N/A
N=28
Pediatric Ease of Use ELLIPTA Items
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03315572 ↗Enrolled (actual)
28
Serious AEs
—
Results posted
Jan 2019
Primary outcome: Primary: Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews — 0; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 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 (Other)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews |
0; 0 | — |
| PRIMARY Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews |
0; 0 | — |
| PRIMARY Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews |
2; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews |
— | — |
| PRIMARY Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews |
0; 0 | — |
| PRIMARY Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews |
0; 0 | — |
| PRIMARY Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews |
— | — |
| PRIMARY Number of Additional Ease of Use Items Identified |
— | — |
| SECONDARY Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle |
6; 8 | — |
| SECONDARY Number of Participants With Attempts Required to Produce an Audible Sound |
4; 7; 2; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
Child inclusion criteria
- Be 5 to 11 years of age
- Have asthma
- Currently use a maintenance inhaler to treat their asthma
- Be willing and able to provide assent
- Be willing and able to participate in a 45-minute interview in English Caregiver inclusion criteria
- Above 18+ years of age
- Be a caregiver (parent or legal guardian) of a pediatric subject with asthma that meets the criteria above
- Be willing and able to provide signed and dated informed consent and parental permission in English
- Be willing and able to participate in a 45-minute interview
Exclusion Criteria
- Nil
Data sourced from ClinicalTrials.gov (NCT03315572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.