Tiotropium bromide for cystic fibrosis

作者：Bin Hasan Saadoun; Ratjen Felix^*

来源：Expert Opinion on Orphan Drugs, 2015, 3(8): 957-966.

DOI：10.1517/21678707.2015.1065728

• anticholinergic
• bronchodilator
• clinical trials
• cystic fibrosis
• tiotropium bromide

Introduction: Airway obstruction is a common feature in cystic fibrosis (CF) patients and bronchodilators, either short or long acting, are widely used in CF care.
Areas covered: Tiotropium bromide is a long-acting anticholinergic muscarinic receptor antagonist, leading to bronchodilation and to a lesser extent reduction of airway secretions. Its once daily use has shown to be beneficial in other chronic lung diseases such as chronic obstructive pulmonary disease (COPD). This review summarizes the current evidence of tiotropium bromide in CF.
Expert opinion: None of the current bronchodilator studies reflect a complete drug development program with tiotropium being the first to complete Phase I to III studies with adequate number of patients. Whereas the Phase II trial showed positive effects on lung function, this was not confirmed in the Phase III trial. The predefined pooled analysis of both studies provided evidence for benefit especially in patients treated with long-acting beta 2 agonists (LABAs) potentially reflecting concomitant asthma. No benefits in other outcome measures such as pulmonary exacerbation were seen in these trials. Thus, the data suggest that tiotropium has some effect on bronchomotor tone, but the effect size was small and clinical benefits could not be demonstrated.

• 出版日期2015