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Pediatric Ease of Use ELLIPTA Items

NCT03315572 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2019-01-28

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • RTI Health Solutions(RTI HS)

    collaborator UNKNOWN

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03315572 on ClinicalTrials.gov