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

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Other: Telephone concept elicitation interview

• Registration Number: NCT03304548
• Lead Sponsor: GlaxoSmithKline

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-09
• Study Start: 2017-11-22
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects with PAH	Telephone concept elicitation interview	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.

Primary Outcome Measures

Name	Time	Method
Number of subjects who preferred subcutaneous injection versus current treatment options	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Boston, Massachusetts, United States