Last updated: 08/12/2021 08:00:08
Qualitative analysis of subject experience of nasal polyps
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Qualitative research to characterize the patient experience of nasal polyps
Trial description: 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 purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with nasal polyps participating in CE interviews
Timeframe: 1 day
Generation of subject feedback regarding the adequacy of Sino-Nasal Outcomes Test (SNOT-22) tool
Timeframe: 1 day
Generation of subject feedback regarding the adequacy of GSK visual analogue scales (VAS) tool assessment
Timeframe: 1 day
Secondary outcomes:
Identification of important concepts related to nasal polyps though CE interviews
Timeframe: 1 day
Evaluation of the existing PRO instruments via questionnaires
Timeframe: 1 day
Analysis of 'real time' experience of nasal-polyps by using real time data capture app
Timeframe: Up to 10 days
Interventions:
Enrollment:
27
Primary completion date:
2018-28-02
Observational study model:
Cohort
Time perspective:
Cross-Sectional
Clinical publications:
Hall R, Trennery C, Chan R, Gater A, Bradley H, Sikirica MV, von Maltzahn R, Sousa AR, Nelsen L.Understanding the patient experience of severe, recurrent, bilateral nasal polyps: a qualitative interview study in the United States and Germany .Value Health.2020;23(5):632-641
DOI: 10.1016/j.jval.2019.11.005
PMID: 32389229
Medical condition
Nasal Polyps
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
July 2017 to February 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Subject has a clinical diagnosis of bilateral nasal polyps as diagnosed by endoscopy or CT scan.
- Subject is aged 18 or over.
- Subject has a diagnosis of cystic fibrosis.
- Subject has a diagnosis of eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young’s, Kartagener’s or dyskinetic ciliary syndromes).
Inclusion and exclusion criteria
Inclusion criteria:
- Subject has a clinical diagnosis of bilateral nasal polyps as diagnosed by endoscopy or CT scan.
- Subject is aged 18 or over.
- Subject has severe nasal polyps symptoms defined as a subject-reported nasal obstruction VAS score of >5.
- Subject had at least one previous surgery in the past ten years for the removal of nasal polyps. Surgery in this case is defined as any procedure involving instruments with resulting incision and removal of polyp tissue from the nasal cavity (polypectomy).
- Subject is currently an eligible candidate for polypectomy defined by an overall subject-reported VAS symptom score of >7 and an endoscopic bilateral nasal polyp score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
- Subject has symptoms consistent with chronic rhinosinusitis.
- Subject is currently receiving intranasal corticosteroids for the management of their nasal polyps.
- Subject is willing to participate in the study and provide informed consent.
- Subject is an English speaker and is able to read, write and fully understand the English language.
- Subject is willing to and able to attend and participate in a 90-minute interview to discuss their experiences of nasal polyps and obtain their feedback on several symptom/impact questionnaires. For real-time data capture:
- Subject owns/or has access to either a smartphone [iPhone Operating System (iOS) or android] or tablet which has video, audio/microphone and photographic capabilities and access to either the Apple app store or Google play store to download the app.
- Subject is willing and able to take part in the real-time data application task and respond to a series of questions/tasks fielded to them via the application over the course of 10 days and is willing to respond to some brief questions following the real-time data capture task about their experience of using the app and completing the tasks, either during their interview or in a 5-10 minute telephone call following completion of the task.
- Subject would feel comfortable recording short videos of themselves and providing audio commentary in response to questions/tasks.
Exclusion criteria:
- Subject has a diagnosis of cystic fibrosis.
- Subject has a diagnosis of eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young’s, Kartagener’s or dyskinetic ciliary syndromes).
- Subject has a diagnosis of antrochoanal polyps.
- Subject has a diagnosis of nasal septal deviation occluding one nostril.
- Subject has had acute sinusitis or upper respiratory tract infection in the last two week.
- Subject has ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis).
- Subject has had an asthma exacerbation requiring admission to hospital in the last four weeks.
- Subject is currently or has previously taken part in a clinical trial for nasal polyps.
- Subject is unwilling or unable to comply with the requirements of the study or has a physical or mental condition or learning difficulties that, in the opinion of the physician, may affect the subject’s ability to participate in the study, the responses he/she might provide or their ability to provide consent.
Trial location(s)
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02210
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2018-28-02
Actual study completion date
2018-28-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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