Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03221192
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2017-07-05
Brief Title:
Qualitative Analysis of Subject Experience of Nasal Polyps
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Qualitative Research to Characterize the Patient Experience of Nasal Polyps
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nasal polyposis is a chronic inflammatory disease of the nose and sinuses GlaxoSmithKline GSK is embarking on a clinical program to assess treatment of severe recurrent nasal polyps with an anti-interleukin-5 anti-IL5 mepolizumab Subject specific symptomatic endpoints will form the basis for the assessment of treatment benefit of nasal polyp therapies However there is a lack of published qualitative data regarding nasal polyps to understand the symptoms or health-related quality of life HRQoL impacts This cross-sectional qualitative study aims to address this unmet gap by conducting semi-structured combined concept elicitation CE and cognitive debriefing CD telephone interviews and real-time data capture The combined CE and CD interviews each 90 minutes in duration will investigate the subject experience of nasal polyps and the relevance and understanding of existing patient-reported outcomes PRO instruments The real-time data capture conducted over a 10 day period will investigate the subject experience of the symptoms HRQoL impacts and treatment of nasal polyps and any day-to-day variability that exists in these experiences in real time Twenty adult subjects in the United States US and 10 adult subjects in Germany with severe recurrent nasal polyps will participate in the CE and CD interviews section of the study and of these 10 subjects from US will also complete real-time data capture app task
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None