Clinical trial NCT03315572: Pediatric Ease of Use ELLIPTA Items
Official title: Qualitative Research to Support Ellipta Ease-of-Use Questions in Pediatric Patients With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: caregiver
ELLIPTA
Asthma
Dry Powder Inhaler
pediatric
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: RTI Health Solutions(RTI HS)
First posted: 2017-10-20
Enrollment: 28
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of pediatric subject and caregiver dyads consisting of pediatric asthmatic subjects aged 5 to 11 years currently using a maintenance inhaler and his or her caregiver will be included.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews
timeFrame: Up to 45 minutes
measure: Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews
timeFrame: Up to 45 minutes
measure: Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews
timeFrame: Up to 45 minutes
measure: Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews
timeFrame: Up to 45 minutes
measure: Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews
timeFrame: Up to 45 minutes
measure: Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews
timeFrame: Up to 45 minutes
measure: Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews
timeFrame: Up to 45 minutes
measure: Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews
timeFrame: Up to 45 minutes
measure: Number of Additional Ease of Use Items Identified
timeFrame: Up to 45 minutes
Secondary outcomes:
measure: Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle
timeFrame: Up to 45 minutes
measure: Number of Participants With Attempts Required to Produce an Audible Sound
timeFrame: Up to 45 minutes
Other outcomes:
Locations:
city: Southfield
country: United States
facility: GSK Investigational Site
state: Michigan
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Halverson P, Liem J, Heyes L, Preece A, Bareille P, Rees J, Jain R, Stanford RH, Lenney W, Collison K, Sharma R. The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma. Pediatr Pulmonol. 2021 Jan;56(1):57-64. doi: 10.1002/ppul.25149. Epub 2020 Nov 19.