Trial reportAdvances in therapy2025
Peak Nasal Inspiratory Flow and the Association with Nasal Obstruction in Patients with Severe CRSwNP from the SINUS-24/-52 Studies.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNasal congestion/obstruction (NC) contributes to the high disease burden in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). Patient perception of NC may not accurately reflect nasal patency, while peak nasal inspiratory flow (PNIF) is an objective method with established thresholds for normal nasal airflow. This analysis evaluated the association between NC and PNIF and the impact of baseline PNIF on dupilumab efficacy in patients with severe CRSwNP.
methodsThis was a post hoc analysis of patients treated with placebo or dupilumab 300 mg every 2 weeks in the SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) phase III studies. Patients provided daily e-diary measures of PNIF (L/min) using PNIF meters, and NC by patient-reported evaluation of severity (scored 0-3). Other assessed outcomes were nasal polyp score (NPS), 22-item Sinonasal Outcome Test (SNOT-22), loss of smell (LoS), University of Pennsylvania Smell Identification Test (UPSIT), and Lund-Mackay computed tomography. Outcomes were assessed in two subgroups: baseline PNIF < 120 L/min and ≥ 120 L/min.
resultsOf 724 patients, 552 (76%) had PNIF < 120 L/min and 172 (24%) had PNIF ≥ 120 L/min at baseline. The PNIF < 120 L/min subgroup had higher mean scores for NPS and SNOT-22 and more smell impairment (LoS and UPSIT). PNIF weakly correlated with NC at baseline (Spearman coefficient - 0.348 [95% CI - 0.410, - 0.282], P < 0.0001). Correlations between change from baseline in PNIF and NC at week 24 were weak in the dupilumab group (- 0.390 [- 0.468, - 0.305], P < 0.0001) and moderate in the placebo group (- 0.497 [- 0.582, - 0.399], P < 0.0001).
conclusionThese results confirm PNIF as a valuable method for assessing nasal obstruction in patients with severe CRSwNP. The degree of nasal flow impairment at baseline does not impact dupilumab's efficacy. A graphical abstract and video abstract are available for this article.
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