Trial Outcomes & Findings for Pediatric Ease of Use ELLIPTA Items (NCT NCT03315572)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

Up to 45 minutes

Results posted on

2019-01-28

Participant Flow

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.

Two iterative rounds of interviews were conducted in 14 dyads, each containing one caregiver and one pediatric participant with asthma (a total of 28 participants). All the interviews were conducted in Raleigh, North Carolina and Southfield, Michigan.

Participant milestones

Participant milestones
Measure	Pediatric Participants Pediatric participants with asthma in the age range of 5 to 11 years were included.	Caregivers The parents or legal guardians of participants with asthma were included.
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pediatric Participants n=14 Participants Pediatric participants with asthma in the age range of 5 to 11 years were included.	Caregivers n=14 Participants The parents or legal guardians of participants with asthma were included.	Total n=28 Participants Total of all reporting groups
Age, Continuous	8 Years STANDARD_DEVIATION 1.6 • n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	38.1 Years STANDARD_DEVIATION 7.1 • n=7 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	23.05 Years STANDARD_DEVIATION 4.35 • n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
Sex: Female, Male Female	4 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	12 Participants n=7 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	16 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
Sex: Female, Male Male	10 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	2 Participants n=7 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	12 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
Race/Ethnicity, Customized Race customized · White	5 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	6 Participants n=7 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	11 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
Race/Ethnicity, Customized Race customized · Black	6 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	6 Participants n=7 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	12 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
Race/Ethnicity, Customized Race customized · Asian or other	3 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	2 Participants n=7 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.	5 Participants n=5 Participants • All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.

PRIMARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only those pediatric participants who participated in Round 1 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=3 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) n=5 Participants Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only those pediatric participants who participated in Round 1 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=3 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) n=5 Participants Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only those pediatric participants who participated in Round 1 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=3 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) n=5 Participants Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews Item 1a	2 Participants	1 Participants
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews Item 1b	0 Participants	0 Participants
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews Item 1c	0 Participants	0 Participants
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews Item 2a	2 Participants	0 Participants
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews Item 2b	0 Participants	0 Participants
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews Item 2c	0 Participants	0 Participants
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews Item 3	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only those caregiver participants who participated in Round 1 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=8 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews	0 Participants	—

PRIMARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only those pediatric participants who participated in Round 2 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=3 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) n=3 Participants Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only those pediatric participants who participated in Round 2 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=3 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) n=3 Participants Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only those pediatric participants who participated in Round 2 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=3 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) n=3 Participants Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews Item 1	1 Participants	0 Participants
Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews Item 2	0 Participants	0 Participants
Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews Item 3	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only those caregiver participants who participated in Round 2 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=6 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews	0 Participants	—

PRIMARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only those caregiver participants who participated in Round 1 and Round 2 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=14 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Additional Ease of Use Items Identified	0 Items	—

SECONDARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only pediatric participants who participated in Round 1 and Round 2 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=6 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) n=8 Participants Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle	6 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 45 minutes

Population: All enrolled population. Only pediatric participants who participated in Round 1 and Round 2 of the interviews were assessed.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants (5 to 7 Years) n=6 Participants Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.	Pediatric Participants (8 to 11 Years) n=8 Participants Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Number of Participants With Attempts Required to Produce an Audible Sound One to two attempts	4 Participants	7 Participants
Number of Participants With Attempts Required to Produce an Audible Sound More than three attempts	2 Participants	1 Participants

Adverse Events

Pediatric Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER