Pediatric Ease of Use ELLIPTA Items

NCT03315572 | Completed Results

• 2 other identifiers: 208129HO-17-18594
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Asthma

Keywords

caregiver; ELLIPTA; Asthma; Dry Powder Inhaler; pediatric

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle

  Up to 45 minutes

• Number of Participants With Attempts Required to Produce an Audible Sound

  Up to 45 minutes

Study Arms (2)

Pediatric subject/caregiver dyads-first interview set

The first interview set will consist of eight pediatric subject/caregiver dyads including pediatric subjects with asthma currently using a maintenance inhaler and his or her caregiver. The pediatric subjects and their caregivers will be asked questions regarding ease of use of ELLIPTA inhaler.

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

Pediatric subject/caregiver dyads-second interview set

The second interview set will consist of eight pediatric subject/caregiver dyads including pediatric subjects with asthma currently using a maintenance inhaler and his or her caregiver. The pediatric subjects and their caregivers will be asked questions regarding ease of use of ELLIPTA inhaler.

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

Interventions

Interviewer administered version of ease of use items OTHER

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.

Pediatric subject/caregiver dyads-first interview set; Pediatric subject/caregiver dyads-second interview set

Self-administered version of ease of use items OTHER

The interview will be self-administered by subjects aged 8 to 11 years.

Pediatric subject/caregiver dyads-first interview set; Pediatric subject/caregiver dyads-second interview set

Caregiver version of ease of use items OTHER

Caregivers will be asked questions regarding their observations and experiences while their child was using ELLIPTA inhaler.

Pediatric subject/caregiver dyads-first interview set; Pediatric subject/caregiver dyads-second interview set

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of pediatric subject and caregiver dyads consisting of pediatric asthmatic subjects aged 5 to 11 years currently using a maintenance inhaler and his or her caregiver will be included.

You may qualify if:

• 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
• 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

You may not qualify if:

• Nil

Sponsors & Collaborators

• GlaxoSmithKline: lead
• RTI Health Solutions(RTI HS): collaborator

Study Sites (2)

GSK Investigational Site

Southfield, Michigan, 48034, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Related Publications (1)

• Halverson P, Liem J, Heyes L, Preece A, Bareille P, Rees J, Jain R, Stanford RH, Lenney W, Collison K, Sharma R. The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma. Pediatr Pulmonol. 2021 Jan;56(1):57-64. doi: 10.1002/ppul.25149. Epub 2020 Nov 19.

  PMID: 33124762 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 20, 2017
• Study Start: October 17, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2018-08

Locations

US (2)