OBJECTIVES: Chronic rhinosinusitis (CRS) causes chronic inflammation of the nose and paranasal sinuses, with nasal polyps (CRSwNP) or without (CRSsNP). This work documents (1) key disease-related symptoms and impacts that individuals living with CRSwNP and CRSsNP experience, (2) outcomes that are important to consider when developing new treatments, and (3) clinical outcome assessments (COAs) available to measure those outcomes.

METHODS: Independent though related literature and clinical trial/product label reviews were conducted to identify symptoms and impacts associated with CRSwNP and CRSsNP among adults and adolescents as well as COAs used to assess the concepts in clinical trials. The identified CRSwNP and CRSsNP concepts were mapped to concepts assessed by selected COAs.

RESULTS: A total of 39 CRSwNP (n=20 articles) and CRSsNP-related (n=12 articles) symptoms and 49 impacts were identified in the literature. For both conditions, altered smell (n=20 and 12, respectively), nasal obstruction (n=19 and 11, respectively), and discharge (n=18 and 11, respectively) were symptoms most frequently reported. For CRSwNP, facial pain (n=17) and fatigue (n=13) were also frequently reported. The most frequently reported impacts for both conditions were on emotional functioning and sleep. Fifteen COAs (e.g., Sino-nasal Outcome Test [SNOT-22]) were evaluated for conceptual coverage of concepts identified in the literature.

CONCLUSIONS: Though limited information is available for adolescent groups, individuals with CRSwNP and CRSsNP experience similar, though not always the same, symptoms with altered smell, nasal discharge, nasal obstruction, facial pain, and fatigue principal among them. Given the many life-limiting impacts these symptoms exert on patients, particularly emotionally and on sleep, results from this research specify several symptom and impact outcomes, that if improved, would reflect benefit for patients living with these conditions. Several of the reviewed COAs demonstrated adequate conceptual coverage of the conditions and warrant further evaluation for use in clinical trials to support efficacy analysis.