A prospective single-arm study on the efficacy and safety of short-course oral corticosteroids followed by topical corticosteroids in patients with severe chronic rhinosinusitis with nasal polyps

ABSTRACT

Background

Little evidence exists regarding an integrated multidimensional evaluation methodology to analyze the within-patient effects of medical treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). We aimed to use an integrated evaluation model to analyze the effects of short-course oral corticosteroid (OCS) followed by intranasal corticosteroid spray (INCS) therapy in patients with severe CRSwNP.

Methods

In all, 32 patients with severe CRSwNP received oral methylprednisolone for three weeks followed by intranasal budesonide spray for nine weeks in this prospective single-arm study. An evaluation model integrating the concepts of the core outcome set (COS), clinical control and minimum clinically important difference (MCID) was longitudinally evaluated.

Results

All uncontrolled patients at baseline showed similar progressive improvements from baseline and more than 1 MCID response across core outcomes during the OCS period, with severe CRSwNP being partly controlled in 31 (96.9%) patients and uncontrolled in 1 (3.1%) patient at 3 weeks. During the subsequent INCS period, 14 (43.8%) patients gradually deteriorated to an uncontrolled status at 12 weeks, whereas 18 (56.2%) exhibited partly controlled CRSwNP until 12 weeks.

Conclusions

In more than half of the patients, severe CRSwNP was partly controlled with the initial OCS followed by INCS therapy. An integrated evaluation model was used to facilitate the comprehensive evaluation of within-patient response, especially in patients with different responses to the same treatment.

Trial registration

ChiCTR1900024287.

KEYWORDS:

• Chronic rhinosinusitis
• glucocorticoids
• minimal clinically important difference
• nasal polyps
• outcome measures

Declaration of interest

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Author contributions

L Zhand and X Wang provided administrative support to the study; X Wang, S Shao, N Zhang and C Bachert contributed to the study concept and design; X Wang, S Shao, Y Wang, Y Zhao, Y Sima, Y Xu, and T Wang assisted with acquisition, analysis, and interpretation of data; all the other authors contributed to manuscript preparation and review; all authors reviewed and provided direction for manuscript development and provided critical feedback and final approval for publication.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics approval and consent to participate

The study was approved by the Ethics Committee of Beijing TongRen Hospital (TRECKY2019–050). Written informed consent was obtained from all participants prior to enrollment.

Additional information

Funding

This work was supported by the National Key R&D Program of China (2016YFC0905200); the program for the Changjiang scholars and innovative research team (IRT 13082); the National Natural Science Foundation of China (81970852, 82000962 and 82171110); the Beijing Natural Science Foundation (7222024); the CAMS Innovation Fund for Medical Sciences (2019-I2M-5-022); the Beijing Municipal Science & Technology Commission (Z211100002921057) ; the Capital’s Funds for Health Improvement and Research (2022-1-1091); the Beijing Bai-Qian-Wan talent project (2019A32); the Interdisciplinary cooperation project of Beijing Science and Technology Star (20220484226); the Public Welfare Development and Reform Pilot Project (2019-10); the National Science and Technology Major Project (2019ZX09201-005) and the High Level Public Health Technical Talent Training Plan (Lingjunrencai-01-08, Lingjunrencai-02-09).