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This is a multicenter, stratified, and randomized, open-label, placebo study in subjects with asthma to compare inhalers, ELLIPTA a new dry powder inhaler (DPI) and metered dose inhalers (MDI). This study is conducted to evaluate subject's preference of several inhaler-specific attributes individually between an existing MDI and the ELLIPTA a dry powder inhaler. Subjects who have not used the ELLIPTA inhaler in the past 6 months and their asthma must be controlled on their current therapy were enrolled. Subjects meeting the eligibility criteria will be stratified according to their current inhaler use (stable for the past 3 months): 1.) Currently using a DPI as an inhaled asthma controller therapy OR 2.) Currently using an MDI as an inhaled asthma controller therapy (No fluticasone MDI use in the last 3 months) OR 3.) Currently using no inhaled asthma controller therapy (this includes patients using a LTM and/or SABA only). Once stratified, eligible subjects were randomized (1:1) to one of two sequences for using the inhaler: ELLIPTA inhaler once daily in Period 1 followed by MDI twice daily in Period 2 or MDI twice daily in Period 1 followed by ELLIPTA inhaler once daily in Period 2 for for 5-9 days each. In addition, subjects will be randomly assigned (1:1 allocation) to receive one of two sets of questions: Version 1 presents response options in the order of ELLIPTA inhaler, MDI, No preference; Version 2 presents response options in the order of MDI, ELLIPTA inhaler, No preference. At the end of the second trial period, subjects answered questions which assessed their preference of inhaler attributes. ELLIPTA is a registered trademark of the GSK group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Subjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the MDI inhaler twice daily for 5 to 9 days during the second period. |
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| Group 2 | Subjects will use the MDI 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 inhaler | Device | ELLIPTA inhaler, placebo DPIwith 30 doses (2 strips with 30 blisters per strip containing lactose in strip first strip and Lactose blended with magnesium stearate in second strip) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with the indicated inhaler preference based on the number of steps needed to use the inhaler | The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on the number of steps needed to use the inhaler was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall. | Up to Day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with the indicated inhaler preference based on how easy it is to tell how many doses you have left | The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on how easy it is to tell how many doses you have left was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall. |
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Inclusion Criteria:
Exclusion Criteria
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Diagnosed and treated asthma patients aged 18 years or older
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Huntington Beach | California | 92647 | United States | ||
| GSK Investigational Site |
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| Placebo Inhalation Aerosol (MDI) | Device | Placebo inhaler MDI will be supplied containing aerosol propellant |
|
| Up to Day 18 |
| Number of participants with the indicated inhaler preference based on the comfort of the mouthpiece | The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for MDI inhaler, and no preference) based on the comfort of the mouthpiece was summarized by prior inhaler use, by study inhaler use sequence, by preference question version and overall. | Up to Day 18 |
| Newport Beach |
| California |
| 92663 |
| United States |
| GSK Investigational Site | Vista | California | 92083 | United States |
| GSK Investigational Site | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21236 | United States |
| GSK Investigational Site | Bethesda | Maryland | 20814 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Austin | Texas | 78750 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D036501 | Metered Dose Inhalers |
| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |
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