Clinical trial NCT03221192: Qualitative Analysis of Subject Experience of Nasal Polyps
Official title: Qualitative Research to Characterize the Patient Experience of Nasal Polyps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Polyps
Keywords: Real-time data capture
Concept elicitation
Nasal polyps
Cognitive debriefing
Patient-reported outcomes
HRQoL
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty adult subjects in the US, and 10 adult subjects in Germany with severe, recurrent nasal polyps who have undergone nasal polyp surgery in the past 10 years prior to screening will be included in this study.

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants Who Reported Primary Symptoms
timeFrame: Up to 120 minutes
measure: Number of Participants Who Reported Secondary Symptoms
timeFrame: Up to 120 minutes
measure: Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms
timeFrame: Up to 120 minutes
measure: Number of Participants Reporting Proximal Impacts-Physical Impact
timeFrame: Up to 120 minutes
measure: Number of Participants Reporting Proximal Impacts-Sleep Impact
timeFrame: Up to 120 minutes
measure: Number of Participants Reporting Proximal Impacts-ADL Impact
timeFrame: Up to 120 minutes
measure: Number of Participants Reporting Distal Impacts-emotional Impact
timeFrame: Up to 120 minutes
measure: Number of Participants Reporting Distal Impacts-social Impact
timeFrame: Up to 120 minutes
measure: Number of Participants Reporting Distal Impacts-work/School Impact
timeFrame: Up to 120 minutes
measure: Number of Participants Reporting Distal Impacts-treatment Impact
timeFrame: Up to 120 minutes
measure: Number of Participants Who Reported Symptoms to be Targeted by New Treatment
timeFrame: Up to 120 minutes
measure: Number of Participant Who Reported Impacts to be Targeted by New Treatment
timeFrame: Up to 120 minutes
measure: Number of Participants Reporting Factors to be Considered for Surgery
timeFrame: Up to 120 minutes
measure: Number of Participants With Ease of Decision to Have Surgery
timeFrame: Up to 120 minutes
measure: Number of Participants Who Reported on the Positive or Negative Impacts of Surgery
timeFrame: Up to 120 minutes
measure: Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment
timeFrame: Up to 120 minutes
measure: Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition
timeFrame: Up to 120 minutes
measure: Number of Participants Who Liked or Disliked VAS Assessments
timeFrame: Up to 120 minutes
measure: Number of Participants With Difficulties Completing VAS Assessments
timeFrame: Up to 120 minutes
measure: Number of Participants Who Understood VAS Anchors
timeFrame: Up to 120 minutes
measure: Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22
timeFrame: Up to 120 minutes
measure: Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition
timeFrame: Up to 120 minutes
measure: Number of Participants Who Liked or Disliked SNOT-22 Assessments
timeFrame: Up to 120 minutes
measure: Number of Participants With Difficulties Completing SNOT-22
timeFrame: Up to 120 minutes
measure: Number of Participants Who Understood SNOT-22 Response Options
timeFrame: Up to 120 minutes
measure: Number of Participants Who Reported Missing SNOT-22 Items
timeFrame: Up to 120 minutes
Secondary outcomes:
measure: Number of Participants Reporting Symptom Variability-Application (App) Task
timeFrame: Up to 10 days
measure: Number of Participants Reporting Primary Symptoms as Identified During App Task
timeFrame: Up to 10 days
measure: Number of Participants Reporting Secondary Symptoms as Identified During App Task
timeFrame: Up to 10 days
measure: Number of Participants Reporting Physical Impacts as Idenfied During the App Task
timeFrame: Up to 10 days
measure: Number of Participants Reporting Sleep Impacts as Identified During the App Task
timeFrame: Up to 10 days
measure: Number of Participants Reporting ADL Impacts as Identified During the App Task
timeFrame: Up to 10 days
measure: Number of Participants Reporting Emotional Impacts as Identified During the App Task
timeFrame: Up to 10 days
measure: Number of Participants Reporting Social Functioning Impacts as Identified During the App Task
timeFrame: Up to 10 days
measure: Number of Participants Reporting Work Impacts as Identified During the App Task
timeFrame: Up to 10 days
measure: Number of Participants Reporting Treatment Impacts as Identified During the App Task
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hall R, Trennery C, Chan R, Gater A, Bradley H, Sikirica MV, von Maltzahn R, Sousa AR, Nelsen LM. Understanding the Patient Experience of Severe, Recurrent, Bilateral Nasal Polyps: A Qualitative Interview Study in the United States and Germany. Value Health. 2020 May;23(5):632-641. doi: 10.1016/j.jval.2019.11.005. Epub 2020 Mar 11.