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Asthma is a chronic inflammatory disease of airways and lungs that results in hyper-reactivity and clinically relevant episodes of wheezing. This study has been designed to assess the correct use and ease of use of the ELLIPTA® DPI in pediatric subjects with asthma. ELLIPTA DPI is easy to use, requires few steps, is consistent in dosing and eliminates the hand-breath co-ordination required for metered dose inhalers (MDIs). Subjects will be stratified by age into two strata: Stratum 1: subjects in the age group of 5 to 7 years and Stratum 2: Subjects in the age group of 8 to 11 years. All subjects will be trained by Health care professionals (HCP) for the correct use of ELLIPTA DPI. Subjects will be given three chances to attempt correct use of ELLIPTA DPI; subsequently, if the subject is not successful, the parent/guardian will be able to help instruct the subject on the correct use of the ELLIPTA DPI, for two more attempts. The subjects who will be enrolled in the study will take placebo ELLIPTA DPI once daily. After 28 days subjects will be randomized in 1:1 to receive a questionnaire (Version A and B). After completion of the questionnaire on ELLIPTA DPI ease of use, subject's ability to use ELLIPTA DPI correctly will be re-assessed. Approximately 219 subjects will be screened to participate in the study. The study will be conducted for 28 days. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects using placebo ELLIPTA DPI | Experimental | Subjects in stratum 1 and stratum 2 will be of age group from 5 to 7 years and 8 to 11 years respectively. Subjects will take placebo ELLIPTA DPI once daily. During Visit 2 (Day 28) subjects will be randomized to receive questionnaire on ELLIPTA DPI usage either version A or B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo DPI | Drug | Subjects will receive placebo via oral inhalation route using ELLIPTA once daily. Placebo DPI will be available in two strips of 30 blisters per strip. First strip will contain lactose monohydrate and second strip will have lactose monohydrate blended with magnesium stearate. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 (Day 28) | Participants were trained in the correct use of ELLIPTA DPI by a healthcare professional (HCP) on Day 1 (Visit 1) following which eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on ease of use of ELLIPTA DPI. Participants and their parents/guardian were required to complete the questionnaire, following which participants were assessed for their ability to demonstrate correct use of ELLIPTA DPI (1 attempt with no training or instruction and then 1 attempt after instruction from parent/guardian). Percentage of participants who demonstrated correct use of ELLIPTA was calculated as "number of participants who demonstrated correct use at Visit 2" divided by "number of participants whose use of the ELLIPTA DPI was evaluated at Visit 2" multiplied by 100. The 95% confidence interval (CI) was calculated using the exact binomial distribution. | At Day 28 |
| Percentage of Participants Who Rated the ELLIPTA DPI as Easy to Use Among Those Who Could Demonstrate Correct Use at Visit 2, Attempt 1 (Day 28) | Participants were trained in the correct use of ELLIPTA DPI at Visit 1 by the HCP and eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on the ease of use of ELLIPTA DPI. For participants in Stratum 1, questionnaire was provided to the interviewer and responses were recorded. For Stratum 2, the questionnaire was self-administered (or interviewer administered, if participant was unable to self-administer). Percentage of participants who rated the ELLIPTA DPI as easy to use was calculated as "number of participants who rate the ELLIPTA as easy" divided by "number of participants who demonstrated correct use at Visit 2 (Attempt #1)" multiplied by 100. The 95% CI for the percentages are calculated using the exact binomial distribution. | At Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 1, Attempt 1 (Day 1) | Participants were trained by HCP in correct use of ELLIPTA DPI at Visit 1 following which participants were assessed on their ability to use the ELLIPTA DPI without guidance from the HCP or parent/guardian. The participants were given a maximum of five attempts. Participants who were unable to use the ELLIPTA DPI correctly were trained by the HCP for the first three attempts. For the fourth and fifth attempts, the participants' parent/guardian assisted in the training of the ELLIPTA DPI. Percentage number of participants who demonstrated correct use of the ELLIPTA DPI along with 95% CI at Visit 1 (attempts 1 to 5) has been presented. The 95% CI for the percentages are calculated using the exact binomial distribution. |
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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 | Little Rock | Arkansas | 72205 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33124762 | Derived | Halverson P, Liem J, Heyes L, Preece A, Bareille P, Rees J, Jain R, Stanford RH, Lenney W, Collison K, Sharma R. The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma. Pediatr Pulmonol. 2021 Jan;56(1):57-64. doi: 10.1002/ppul.25149. Epub 2020 Nov 19. |
| Label | URL |
|---|---|
| 206924 Full Protocol | View source |
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IPD for this study is available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 232 participants were screened, of which 10 failed screening and 222 participants were enrolled in the study. The study was conducted in the United States and Canada.
This was a multi-center, single arm, stratified, open-label, randomized placebo-only study conducted in pediatric participants. Participants were stratified based on age at Visit 0 (Stratum 1: 5 to 7 years old inclusive and Stratum 2: 8 to 11 years old inclusive).
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| ID | Title | Description |
|---|---|---|
| FG000 | Stratum 1: 5-7 Years | Participants received an oral inhalation of placebo once daily via ELLIPTA dry powder inhaler (DPI) for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 23, 2018 | Nov 7, 2019 |
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Subjects from the age group of 5 to 11 years with documented history of symptoms of asthma or diagnosis of asthma for at least 6 months prior to Visit 1 will be assessed for the ease of use of ELLIPTA DPI.
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| ELLIPTA DPI | Device | Subjects will receive placebo DPI via ELLIPTA. ELLIPTA is trademark of GSK |
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| Ease of use questionnaires | Other | Subjects from both stratum after use of ELLIPTA DPI will be randomized to receive either version A or B of the questionnaires. Subjects will be asked questions on ease of use of ELLIPTA. Parent/guardian will also complete a questionnaire about the ELLIPTA DPI. |
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| Day 1 |
| Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 in All Participants (Stratum 1+Stratum 2) | Participants were trained in the correct use of ELLIPTA DPI by a HCP on Day 1 (Visit 1) following which eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on ease of use of ELLIPTA DPI. Participants and their parents/guardian were required to complete the questionnaire, following which participants were assessed for their ability to demonstrate correct use of ELLIPTA DPI (1 attempt with no training or instruction and then 1 attempt after instruction from parent/guardian). Percentage of participants who demonstrated correct use of ELLIPTA was calculated as "number of participants who demonstrated correct use at Visit 2" divided by "number of participants whose use of the ELLIPTA DPI was evaluated at Visit 2" multiplied by 100. The 95% CI was calculated using the exact binomial distribution. | At Day 28 |
| Percentage of Participants Who Rated Easy Use of ELLIPTA DPI at Visit 2 in All Participants (Stratum 1+Stratum 2) | Participants were trained in the correct use of ELLIPTA DPI at Visit 1 by the HCP and eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on the ease of use of ELLIPTA DPI. For participants in Stratum 1, questionnaire was provided to the interviewer and responses were recorded. For Stratum 2, the questionnaire was self-administered (or interviewer administered, if participant was unable to self-administer). Percentage of participants who rated the ELLIPTA DPI as easy to use was calculated as "number of participants who rate the ELLIPTA as easy" divided by "number of participants who demonstrated correct use at Visit 2 (Attempt #1)" multiplied by 100. The 95% CI for the percentages are calculated using the exact binomial distribution. | At Day 28 |
| Percentage of Participants Who Reported at Least One Critical Error From Each Stratum With the Use of ELLIPTA DPI at Visit 1, Attempt 1 | Participants were trained by HCP in correct use of ELLIPTA DPI at Visit 1 following which participants were assessed on their ability to use the ELLIPTA DPI without guidance from the HCP or parent/guardian. The participants were given a maximum of five attempts. Participants who were unable to use the ELLIPTA DPI correctly were trained by the HCP for the first three attempts. For the fourth and fifth attempts, the participants' parent/guardian assisted in the training of the ELLIPTA DPI. Percentage of participants who has withdrawn at any point throughout the correct use demonstration and performed a critical error, was considered as one who performed at least one critical error. Participant who has withdrawn at any point throughout correct use demonstration and did not perform all the critical error items were also considered as one who performed at least one critical error. The 95% CI for the percentages are calculated using the exact binomial distribution. | Day 1 |
| Huntington Beach |
| California |
| 92648 |
| United States |
| GSK Investigational Site | Napa | California | 94558 | United States |
| GSK Investigational Site | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Plantation | Florida | 33324 | United States |
| GSK Investigational Site | Owensboro | Kentucky | 42301 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | United States |
| GSK Investigational Site | Columbia | Missouri | 65203 | United States |
| GSK Investigational Site | Rolla | Missouri | 65401 | United States |
| GSK Investigational Site | Asheville | North Carolina | 28801 | United States |
| GSK Investigational Site | Summerville | South Carolina | 29485 | United States |
| GSK Investigational Site | Austin | Texas | 78759-8950 | United States |
| GSK Investigational Site | Waco | Texas | 76712 | United States |
| GSK Investigational Site | Brampton | Ontario | L6T 0G1 | Canada |
| GSK Investigational Site | Burlington | Ontario | L7N 3V2 | Canada |
| GSK Investigational Site | London | Ontario | N6A 1V2 | Canada |
| GSK Investigational Site | Windsor | Ontario | N8X 2G1 | Canada |
| 206924 Statistical Analysis Plan (SAP) | View source |
| Stratum 2: 8-11 Years |
Participants received an oral inhalation of placebo once daily via ELLIPTA DPI for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stratum 1: 5-7 Years | Participants received an oral inhalation of placebo once daily via ELLIPTA dry powder inhaler (DPI) for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI. |
| BG001 | Stratum 2: 8-11 Years | Participants received an oral inhalation of placebo once daily via ELLIPTA DPI for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI |
| BG002 | Total | Total of all reporting groups |
| 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 | The Intent-to-Treat (ITT) population consists of all participants who have been screened and received at least one dose of the study medication (placebo) | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 (Day 28) | Participants were trained in the correct use of ELLIPTA DPI by a healthcare professional (HCP) on Day 1 (Visit 1) following which eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on ease of use of ELLIPTA DPI. Participants and their parents/guardian were required to complete the questionnaire, following which participants were assessed for their ability to demonstrate correct use of ELLIPTA DPI (1 attempt with no training or instruction and then 1 attempt after instruction from parent/guardian). Percentage of participants who demonstrated correct use of ELLIPTA was calculated as "number of participants who demonstrated correct use at Visit 2" divided by "number of participants whose use of the ELLIPTA DPI was evaluated at Visit 2" multiplied by 100. The 95% confidence interval (CI) was calculated using the exact binomial distribution. | Modified intent to treat (MITT) Population comprised of all participants who were screened, received at least one dose of the study medication (placebo) and were randomized to a version of the ease of use questionnaire at Visit 2. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 28 |
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| Primary | Percentage of Participants Who Rated the ELLIPTA DPI as Easy to Use Among Those Who Could Demonstrate Correct Use at Visit 2, Attempt 1 (Day 28) | Participants were trained in the correct use of ELLIPTA DPI at Visit 1 by the HCP and eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on the ease of use of ELLIPTA DPI. For participants in Stratum 1, questionnaire was provided to the interviewer and responses were recorded. For Stratum 2, the questionnaire was self-administered (or interviewer administered, if participant was unable to self-administer). Percentage of participants who rated the ELLIPTA DPI as easy to use was calculated as "number of participants who rate the ELLIPTA as easy" divided by "number of participants who demonstrated correct use at Visit 2 (Attempt #1)" multiplied by 100. The 95% CI for the percentages are calculated using the exact binomial distribution. | MITT Population. Only those participants who demostrated correct use at Visit 2, attempt 1 has been analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 28 |
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| Secondary | Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 1, Attempt 1 (Day 1) | Participants were trained by HCP in correct use of ELLIPTA DPI at Visit 1 following which participants were assessed on their ability to use the ELLIPTA DPI without guidance from the HCP or parent/guardian. The participants were given a maximum of five attempts. Participants who were unable to use the ELLIPTA DPI correctly were trained by the HCP for the first three attempts. For the fourth and fifth attempts, the participants' parent/guardian assisted in the training of the ELLIPTA DPI. Percentage number of participants who demonstrated correct use of the ELLIPTA DPI along with 95% CI at Visit 1 (attempts 1 to 5) has been presented. The 95% CI for the percentages are calculated using the exact binomial distribution. | ITT Population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
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| Secondary | Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 in All Participants (Stratum 1+Stratum 2) | Participants were trained in the correct use of ELLIPTA DPI by a HCP on Day 1 (Visit 1) following which eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on ease of use of ELLIPTA DPI. Participants and their parents/guardian were required to complete the questionnaire, following which participants were assessed for their ability to demonstrate correct use of ELLIPTA DPI (1 attempt with no training or instruction and then 1 attempt after instruction from parent/guardian). Percentage of participants who demonstrated correct use of ELLIPTA was calculated as "number of participants who demonstrated correct use at Visit 2" divided by "number of participants whose use of the ELLIPTA DPI was evaluated at Visit 2" multiplied by 100. The 95% CI was calculated using the exact binomial distribution. | MITT Population. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 28 |
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| Secondary | Percentage of Participants Who Rated Easy Use of ELLIPTA DPI at Visit 2 in All Participants (Stratum 1+Stratum 2) | Participants were trained in the correct use of ELLIPTA DPI at Visit 1 by the HCP and eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on the ease of use of ELLIPTA DPI. For participants in Stratum 1, questionnaire was provided to the interviewer and responses were recorded. For Stratum 2, the questionnaire was self-administered (or interviewer administered, if participant was unable to self-administer). Percentage of participants who rated the ELLIPTA DPI as easy to use was calculated as "number of participants who rate the ELLIPTA as easy" divided by "number of participants who demonstrated correct use at Visit 2 (Attempt #1)" multiplied by 100. The 95% CI for the percentages are calculated using the exact binomial distribution. | MITT Population. Only those participants who demonstrated correct use at Visit 2, attempt 1 were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 28 |
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| Secondary | Percentage of Participants Who Reported at Least One Critical Error From Each Stratum With the Use of ELLIPTA DPI at Visit 1, Attempt 1 | Participants were trained by HCP in correct use of ELLIPTA DPI at Visit 1 following which participants were assessed on their ability to use the ELLIPTA DPI without guidance from the HCP or parent/guardian. The participants were given a maximum of five attempts. Participants who were unable to use the ELLIPTA DPI correctly were trained by the HCP for the first three attempts. For the fourth and fifth attempts, the participants' parent/guardian assisted in the training of the ELLIPTA DPI. Percentage of participants who has withdrawn at any point throughout the correct use demonstration and performed a critical error, was considered as one who performed at least one critical error. Participant who has withdrawn at any point throughout correct use demonstration and did not perform all the critical error items were also considered as one who performed at least one critical error. The 95% CI for the percentages are calculated using the exact binomial distribution. | ITT Population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
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Serious adverse events (SAEs) and non-SAEs were collected up to Day 28
SAEs and non-SAEs were summarized for the ITT Population. Since all participants received placebo as treatment, data has been combined for all the arms.
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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 | Stratum 1 + Stratum 2 | All participants from Stratum 1 and Stratum 2 (5 to 11 years) were included. | 0 | 222 | 0 | 222 | 11 | 222 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | 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 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2019 | Nov 7, 2019 | SAP_001.pdf |
| 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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| Male |
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| Asian-Japanese Heritage |
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| Asian-South East Asian Heritage |
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| Black Or African American |
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| White-Arabic/North African Heritage |
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| White-White/Caucasian/European Heritage |
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| Multiple |
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| Stratum 2: 8-11 Years |
Participants received an oral inhalation of placebo once daily via ELLIPTA DPI for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI |
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Participants received an oral inhalation of placebo once daily via ELLIPTA DPI for 28 days. At Day 28 (Visit 2), participants received a questionnaire on ease of use of ELLIPTA DPI. Participants were asked questions on ease of use and asked to perform correct use of the ELLIPTA DPI |
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