Analysis of Clinical Trials of Nasal Sprays Registration in China in the Past 10 Years
10.13748/j.cnki.issn1007-7693.20231900
- VernacularTitle:中国鼻用喷雾剂注册临床试验近10年现状分析
- Author:
ZHANG Wanjin
1
;
WANG Qian
2
;
LI Gang
1
;
ZHANG Jingchen
3
Author Information
1. Shanghai Center for Drug Evaluation and Inspection, Shanghai 201210, China
2. Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring, Shanghai 200040, China
3. Yangtze River Delta Center for Drug Evaluation and Inspection of NMPA, Shanghai 201210, China
- Publication Type:Journal Article
- Keywords:
nasal sprays;
clinical trials;
registration and information disclosure platform
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(20):2860-2864
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To analyze the current situation and characteristics of clinical trials of nasal spray registration in China in the past 10 years, and to discuss the future development trend of nasal spray drugs in China, taking into account the current situation of international research. METHODS By accessing the State Drug Administration's drug clinical trial registration and information disclosure platform(http://www.chinadrugtrials.org.cn/index.html), collected information on clinical trials of nasal spray drugs in China from the open registration date(November 1, 2012) to March 29, 2023, in terms of clinical trial status, analyzed the status and characteristics of clinical trials of nasal sprays in terms of clinical trial status, indications, geographical distribution and trial phases, and trial design types by Microsoft Office Excel. RESULTS A total of 80 clinical trials of nasal sprays were conducted in China, of which 24 (30.0%) were phase I, 15 (18.8%) were phase II, 13(16.3%) were phase III, 3(3.8%) were phase IV, 17(21.3%) were bioequivalence trials, and 8(10.0%) were other(pharmacokinetic/pharmacodynamic studies). The status of clinical trials included 13(16.3%) in progress(not yet enrolled), 7(8.8%) in progress (enrollment completed), 15(18.8%) in progress (enrollment in progress), 44(55.0%) completed, and 1(1.3%) voluntarily terminated. There were 56 phase I-IV clinical trials, including 41(73.2%) parallel group trials, 14(25.0%) crossover design trials, and 1(1.8%) single-arm trial. A total of 65(81.3%) were chemicals, 7(8.8%) were biologics and 8(10.0%) were traditional Chinese medicine/natural drugs. A total of 15 indications were identified, which included allergic rhinitis, sedation, dry eye, paroxysmal supraventricular tachycardia, etc. CONCLUSION The research and development of nasal sprays in China is still at an early stage, but it keeps up with the international and independent innovation ability is being strengthened, and more new clinical research directions and strategies of nasal sprays should be explored in the future to help the development of nasal sprays and meet the needs of more patients.
