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Subjects who have not used the ELLIPTAâ„¢ inhaler nor the DISKUSâ„¢ inhaler in the past 6 months will be screened to participate in the study. Subjects will have an equal chance of being in any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the DISKUS inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The other group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period (twice daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5 to9 days). At the end of the second period, subjects will complete the study by answering 7 questions to assess their preference of device attributes and dosing regimens between the two inhalers.
The null hypothesis for device preference for a specific attribute is that 50% subjects express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA is unity.
The null hypothesis for dosing regimen preference is that 50% subjects express a preference of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice daily dosing or have no preference).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELLIPTA Period 1 and DISKUS Period 2 Arm | Experimental | Subjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the DISKUS inhaler twice daily for 5 to 9 days during the second period. |
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| DISKUS Period 1 and ELLIPTA Period 2 Arm | Experimental | Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELLIPTA | Device | Novel dry powder inhaler (placebo) with 30 doses (2 strips with 30 blisters per strip) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter | The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence. | up to Study Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication | The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the number of steps needed to take the COPD medication was summarized by study inhaler use sequence. | up to Study Day 26 |
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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 | Jasper | Alabama | 35501 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26516724 | Derived | Yun Kirby S, Zhu CQ, Kerwin EM, Stanford RH, Georges G. A Preference Study of Two Placebo Dry Powder Inhalers in Adults with COPD: ELLIPTA(R) Dry Powder Inhaler (DPI) versus DISKUS(R) DPI. COPD. 2016;13(2):167-75. doi: 10.3109/15412555.2015.1057274. Epub 2015 Oct 30. |
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Eligible participants were randomized (1:1) to one of the two sequences of using the two placebo dry powder inhalers (ELLIPTA once a day then DISKUS twice a day or vise versa), each one taken separately for approximately 1 week. The first inhaler in the sequence was dispensed at Visit 1 and the second at Visit 2.
A total of 314 participants were screened; 287 participants were randomized, and 283 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | DISKUS BID in Period 1; ELLIPTA QD in Period 2 | Participants who were on their current chronic obstructive pulmonary disease (COPD) medication(s) were randomized to receive DISKUS twice a day (BID) for 5-9 days in Period 1 and ELLIPTA once a day (QD) for 5-9 days in Period 2. There was no washout period between the two periods. Neither dry powder inhaler (DPI) contained any active treatment; placebo was administered in both DPIs. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (5-9 Days) |
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| DISKUS | Device | Multidose dry powder inhaler (placebo) containing a foil strip worth 60 blisters (1 strip with 60 blisters per strip) |
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| Number of Participants With the Indicated Device Preference Based on the Size of the Device | The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the device was summarized by study inhaler use sequence. | up to Study Day 26 |
| Riverside |
| California |
| 92506 |
| United States |
| GSK Investigational Site | Clearwater | Florida | 33765-2616 | United States |
| GSK Investigational Site | Leesburg | Florida | 34748 | United States |
| GSK Investigational Site | Orlando | Florida | 32825 | United States |
| GSK Investigational Site | Lafayette | Louisiana | 70503 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | United States |
| GSK Investigational Site | Huntersville | North Carolina | 28078 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406-7108 | United States |
| GSK Investigational Site | Easley | South Carolina | 29640 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29615 | United States |
| GSK Investigational Site | Seneca | South Carolina | 29678 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Richmond | Virginia | 23225 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| FG001 | ELLIPTA QD in Period 1; DISKUS BID in Period 2 | Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 (5-9 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | DISKUS BID in Period 1 or 2; ELLIPTA QD in Period 1 or 2 | Participants who were on their current COPD medication(s) were randomized to receive one of the following two sequences of DPIs containing placebo: (1) DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2; (2) ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter | The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence. | Per Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (comprised of all participants who had been randomized and received one dose of at least one study inhaler) who completed at least one question from the seven preference questions | Posted | Number | participants | up to Study Day 26 |
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| Secondary | Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication | The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the number of steps needed to take the COPD medication was summarized by study inhaler use sequence. | PP Population | Posted | Number | Participants | up to Study Day 26 |
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| Secondary | Number of Participants With the Indicated Device Preference Based on the Size of the Device | The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the device was summarized by study inhaler use sequence. | PP Population. Only those participants responding to the question regarding the specified attribute were analyzed. | Posted | Number | Participants | up to Study Day 26 |
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On-treatment serious adverse events (SAEs) and non-serious AEs collected from the start of placebo until Visit 3 (end of study; up to Study Day 26) are reported.
SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized and received one dose of at least one study inhaler.
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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 | ELLIPTA QD in Period 1 or 2 | Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in either Period 1 or Period 2. There was no washout period between the two periods. The DPI did not contain any active treatment; placebo was administered in the DPI. | 3 | 287 | 21 | 287 | ||
| EG001 | DISKUS BID in Period 1 or 2 | Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period. | 0 | 285 | 14 | 285 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
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| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| VIIth nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Sphincter of oddi dysfunction | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Angiopathy | Vascular disorders | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| 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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