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Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the delivery of medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.
ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo ELLIPTA inhaler | Experimental | Subjects will be provided the ELLIPTA inhaler, which is a molded plastic two-sided inhaler that holds two individual blister strips containing either lactose or a blend of lactose and magnesium stearate. Subjects will continue to use regular COPD medications throughout the study as per protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo ELLIPTA inhaler | Drug | The ELLIPTA Dry Powder Inhaler (DPI) is a molded plastic two-sided inhaler that can hold two individual blister strips. Each strip will contain either lactose or a blend of lactose and magnesium stearate. Subjects will receive 1 inhalation once-daily until visit 2. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study. | Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study | Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution. |
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Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply
Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily asthma therapy (as needed [prn] or regularly scheduled).
Has changed maintenance asthma treatment within 4 weeks prior to Screening/Visit 1 or plans to change asthma treatment within 4 weeks of Visit 1.
Any asthma exacerbation, defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral or depot) within 4 weeks of Visit 1. A subject must not have any hospitalisation or emergency department visit due to asthma within 3 months of Visit 1.
Subjects with poorly controlled or who have unstable asthma, in the investigator's judgment that would affect subject's ability to evaluate "ease of use and correct use".
History of life-threatening asthma, defined an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the affect the analysis if the disease/condition exacerbated during the study.
Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36608 | United States | ||
| GSK Investigational Site |
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Participants who were naive to ELLIPTA (trade name of dry powder inhaler owned by GlaxoSmithKline) inhaler use and had an established diagnosis of asthma participated in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo ELLIPTA Inhaler | Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Questionnaire | Other | ELLIPTA Inhaler Ease of Use Questionnaire is a four-point Likert scale. This questionnaire will be filled by investigator (designee) based on responses received from subject. Responses for the questionnaire are Very difficult, Difficult, Easy, Very easy. Subjects will be give either version A or B at Visit 2. |
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| Day 28 |
| The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study | Participants' ability to correctly use the ELLIPTA inhaler was assessed at Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution. | Day 28 |
| Huntington Beach |
| California |
| 92647 |
| United States |
| GSK Investigational Site | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Sunset | Louisiana | 70584 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21236 | 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 | Charlotte | North Carolina | 28277 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Union | South Carolina | 29379 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Waco | Texas | 76712 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo ELLIPTA Inhaler | Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence. |
| 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 (NIH/OMB) | Count of Participants | 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 | The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study. | Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution. | Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2. | Posted | Number | 95% Confidence Interval | Percentage | Day 28 |
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| Secondary | The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study | Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). "Easy to use" was defined as the combination of an "easy" or "very easy" rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution. | mITT Population | Posted | Number | 95% Confidence Interval | Percentage | Day 28 |
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| Secondary | The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study | Participants' ability to correctly use the ELLIPTA inhaler was assessed at Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution. | mITT Population | Posted | Number | 95% Confidence Interval | Percentage | Day 28 |
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Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of Visit 1 until completion of Visit 2 (up to Day 30)
The analysis population used for SAEs and non-serious AEs was Intent-to-Treat population: all participants who were screened and received at least one dose of study treatment (placebo)
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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 | Placebo ELLIPTA Inhaler | Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence. | 0 | 259 | 9 | 259 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA, 18.0 | 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 |
|---|---|
| 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 |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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