Last updated: 11/04/2018 00:32:33
Pediatric Ease of Use ELLIPTA Items
GSK study ID
208129
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2017-01-12
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
GSK Investigational Site
Southfield, Michigan, United States, 48034
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
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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