Pediatric Ease of Use ELLIPTA Items

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Asthma

Treatments: Other: Interviewer administered version of ease of use items; Other: Caregiver version of ease of use items; Other: Self-administered version of ease of use items

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03315572

208129

HO-17-18594 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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 design

28 participants in 2 patient groups

Pediatric subject/caregiver dyads-first interview set

Description:

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.

Treatment:

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

Pediatric subject/caregiver dyads-second interview set

Description:

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.

Treatment:

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