Abstract: AIM: To investigate the characteristics of clinical trials of inhalation in pediatric population in China. METHODS: The pediatric clinical trials of inhaled drugs in China registered on the www.Chinadrugtrials.org.cn and Clinical Trials in USA respectively until November 20, 2021 were reviewed. The characteristics of pediatric clinical trials of inhaled drugs including the clinical trial phases, drug indications and classificatio etc. were analyzed. RESULTS: There were 21 pediatric clinical trials of inhaled drugs registered on the www.Chinadrugtrials.org.cn, accounted for 8.9%(21/235) of inhalation clinical trials in all populations. 47.6% of them were generic drugs, mainly focusing on expectorants for Phlegm symptoms and inhaled preparations for asthma, which accounting for 71.4%(15/21) . There were 34 pediatric clinical trials of inhaled drugs registered on the Clinical Trials in USA, the drug indications of which were mainly asthma and anesthesia, accounting for 76.5%(26/34). CONCLUSION: The pediatric clinical trials of inhalations in China started later, and the total number is small compared to adults, mainly focusing on generic drugs. We should pay attention to the research and development of new inhalation drugs, standardizing and promoting the clinical trials of inhaled drugs in pediatric population actively.

Key words: inhaled drugs, pediatric, clinical trials