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

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).

Official Title
-----------------
Qualitative Research to Explore Patient Preference for Modes of Administration in Pulmonary Arterial Hypertension Treatments

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Other: Telephone concept elicitation interview


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All subjects with PAH<br>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. | Other: Telephone concept elicitation interview<br>* All interview questions are designed to be very open-ended in order to ascertain subjects' preferences in an un-biased manner (as possible), with additional probes only being used when necessary to ensure all concepts of interest are covered. Subjects will be asked a series of broad, open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of taking oral treatment(s) for their PAH.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who preferred subcutaneous injection versus current treatment options | 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. | Up to 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAH, Telephone interviews, Subcutaneous, Low-interventional, Qualitative research