6.2.2 Phase II clinical trials Based on positive Phase I results, researchers initiated the Phase II clinical trial named Airleaf (NCT05238675) in March 2022 ( Besides the Airleaf study, the research team also initiated two additional Phase II clinical trials, Clairafly (NCT05865886) and Clairleaf (NCT05846230) ( The Clairafly trial focuses on evaluating BI 1291583s safety, tolerability, pharmacodynamics, and pharmacokinetics in adult patients with cystic fibrosis-related bronchiectasis ( The Clairleaf study represents a long-term safety and efficacy evaluation study specifically designed for bronchiectasis patients who previously participated in Airleaf or Clairafly trials ( 6.2.3 Future development plans Additionally, the Phase III randomized, double-blind, placebo-controlled clinical trial named AIRTIVITY (NCT06872892) is planned to commence in June 2025 ( 6.3 HSK31858 clinical studies 6.3.1 Study design and population HSK31858 has completed Phase II clinical studies (SAVE-BE) in Chinese bronchiectasis patients (Zhong et al., 2025)
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