The ECFS-CTN cannot guarantee that the information provided here is comprehensive. Please go to the ClinicalTrials.gov link for detailed and up-to-date information on study background, eligibility criteria, study design, outcome measures, study status, participating sites, sponsor contact information and timelines.
You can also contact the CTN coordinating centre for additional information: ECFS-CTN@uzleuven.be (link sends e-mail)
| Study Name on ClinicalTrials.gov (link is external) | Tiotropium Bromide in Cystic Fibrosis |
|---|---|
| Study Drug | Tiotropium Respimat® inhaler |
| Type of Study Drug | Bronchodilator |
| Study Title | A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis. |
| Study Phase | 3 |
| Study Sponsor | Boehringer Ingelheim Pharmaceuticals |
http://clinicaltrials.gov/ct2/show/NCT01179347 (link is external) | |
| Participating ECFS-CTN sites | Belgium: Leuven |
| Age | Adults and Pediatrics |
Study results
Boehringer Tiotropium Phase 3 study results
The Phase 3 trial (NCT01179347) "A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 ?g administered once daily via the Respimat® device in patients with cystic fibrosis" was conducted in 99 sites across 20 countries.
Four hundred and sixty-three patients (298 were 12 years or older and 165 younger than 12 years) were enrolled to investigate the efficacy and long-term safety of tiotropium solution for inhalation. Three hundred and eight patients received tiotropium solution (5 ?g delivered by the Respimat® inhaler once daily) and 105 subjects received placebo during the 12-week study.
The results showed that lung function as measured by FEV1 (forced expiratory volume in 1 second), in participants old enough to do lung function, was slightly better in patients receiving tiotropium as compared with those receiving the placebo inhaler. However, the difference in lung function was only very slight and did not reach statistical significance. No difference was observed between the tiotropium and placebo group in terms of Quality of Life questionnaire results or the rates of pulmonary exacerbations.
Safety profile was good in all age groups, with no concerning side effects seen in any participant, although there was slightly more cough seen in those receiving tiotropium. There were no abnormalities seen on blood testing of any participant and no significant change in electrocardiogram.
12 ECFS-CTN sites in Belgium, France, Germany, Italy, Portugal and UK participated in this study and enrolled 94 of the 463 patients.
The summary of data provided here is from a sponsor synopsis of results.