An observational study in Asthma, sponsored by GlaxoSmithKline. Completed at 2 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2019-01-28.
Sponsored by GlaxoSmithKline · Observational
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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 21st largest by enrollment of the 24 observational ones that give a count, is one of 16 that started in 2017, is one of 24 observational ones, and was the 223rd 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 and older · 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. 16 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 28 is below the median of 159 across 1,252 observational 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 |
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Among the 261 studies in Asthma by GlaxoSmithKline, from their registry updates:
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A range of devices has been developed to administer inhaled therapy for asthma, including dry powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat asthmatic subjects. The objective of this study is to revise ease of use items developed for adults to be appropriate for completion by pediatric subjects in future clinical trials and to evaluate the newly developed items in subjects with asthma aged 5 to 11 years and their caregivers. This is a cross-sectional, qualitative study that will involve pediatric subjects with asthma who are currently using an asthma maintenance inhaler and their caregivers. Two rounds of repetitive cognitive interviews will be conducted with 16 subjects in each interview set. Each interview will last approximately 45 minutes. Data provided by pediatric subjects and their caregivers during interview will be collected as field notes and audio recordings which will be transcribed.
A convenience sample of pediatric subject and caregiver dyads consisting of pediatric asthmatic subjects aged 5 to 11 years currently using a maintenance inhaler and his or her caregiver will be included.
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.
Child inclusion criteria
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.
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.
The first interview set will consist of eight pediatric subject/caregiver dyads including pediatric subjects with asthma currently using a maintenance inhaler and his or her caregiver. The pediatric subjects and their caregivers will be asked questions regarding ease of use of ELLIPTA inhaler.
Other: Interviewer administered version of ease of use items · Other: Self-administered version of ease of use items · Other: Caregiver version of ease of use items
The second interview set will consist of eight pediatric subject/caregiver dyads including pediatric subjects with asthma currently using a maintenance inhaler and his or her caregiver. The pediatric subjects and their caregivers will be asked questions regarding ease of use of ELLIPTA inhaler.
Other: Interviewer administered version of ease of use items · Other: Self-administered version of ease of use items · Other: Caregiver version of ease of use items
The adult ease of use items will be modified to incorporate language appropriate for pediatric subjects. The interview will be administered by trained clinic-staff for subjects aged 5 to 7 years and those aged 8 to 11 years having difficulty in reading.
The interview will be self-administered by subjects aged 8 to 11 years.
Caregivers will be asked questions regarding their observations and experiences while their child was using ELLIPTA inhaler.
Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews
The items for pediatric participants were developed to assess the concepts of overall ease of use of ELLIPTA and ease of evaluating remaining doses in inhaler. Pediatric participants aged 5 to 7 years were required to complete the interviewer-administered version and participants aged 8 to 11 years were administered self-completed version. Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to assess if the pediatric participants could compare different types of inhalers (Item 3). The number of participants who had problems in understanding the item wordings has been presented. No statistical analyses were conducted for this qualitative study.
Time frame: Up to 45 minutes
Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews
Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c) and 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c). Three response options were developed for these two concepts: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). The number of participants who had difficulty in providing item responses has been presented.
Time frame: Up to 45 minutes
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews
Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to understand if the participants could compare different types of inhalers. Three response options were developed to assess ease of inhaler use and ease of evaluating remaining doses: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). Item 3 consisted of 3 response options (Yes, No, The same). The number of participants who had difficulty in distinguishing item responses has been presented.
Time frame: Up to 45 minutes
Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews
Round 1 of the interviews for caregiver participants evaluated the concepts of ease of evaluating remaining doses (Item 1) and the likelihood of requesting inhaler from their child's physician (Item 2). A response scale with four options was developed for each item: Item 1 (Very easy, Easy, Difficult, Very difficult) and Item 2 (Very likely, Likely, Unlikely, Very unlikely). The number of caregivers who had difficulty in providing responses to caregiver items has been reported.
Time frame: Up to 45 minutes
Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews
Based on the results of Round 1 interviews, the four level verbal response scale (Item 1a and Item 2a) of the pediatric versions were selected for further evaluation of ease of use and ease in evaluating remaining doses in Round 2. The second set of interviews were conducted to test if any further revision is required to optimize the items. The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with problems understanding item wording has been presented.
Time frame: Up to 45 minutes
Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews
The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with difficulty in providing response to items has been presented.
Time frame: Up to 45 minutes
Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews
The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants who had difficulty in distinguishing between the response to items has been presented.
Time frame: Up to 45 minutes
Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews
Based on the results of Round 1 interviews, both the items of caregiver version were retained for further evaluation in Round 2. The number of caregivers who had difficulty in providing responses to caregiver version of items has been presented below.
Time frame: Up to 45 minutes
Number of Additional Ease of Use Items Identified
Caregivers were asked if there were any concepts regarding ease of use that were missing from the pediatric or caregiver versions according to them. The number of ease of use items as identified by caregiver participants has been presented.
Time frame: Up to 45 minutes
Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle
At the end of cognitive debriefing of the items, the interviewers demonstrated how to use the ELLIPTA whistle and then the pediatric participants were provided with a whistle and asked to produce an audible sound. The number of pediatric participants who were able to produce an audible sound using the ELLIPTA whistle has been presented.
Time frame: Up to 45 minutes
Number of Participants With Attempts Required to Produce an Audible Sound
At the end of cognitive debriefing of the items, the pediatric participants were asked to use the ELLIPTA whistle to produce an audible sound. The number of pediatric participants who required one to two attempts or more than three attempts to produce an audible sound has been presented.
Time frame: Up to 45 minutes
This was a cross-sectional, qualitative study to develop items to evaluate ease of use of ELLIPTA by pediatric participants with asthma and their caregivers for implementation in clinical trials.
| Milestone | Pediatric Participants | Caregivers |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
The items for pediatric participants were developed to assess the concepts of overall ease of use of ELLIPTA and ease of evaluating remaining doses in inhaler. Pediatric participants aged 5 to 7 years were required to complete the interviewer-administered version and participants aged 8 to 11 years were administered self-completed version. Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to assess if the pediatric participants could compare different types of inhalers (Item 3). The number of participants who had problems in understanding the item wordings has been presented. No statistical analyses were conducted for this qualitative study.
| Participants | Pediatric Participants (5 to 7 Years) | Pediatric Participants (8 to 11 Years) |
|---|---|---|
| Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews | 0 | 0 |
Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c) and 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c). Three response options were developed for these two concepts: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). The number of participants who had difficulty in providing item responses has been presented.
| Participants | Pediatric Participants (5 to 7 Years) | Pediatric Participants (8 to 11 Years) |
|---|---|---|
| Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews | 0 | 0 |
Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to understand if the participants could compare different types of inhalers. Three response options were developed to assess ease of inhaler use and ease of evaluating remaining doses: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). Item 3 consisted of 3 response options (Yes, No, The same). The number of participants who had difficulty in distinguishing item responses has been presented.
| Participants | Pediatric Participants (5 to 7 Years) | Pediatric Participants (8 to 11 Years) |
|---|---|---|
| Item 1a | 2 | 1 |
| Item 1b | 0 | 0 |
| Item 1c | 0 | 0 |
| Item 2a | 2 | 0 |
| Item 2b | 0 | 0 |
| Item 2c | 0 | 0 |
| Item 3 | 0 | 0 |
Round 1 of the interviews for caregiver participants evaluated the concepts of ease of evaluating remaining doses (Item 1) and the likelihood of requesting inhaler from their child's physician (Item 2). A response scale with four options was developed for each item: Item 1 (Very easy, Easy, Difficult, Very difficult) and Item 2 (Very likely, Likely, Unlikely, Very unlikely). The number of caregivers who had difficulty in providing responses to caregiver items has been reported.
| Participants | Caregivers |
|---|---|
| Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews | 0 |
Based on the results of Round 1 interviews, the four level verbal response scale (Item 1a and Item 2a) of the pediatric versions were selected for further evaluation of ease of use and ease in evaluating remaining doses in Round 2. The second set of interviews were conducted to test if any further revision is required to optimize the items. The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with problems understanding item wording has been presented.
| Participants | Pediatric Participants (5 to 7 Years) | Pediatric Participants (8 to 11 Years) |
|---|---|---|
| Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews | 0 | 0 |
The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with difficulty in providing response to items has been presented.
| Participants | Pediatric Participants (5 to 7 Years) | Pediatric Participants (8 to 11 Years) |
|---|---|---|
| Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews | 0 | 0 |
The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants who had difficulty in distinguishing between the response to items has been presented.
| Participants | Pediatric Participants (5 to 7 Years) | Pediatric Participants (8 to 11 Years) |
|---|---|---|
| Item 1 | 1 | 0 |
| Item 2 | 0 | 0 |
| Item 3 | 0 | 0 |
Based on the results of Round 1 interviews, both the items of caregiver version were retained for further evaluation in Round 2. The number of caregivers who had difficulty in providing responses to caregiver version of items has been presented below.
| Participants | Caregivers |
|---|---|
| Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews | 0 |
Caregivers were asked if there were any concepts regarding ease of use that were missing from the pediatric or caregiver versions according to them. The number of ease of use items as identified by caregiver participants has been presented.
| Items | Caregivers |
|---|---|
| Number of Additional Ease of Use Items Identified | 0 |
At the end of cognitive debriefing of the items, the interviewers demonstrated how to use the ELLIPTA whistle and then the pediatric participants were provided with a whistle and asked to produce an audible sound. The number of pediatric participants who were able to produce an audible sound using the ELLIPTA whistle has been presented.
| Participants | Pediatric Participants (5 to 7 Years) | Pediatric Participants (8 to 11 Years) |
|---|---|---|
| Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle | 6 | 8 |
At the end of cognitive debriefing of the items, the pediatric participants were asked to use the ELLIPTA whistle to produce an audible sound. The number of pediatric participants who required one to two attempts or more than three attempts to produce an audible sound has been presented.
| Participants | Pediatric Participants (5 to 7 Years) | Pediatric Participants (8 to 11 Years) |
|---|---|---|
| One to two attempts | 4 | 7 |
| More than three attempts | 2 | 1 |
Collected over Adverse events (AEs) were not collected as this is a prospective study that utilized primary data collection without a GlaxoSmithKline drug of interest.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pediatric Participants | — | — | — |
| Caregivers | — | — | — |
All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
| Age, Continuous(Years) | Pediatric Participants | Caregivers | Total |
|---|---|---|---|
| Mean | 8 ± 1.6 | 38.1 ± 7.1 | 23.05 ± 4.35 |
| Sex: Female, Male(Participants) | Pediatric Participants | Caregivers | Total |
|---|---|---|---|
| Female | 4 | 12 | 16 |
| Male | 10 | 2 | 12 |
| Race/Ethnicity, Customized(Participants) | Pediatric Participants | Caregivers | Total |
|---|---|---|---|
| Race customized — White | 5 | 6 | 11 |
| Race customized — Black | 6 | 6 | 12 |
| Race customized — Asian or other | 3 | 2 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in Dec 2017, 1 month.
Results were first posted in Jan 2019, 1 year 1 month after primary completion.
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