NCT03315572

Pediatric Ease of Use ELLIPTA Items

Completed Results posted Last updated 28 January 2019

What this trial tests

trial testing Interviewer administered version of ease of use items in Asthma in 28 participants. Completed in 1 December 2017.

Timeline

17 October 2017

Primary endpoint
1 December 2017

1 December 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Status	Completed
Study type	OBSERVATIONAL
Enrollment	28
Start date	17 October 2017
Primary completion	1 December 2017
Estimated completion	1 December 2017
Sites	2 locations across United States

Drugs / interventions tested

• Interviewer administered version of ease of use items
• Self-administered version of ease of use items
• Caregiver version of ease of use items

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

5 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews Primary · Up to 45 minutes

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 typ

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews Primary · Up to 45 minutes

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 pres

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews Primary · Up to 45 minutes

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 verba

Item 1a

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	2
Pediatric Participants (8 to 11 Years)	1

Item 1b

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Item 1c

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Item 2a

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	2
Pediatric Participants (8 to 11 Years)	0

Item 2b

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Item 2c

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Item 3

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews Primary · Up to 45 minutes

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.

Group	Value	95% CI
Caregivers	0

Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews Primary · Up to 45 minutes

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

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews Primary · Up to 45 minutes

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.

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews Primary · Up to 45 minutes

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.

Item 1

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	1
Pediatric Participants (8 to 11 Years)	0

Item 2

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Item 3

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	0
Pediatric Participants (8 to 11 Years)	0

Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews Primary · Up to 45 minutes

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.

Group	Value	95% CI
Caregivers	0

Number of Additional Ease of Use Items Identified Primary · Up to 45 minutes

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.

Group	Value	95% CI
Caregivers	0

Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle Secondary · Up to 45 minutes

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.

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	6
Pediatric Participants (8 to 11 Years)	8

Number of Participants With Attempts Required to Produce an Audible Sound Secondary · Up to 45 minutes

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.

One to two attempts

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	4
Pediatric Participants (8 to 11 Years)	7

More than three attempts

Group	Value	95% CI
Pediatric Participants (5 to 7 Years)	2
Pediatric Participants (8 to 11 Years)	1

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma.
   Halverson P, Liem J, Heyes L, Preece A, et al · · 2021 · cited 2× · PMID 33124762 · DOI 10.1002/ppul.25149