A Phase 4 interventional study of Placebo DPI and ELLIPTA DPI in Asthma, sponsored by GlaxoSmithKline. Completed at 19 sites in 2 countries. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2021-03-26.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
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Among 261 studies in Asthma by GlaxoSmithKline — 7 open to participants now, 12 under way, 7 of them phase 3. Asthma · GlaxoSmithKline.
Among the 261 studies in Asthma by GlaxoSmithKline, this one is the 90th largest by enrollment of the 237 interventional ones that give a count, is one of 9 that started in 2018, is one of 53 in phase 4, and was the 230th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →7 of the 261 studies in Asthma by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Argentina, Canada and 1 more country
Ages 18+
GlaxoSmithKline · Sites in United States
Ages 12–80
GlaxoSmithKline · Sites in United States, Japan
Ages 12–80
GlaxoSmithKline · Sites in United States
Ages 6–11
GlaxoSmithKline · Sites in United States, United Kingdom
Ages 12+
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 5 Years to 11 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
261 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 63 · Phase 2 59 · Phase 3 61 · Phase 4 53
First in 1999; this study’s year is marked. 9 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 222 is above the median of 79 across 3,344 interventional studies indexed under Asthma.
Median enrollment 100 across the 237 interventional studies, 512 across the 24 observational. Of the 239 that completed or were terminated, 131 (55%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
5 of the studies in Asthma by GlaxoSmithKline that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07645248Phase 3GlaxoSmithKlineA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a) | 2026-12-28 |
| NCT05757102Phase 3GlaxoSmithKlineA Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma | 2027-01-26 |
| NCT07671001Phase 3GlaxoSmithKlineA Study of Depemokimab in Participants of 6 to 11 Years of Age | 2027-03-01 |
| NCT07712393GlaxoSmithKlineA Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283 | 2027-04-13 |
| NCT06433921GlaxoSmithKlineA Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive | 2027-04-16 |
Add all 5 to your calendar (.ics) → With an account.
Among the 261 studies in Asthma by GlaxoSmithKline, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Placebo DPI · Device: ELLIPTA DPI · Other: Ease of use questionnaires
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.
Subjects will receive placebo DPI via ELLIPTA. ELLIPTA is trademark of GSK
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.
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.
Time frame: 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.
Time frame: At Day 28
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
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).
| Milestone | Stratum 1: 5-7 Years | Stratum 2: 8-11 Years |
|---|---|---|
| Started | 88 | 134 |
| Completed | 88 | 133 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| Percentage of participants | Stratum 1: 5-7 Years | Stratum 2: 8-11 Years |
|---|---|---|
| Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 (Day 28) | 92 (84 to 97) | 93 (88 to 97) |
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.
| Percentage of participants | Stratum 1: 5-7 Years | Stratum 2: 8-11 Years |
|---|---|---|
| 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) | 98 (91 to 99) | 98 (93 to 99) |
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.
| Percentage of participants | Stratum 1: 5-7 Years | Stratum 2: 8-11 Years |
|---|---|---|
| Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 1, Attempt 1 (Day 1) | 24 (15 to 34) | 50 (41 to 59) |
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.
| Percentage of participants | Stratum 1 + Stratum 2 |
|---|---|
| Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 in All Participants (Stratum 1+Stratum 2) | 93 (89 to 96) |
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.
| Percentage of participants | Stratum 1 + Stratum 2 |
|---|---|
| Percentage of Participants Who Rated Easy Use of ELLIPTA DPI at Visit 2 in All Participants (Stratum 1+Stratum 2) | 98 (94 to 99) |
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.
| Percentage of participants | Stratum 1: 5-7 Years | Stratum 2: 8-11 Years |
|---|---|---|
| Percentage of Participants Who Reported at Least One Critical Error From Each Stratum With the Use of ELLIPTA DPI at Visit 1, Attempt 1 | 51 (40 to 62) | 25 (18 to 34) |
Collected over Serious adverse events (SAEs) and non-SAEs were collected up to Day 28. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stratum 1 + Stratum 2 | 0/222 (0%) | 0/222 (0%) | 11/222 (5%) |
| Event | Stratum 1 + Stratum 2 |
|---|---|
| Viral upper respiratory tract infectionInfections and infestations | 5/222 |
| Upper respiratory tract infectionInfections and infestations | 3/222 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/222 |
| Age, Continuous(Years) | Stratum 1: 5-7 Years | Stratum 2: 8-11 Years | Total |
|---|---|---|---|
| Mean | 6.1 ± 0.80 | 9.7 ± 1.10 | 8.3 ± 2.02 |
| Sex: Female, Male(Participants) | Stratum 1: 5-7 Years | Stratum 2: 8-11 Years | Total |
|---|---|---|---|
| Female | 41 | 48 | 89 |
| Male | 47 | 86 | 133 |
| Race/Ethnicity, Customized(Participants) | Stratum 1: 5-7 Years | Stratum 2: 8-11 Years | Total |
|---|---|---|---|
| Asian-Central/South Asian Heritage | 5 | 11 | 16 |
| Asian-Japanese Heritage | 0 | 1 | 1 |
| Asian-South East Asian Heritage | 2 | 1 | 3 |
| Black Or African American | 24 | 37 | 61 |
| White-Arabic/North African Heritage | 4 | 1 | 5 |
| White-White/Caucasian/European Heritage | 49 | 75 | 124 |
| Multiple | 4 | 8 | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access criteria: 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.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Jun 2018 to primary completion in Dec 2018, 5 months.
Results were first posted in Dec 2019, 1 year after primary completion.
Of 66 industry-sponsored phase 4 interventional studies under Asthma, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 33. This study's 5 months is below that.
Counting every sponsor, half of 156 studies reached it within 24 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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