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Pediatric Ease of Use ELLIPTA Items

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ClinicalTrials.gov Identifier: NCT03315572
Recruitment Status : Completed
First Posted : October 20, 2017
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
RTI Health Solutions(RTI HS)
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Asthma
Interventions 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
Enrollment 28
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Pediatric Participants Caregivers
Hide Arm/Group Description Pediatric participants with asthma in the age range of 5 to 11 years were included. The parents or legal guardians of participants with asthma were included.
Period Title: Overall Study
Started 14 14
Completed 14 14
Not Completed 0 0
Arm/Group Title Pediatric Participants Caregivers Total
Hide Arm/Group Description Pediatric participants with asthma in the age range of 5 to 11 years were included. The parents or legal guardians of participants with asthma were included. Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
8  (1.6) 38.1  (7.1) 23.05  (4.35)
[1]
Measure Analysis Population Description: All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
4
  28.6%
12
  85.7%
16
  57.1%
Male
10
  71.4%
2
  14.3%
12
  42.9%
[1]
Measure Analysis Population Description: All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race customized Number Analyzed 14 participants 14 participants 28 participants
White
5
  35.7%
6
  42.9%
11
  39.3%
Black
6
  42.9%
6
  42.9%
12
  42.9%
Asian or other
3
  21.4%
2
  14.3%
5
  17.9%
[1]
Measure Analysis Population Description: All Enrolled Population: Includes all pediatric participants and their caregivers who participated in Round 1 and Round 2 of interviews.
1.Primary Outcome
Title Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only those pediatric participants who participated in Round 1 of the interviews were assessed.
Arm/Group Title Pediatric Participants (5 to 7 Years) Pediatric Participants (8 to 11 Years)
Hide Arm/Group Description:
Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.
Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Overall Number of Participants Analyzed 3 5
Measure Type: Number
Unit of Measure: Participants
0 0
2.Primary Outcome
Title Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only those pediatric participants who participated in Round 1 of the interviews were assessed.
Arm/Group Title Pediatric Participants (5 to 7 Years) Pediatric Participants (8 to 11 Years)
Hide Arm/Group Description:
Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.
Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Overall Number of Participants Analyzed 3 5
Measure Type: Number
Unit of Measure: Participants
0 0
3.Primary Outcome
Title Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only those pediatric participants who participated in Round 1 of the interviews were assessed.
Arm/Group Title Pediatric Participants (5 to 7 Years) Pediatric Participants (8 to 11 Years)
Hide Arm/Group Description:
Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.
Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Overall Number of Participants Analyzed 3 5
Measure Type: Number
Unit of Measure: Participants
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
4.Primary Outcome
Title Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only those caregiver participants who participated in Round 1 of the interviews were assessed.
Arm/Group Title Caregivers
Hide Arm/Group Description:
Caregivers of pediatric participants with asthma were included. Participants were required to complete caregiver version of ease of use items.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
0
5.Primary Outcome
Title Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only those pediatric participants who participated in Round 2 of the interviews were assessed.
Arm/Group Title Pediatric Participants (5 to 7 Years) Pediatric Participants (8 to 11 Years)
Hide Arm/Group Description:
Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.
Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: Participants
0 0
6.Primary Outcome
Title Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only those pediatric participants who participated in Round 2 of the interviews were assessed.
Arm/Group Title Pediatric Participants (5 to 7 Years) Pediatric Participants (8 to 11 Years)
Hide Arm/Group Description:
Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.
Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: Participants
0 0
7.Primary Outcome
Title Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only those pediatric participants who participated in Round 2 of the interviews were assessed.
Arm/Group Title Pediatric Participants (5 to 7 Years) Pediatric Participants (8 to 11 Years)
Hide Arm/Group Description:
Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.
Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: Participants
Item 1 1 0
Item 2 0 0
Item 3 0 0
8.Primary Outcome
Title Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only those caregiver participants who participated in Round 2 of the interviews were assessed.
Arm/Group Title Caregivers
Hide Arm/Group Description:
Caregivers of pediatric participants with asthma were included. Participants were required to complete caregiver version of ease of use items.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
0
9.Primary Outcome
Title Number of Additional Ease of Use Items Identified
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only those caregiver participants who participated in Round 1 and Round 2 of the interviews were assessed.
Arm/Group Title Caregivers
Hide Arm/Group Description:
Caregivers of pediatric participants with asthma were included. Participants were required to complete caregiver version of ease of use items.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Items
0
10.Secondary Outcome
Title Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only pediatric participants who participated in Round 1 and Round 2 of the interviews were assessed.
Arm/Group Title Pediatric Participants (5 to 7 Years) Pediatric Participants (8 to 11 Years)
Hide Arm/Group Description:
Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.
Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Overall Number of Participants Analyzed 6 8
Measure Type: Number
Unit of Measure: Participants
6 8
11.Secondary Outcome
Title Number of Participants With Attempts Required to Produce an Audible Sound
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled population. Only pediatric participants who participated in Round 1 and Round 2 of the interviews were assessed.
Arm/Group Title Pediatric Participants (5 to 7 Years) Pediatric Participants (8 to 11 Years)
Hide Arm/Group Description:
Participants with asthma in the age range of 5 to 7 years were included. Participants were required to complete the interviewer administered items.
Participants with asthma in the age range of 8 to 11 years were included. Participants were administered self-completion items.
Overall Number of Participants Analyzed 6 8
Measure Type: Number
Unit of Measure: Participants
One to two attempts 4 7
More than three attempts 2 1
Time Frame Adverse events (AEs) were not collected as this is a prospective study that utilized primary data collection without a GlaxoSmithKline drug of interest.
Adverse Event Reporting Description AEs and SAEs were not collected.
 
Arm/Group Title Pediatric Participants Caregivers
Hide Arm/Group Description Pediatric participants with asthma in the age range of 5 to 11 years were included. The parents or legal guardians of participants with asthma were included.
All-Cause Mortality
Pediatric Participants Caregivers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Pediatric Participants Caregivers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pediatric Participants Caregivers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03315572     History of Changes
Other Study ID Numbers: 208129
HO-17-18594 ( Other Identifier: Track HO identifier )
First Submitted: October 17, 2017
First Posted: October 20, 2017
Results First Submitted: April 25, 2018
Results First Posted: January 28, 2019
Last Update Posted: January 28, 2019