Qualitative Analysis of Subject Experience of Nasal Polyps

NCT ID: NCT03221192

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2018-02-28

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.

Conditions

Nasal Polyps

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Subjects participating in CE and CD interviews

Twenty adult subjects from the US and 10 adult subjects from Germany with severe recurrent nasal polyps who have received nasal polyp surgery in the past 10 years prior to screening will be asked to participate in CE and CD interviews

VAS questionnaire

Intervention Type: OTHER

VAS questionnaire is a PRO tool in which subjects will be asked to evaluate overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 centimeter (cm) or 100 millimeter (mm) whereby 0 represents 'no symptom' and '10 or 100 represents 'as bad as you can imagine', Scores of 0-3 (or 0-30) are defined as mild disease, \>3-7 (or \>30-70) as moderate disease and \>7-10 (or \>70-100) as severe disease.

SNOT-22 questionnaire

Intervention Type: OTHER

SNOT-22 is a PRO tool to measure HRQoL associated with rhinosinusitis with or without nasal polyps. It contains 22 nose, sinus, and general HRQoL items and subjects will be required to score the experience on a 6-point scale ranging from 0 (no problem) to 5 (Problem as bad as it can be) and identify the five most important items affecting their health.

Subjects participating in interview and real-time data capture

Ten subjects from the US with severe recurrent nasal polyps who are participating in CE and CD interviews will be asked to complete the real-time data capture app task.

VAS questionnaire

Intervention Type: OTHER

VAS questionnaire is a PRO tool in which subjects will be asked to evaluate overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 centimeter (cm) or 100 millimeter (mm) whereby 0 represents 'no symptom' and '10 or 100 represents 'as bad as you can imagine', Scores of 0-3 (or 0-30) are defined as mild disease, \>3-7 (or \>30-70) as moderate disease and \>7-10 (or \>70-100) as severe disease.

SNOT-22 questionnaire

Intervention Type: OTHER

SNOT-22 is a PRO tool to measure HRQoL associated with rhinosinusitis with or without nasal polyps. It contains 22 nose, sinus, and general HRQoL items and subjects will be required to score the experience on a 6-point scale ranging from 0 (no problem) to 5 (Problem as bad as it can be) and identify the five most important items affecting their health.

Data capture app

Intervention Type: OTHER

Real time data capture app is a smart-phone or web-based application which will allow the subjects to communicate about their experience of nasal polyps in real-time as they go about their daily lives via varying video, audio, photographic and text responses.

Interventions

VAS questionnaire

VAS questionnaire is a PRO tool in which subjects will be asked to evaluate overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 centimeter (cm) or 100 millimeter (mm) whereby 0 represents 'no symptom' and '10 or 100 represents 'as bad as you can imagine', Scores of 0-3 (or 0-30) are defined as mild disease, \>3-7 (or \>30-70) as moderate disease and \>7-10 (or \>70-100) as severe disease.

Intervention Type: OTHER

SNOT-22 questionnaire

SNOT-22 is a PRO tool to measure HRQoL associated with rhinosinusitis with or without nasal polyps. It contains 22 nose, sinus, and general HRQoL items and subjects will be required to score the experience on a 6-point scale ranging from 0 (no problem) to 5 (Problem as bad as it can be) and identify the five most important items affecting their health.

Intervention Type: OTHER

Data capture app

Real time data capture app is a smart-phone or web-based application which will allow the subjects to communicate about their experience of nasal polyps in real-time as they go about their daily lives via varying video, audio, photographic and text responses.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Boston, Massachusetts, United States

Countries

United States

References

Gater A, Tolley C, Williams-Hall R, Trennery C, Bradley H, Sikirica MV, Nelsen L, Sousa AR, Bratton DJ, Chan R, von Maltzahn R. Patient-Reported Outcome Measures for Severe Recurrent Bilateral Nasal Polyps: Psychometric Evaluation and Content Validity. OTO Open. 2023 Dec 21;7(4):e84. doi: 10.1002/oto2.84. eCollection 2023 Oct-Dec.

Reference Type: DERIVED

PMID: 38130916 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32389229 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

206325

Identifier Type: -

Identifier Source: org_study_id