Qualitative Research to Explore Treatment Preference in Pulmonary Arterial Hypertension (PAH) Subjects

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hypertension, Pulmonary

Treatments: Other: Telephone concept elicitation interview

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03304548

207754

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

All subjects with PAH

Description:

A total of 8 to 10 US-English speaking PAH subjects will be recruited. They will take part in a 30-minute telephone concept elicitation interview. All interviews will be audio-recorded and transcribed verbatim.

Treatment:

Other: Telephone concept elicitation interview