient visit. Exacerbations will be determined in the same fashion in the retrospective pre-switch period and the prospective post switch period. | 104 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Waterbury | Connecticut | 06708 | United States | ||
| GSK Investigational Site |
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This is a retrospective pre-switch and prospective post-switch study design. Subjects will be on their usual care for the retrospective pre-switch period of the study, then they are enrolled into the study and switched onto Trelegy or FF/UMEC/VI for the prospective period.
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| Fluticasone furoate/umeclidinium/vilanterol | Drug | The first strip will contain FF at a dose strength of 100 mcg will be blended with lactose. The second strip will be contain UMEC and VI at a dose strength of 25 mcg and 62.5 mcg blended with lactose and magnesium stearate with respectively. |
|
| Charlotte |
| North Carolina |
| 28207 |
| United States |
| GSK Investigational Site | Layton | Utah | 84041 | United States |
| 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 |
|---|---|
| C523187 | fluticasone furoate |
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