Last updated: 11/04/2018 00:32:33

Pediatric Ease of Use ELLIPTA Items

GSK study ID
208129
Clinicaltrials.gov ID
NCT03315572
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Qualitative Research to Support Ellipta Ease-of-Use Questions in Pediatric Patients with Asthma
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of pediatric participants with problems understanding item wording-Round 1 interviews

Timeframe: Up to 45 minutes

Number of pediatric participants with difficulty providing responses to items-Round 1 interviews

Timeframe: Up to 45 minutes

Number of pediatric participants with difficulty in distinguishing between the item responses-Round 1 interviews

Timeframe: Up to 45 minutes

Number of caregiver participants who had difficulty providing responses to caregiver items-Round 1 interviews

Timeframe: Up to 45 minutes

Number of pediatric participants with problems understanding item wording-Round 2 interviews

Timeframe: Up to 45 minutes

Number of pediatric participants with difficulty providing responses to items-Round 2 interviews

Timeframe: Up to 45 minutes

Number of pediatric participants with difficulty in distinguishing between the responses to items-Round 2 interviews

Timeframe: Up to 45 minutes

Number of caregiver participants who had difficulty providing responses to caregiver items-Round 2 interviews

Timeframe: Up to 45 minutes

Number of additional ease of use items identified

Timeframe: Up to 45 minutes

Secondary outcomes:

Number of pediatric participants who were able to use ELLIPTA whistle

Timeframe: Up to 45 minutes

Number of participants with attempts required to produce an audible sound

Timeframe: Up to 45 minutes

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
    Primary completion date:
    2017-01-12
    Observational study model:
    Cohort
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
    Collaborators
    RTI Health Solutions(RTI HS)
    Study date(s)
    October 2017 to December 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    5+ years
    Accepts healthy volunteers
    No
    • Child inclusion criteria
    • Be 5 to 11 years of age
    • Nil
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Southfield, Michigan, United States, 48034
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27612
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2017-01-12
    Actual study completion date
    2017-01-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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