Long-term tiotropium bromide therapy was retrospectively analyzed in adults with cystic fibrosis

Objective: The chronic and life-limiting pulmonary disease caused by cystic fibrosis is often treated with bronchodilators. We investigated, for the first time, the effect of 24 months long-term tiotropium bromide therapy in people with cystic fibrosis on pulmonary lung function and risk of exacerbation. Methods: In this retrospective cohort study, we compare 24 months of tiotropium bromide therapy with a non-tiotropium bromide treated control group. Data was obtained from local patient registry (MUKO.doc). Forty-nine patients with 18 µg once-daily inhaled tiotropium bromide therapy were selected. Forty-nine non-tiotropium bromide treated control patients were identified and matched by gender, age and forced expiratory volume in 1 second at the beginning of 24 month observation period (FEV10M). The primary end point was the mean annual change of FEV1. The secondary end point included measures of exacerbation. Results: The study included 172 patients, divided into tiotropium bromide treated (n=86) and non-tiotropium bromide treated control patients (n=86). Patients treated with tiotropium bromide showed a significant difference of mean annual change of FEV1 (control: -2.2±5.18 %; treated: -0.43±4.4 %). But tiotropium bromide therapy was not associated with a lower exacerbation risk. Mean annual change of number of exacerbations was not significant reduced in tiotropium bromide treated patients. Tiotropium bromide was well tolerated in all studied patients. Conclusion: In patients with cystic fibrosis, long-term therapy with tiotropium bromide was associated with a significant effect on mean annual change in FEV1 but not with exacerbation risk.