Study Results
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View full resultsBasic Information
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COMPLETED
28 participants
OBSERVATIONAL
2017-10-17
2017-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
5 Years
ALL
No
Sponsors
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RTI Health Solutions(RTI HS)
UNKNOWN
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Southfield, Michigan, United States
GSK Investigational Site
Raleigh, North Carolina, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HO-17-18594
Identifier Type: OTHER
Identifier Source: secondary_id
208129
Identifier Type: -
Identifier Source: org_study_id
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