Qualitative Research to Explore Patient Preference for Modes of Administration in Pulmonary Arterial Hypertension Treatments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of subjects who preferred subcutaneous injection versus current treatment options
Study Overview
Brief Summary
GlaxoSmithKline (GSK) is embarking on a clinical program to assess the treatment of PAH with an Angiotensin converting enzyme 2 (ACE2). This new treatment may require subcutaneous administration, in comparison to current treatments which are taken orally. Hence, GSK would like to conduct this qualitative interview study with PAH subjects to explore subject's perspective and preferences for various modes of treatment administration (daily or weekly subcutaneous injection versus current treatment options). This will be a qualitative study comprising the conduct of semi-structured telephone concept elicitation interviews with 8 to 10 PAH subjects (each approximately 30 minutes in duration) in the United States (US).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, at least 18 years of age.
- •Subject is willing and able to provide written informed consent.
- •Subject must have a diagnosis of symptomatic Pulmonary Arterial Hypertension Type I as per the World Health Organization (WHO) clinical classification system.
- •Subject must have the cognitive and linguistic capabilities sufficient to allow them to actively participate in an interview lasting 30 minutes.
Exclusion Criteria
- •Subject has a diagnosis of other cardiac or pulmonary disease.
- •Subject has a Type II-V diagnosis of PAH, as per the WHO clinical classification system.
- •Subject is currently receiving treatment for PAH via modes of administration other than intravenously or orally.
Outcomes
Primary Outcomes
Number of subjects who preferred subcutaneous injection versus current treatment options
Time Frame: Up to 30 minutes
All recruited subjects will take part in a 30-minute telephone interview. Subjects will be given brief descriptions of hypothetical injection and inhaled treatments and will be asked for their thoughts towards these treatments individually.
Secondary Outcomes
No secondary outcomes reported