Pediatric Ease of Use ELLIPTA Items
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 1/30/2019 |
| Start Date: | October 17, 2017 |
| End Date: | December 1, 2017 |
Qualitative Research to Support Ellipta Ease-of-Use Questions in Pediatric Patients With Asthma
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.
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.
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:
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