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NCT03221192 · ClinicalTrials.gov registry record
Qualitative Analysis of Subject Experience of Nasal Polyps
A clinical trial of Nasal Polyps, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 27
- Enrollment target
- 1
- Study location
NCT03221192: Completed study of Nasal Polyps, sponsored by GlaxoSmithKline.
NCT03221192 is a study of Nasal Polyps that has completed, run by GlaxoSmithKline. The registered enrollment target is 27 participants, below the 99-participant average among 7 other Nasal Polyps trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03221192, a study of Nasal Polyps, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 27 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
During the CE section of the interview, participants were asked a series of broad open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of having nasal polyps. In addition, participants were asked more focused questions designed to probe on issues that they may not have mentioned during the course of the interview spontaneously or concepts/statements that required additional clarification. The interviews were transcribed/translated
Conditions Studied
Interventions
- OTHER VAS questionnaire
- OTHER SNOT-22 questionnaire
- OTHER Data capture app
Study Locations (1)
Massachusetts
- GSK Investigational Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2018-02-28 |
What the finished NCT03221192 record still lists
NCT03221192 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 99-participant average among 7 other Nasal Polyps trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Nasal Polyps appearing as the primary indexed condition, and to 3 interventions - of which VAS questionnaire is the first listed.
NCT03221192 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03221192 about?
NCT03221192 is a clinical study titled "Qualitative Analysis of Subject Experience of Nasal Polyps". 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 fo...
What is the current status of trial NCT03221192?
This trial is currently completed. The enrollment target is 27 participants. The study started on 2017-07-31. Estimated completion is 2018-02-28.
What conditions does trial NCT03221192 study?
This clinical trial studies the following conditions: Nasal Polyps.
What interventions are being tested in trial NCT03221192?
The interventions under investigation include: VAS questionnaire (OTHER), SNOT-22 questionnaire (OTHER), Data capture app (OTHER).
Who is sponsoring clinical trial NCT03221192?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03221192 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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