NCT03315572

Pediatric Ease of Use ELLIPTA Items

Qualitative Research to Support Ellipta Ease-of-Use Questions in Pediatric Patients With Asthma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	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.
OTHER	Self-administered version of ease of use items	The interview will be self-administered by subjects aged 8 to 11 years.
OTHER	Caregiver version of ease of use items	Caregivers will be asked questions regarding their observations and experiences while their child was using ELLIPTA inhaler.

Timeline

• Start date: 2017-10-17
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2017-10-20
• Last updated: 2019-01-28
• Results posted: 2019-01-28

Locations

2 sites across 1 country: United States