Pediatric Ease of Use ELLIPTA Items

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.

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