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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

Tracking Information
First Submitted Date October 17, 2017
First Posted Date October 20, 2017
Results First Submitted Date April 25, 2018
Results First Posted Date January 28, 2019
Last Update Posted Date January 28, 2019
Actual Study Start Date October 17, 2017
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 2018)
  • Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews [ Time Frame: 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 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.
  • Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews [ Time Frame: 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 presented.
  • Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews [ Time Frame: 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 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.
  • Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews [ Time Frame: 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.
  • Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews [ Time Frame: 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 differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with problems understanding item wording has been presented.
  • Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews [ Time Frame: 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.
  • Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews [ Time Frame: 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.
  • Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews [ Time Frame: 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.
  • Number of Additional Ease of Use Items Identified [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: October 17, 2017)
  • Number of pediatric subjects having initial problems with item wording [ Time Frame: Approximately 45 minutes ]
    The items to assess ease of inhaler use by pediatric subjects aged 5 to 11 years will be evaluated. The first set of interviews will identify any initial problems the pediatric subjects have with wording of the items.
  • Number of caregivers having initial problems with item wording [ Time Frame: Approximately 45 minutes ]
    The items to assess ease of inhaler use by pediatric subjects aged 5 to 11 years and their caregivers will be evaluated. The first set of interviews will identify any initial problems that the caregivers have with wording of the items.
  • Number of pediatric subjects having initial problems with response options [ Time Frame: Approximately 45 minutes ]
    The items to assess ease of inhaler use by pediatric subjects aged 5 to 11 years and their caregivers will be evaluated. The first set of interviews will identify any initial problems with response options provided for the items.
  • Number of caregivers having initial problems with response options [ Time Frame: Approximately 45 minutes ]
    The items to assess ease of inhaler use by pediatric subjects aged 5 to 11 years and their caregivers will be evaluated. The first set of interviews will identify any initial problems with response options provided for the items.
  • Number of subjects with proposed mode of administration of interview [ Time Frame: Approximately 45 minutes ]
    The different modes of interview administration will be assessed to evaluate the proposed mode of administration by age group.
  • Number of pediatric subjects reported requirements of revisions to optimize the ease of use items [ Time Frame: Approximately 45 minutes ]
    The second set of interviews will identify whether the ease of use items need to be further revised before implementation in the clinical trial.
  • Number of caregivers reported requirements of revisions to optimize the ease of use items [ Time Frame: Approximately 45 minutes ]
    The second set of interviews will identify whether the ease of use items need to be further revised before implementation in the clinical trial.
  • Number of pediatric subject reported additional concept [ Time Frame: Approximately 45 minutes ]
    The interviews will identify any additional concepts that the pediatric subjects think should be addressed regarding ease of use (if any).
  • Number of caregiver reported additional concept [ Time Frame: Approximately 45 minutes ]
    The interviews will identify any additional concepts that the pediatric subjects think should be addressed regarding ease of use (if any).
Change History Complete list of historical versions of study NCT03315572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 9, 2018)
  • Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle [ Time Frame: 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.
  • Number of Participants With Attempts Required to Produce an Audible Sound [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: October 17, 2017)
  • Number of pediatric subjects who are able to produce an audible sound using the ELLIPTA whistle [ Time Frame: Approximately 45 minutes ]
    The ability of pediatric subjects aged 5 to 11 years to produce an audible sound while breathing in using the ELLIPTA whistle will be evaluated.
  • Number of attempts required by the subjects to produce an audible sound [ Time Frame: Approximately 45 minutes ]
    The number of attempts required by the pediatric subjects to produce an audible sound using the ELLIPTA whistle will be reported.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pediatric Ease of Use ELLIPTA Items
Official Title Qualitative Research to Support Ellipta Ease-of-Use Questions in Pediatric Patients With Asthma
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
  • Other: Self-administered version of ease of use items
    The interview will be self-administered by subjects aged 8 to 11 years.
  • Other: Caregiver version of ease of use items
    Caregivers will be asked questions regarding their observations and experiences while their child was using ELLIPTA inhaler.
Study Groups/Cohorts
  • 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.
    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
  • 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.
    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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 23, 2018)
28
Original Estimated Enrollment
 (submitted: October 17, 2017)
32
Actual Study Completion Date December 1, 2017
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • Nil
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03315572
Other Study ID Numbers 208129
HO-17-18594 ( Other Identifier: Track HO identifier )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators RTI Health Solutions(RTI HS)
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2018