Pediatric Ease of Use ELLIPTA Items

Asthma Clinical Trial

Official title:

Qualitative Research to Support Ellipta Ease-of-Use Questions in Pediatric Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315572
• Other study ID #: 208129
• Secondary ID: HO-17-18594
• Status: Completed
• Start date: October 17, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: August 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Interviewer administered 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.
• Self-administered version of ease of use items
The interview will be self-administered by subjects aged 8 to 11 years.
• Caregiver version of ease of use items
Caregivers will be asked questions regarding their observations and experiences while their child was using ELLIPTA inhaler.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Southfield	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	RTI Health Solutions(RTI HS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 45 minutes
Primary	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.	Up to 45 minutes
Primary	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.	Up to 45 minutes
Primary	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.	Up to 45 minutes
Primary	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.	Up to 45 minutes
Primary	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.	Up to 45 minutes
Primary	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.	Up to 45 minutes
Primary	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.	Up to 45 minutes
Primary	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.	Up to 45 minutes
Secondary	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.	Up to 45 minutes
Secondary	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.	Up to 45 minutes