A Double-blind, Randomised Study to Assess the Influence of Tiotropium (Spiriva®)

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00257452
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To demonstrate that tiotropium (Spiriva®) does not prolong the QT interval of the ECG more than placebo

Detailed Description

The objective of this study is to demonstrate that tiotropium does not prolong the QT interval more than placebo. This will be achieved by testing non-inferiority hypothesis.

Study Hypothesis:

There is one primary variable to be tested for non-inferiority: tiotropium high dose compared to placebo:

H0: µ(TIO,12) - µ(PBO,12) \>= 10 ms vs. H1: µ(TIO,12) - µ(PBO,12) \< 10 ms where µ(TIO,12), µ(PBO,12) represent the mean change from baseline QTcF between 5 minutes and 2 hours after 12 days of treatment (taking the mean of the time-matched differences between baseline and post-baseline values in each treatment period) with tiotropium 54 µg, or placebo, respectively.

If the data suggest that the Fridericia correction is poor for the study population, an alternative correction will be explored (QTcN). The other correction formula would be used as a replacement for the Fridericia correction and would be defined before unblinding of the data.

Comparison(s):

Placebo, moxifloxacin as active control

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-11-21
• Study First Submitted QC: 2005-11-21
• Study First Posted: 2005-11-23
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mean change from baseline of the corresponding QTcF values of all ECGs taken from 5 minutes to 2 hours after dosing	Day 12

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline of the corresponding QTcF values of all ECGs taken from 5 minutes to 24 hours after dosing	Day 1 and 12
Difference (tiotropium minus placebo) between the maximal time-matched change from baseline of the QTcF values of all ECGs taken from 0:05 - 23:50 after dosing	Day 1 and 12
Mean change from baseline of the corresponding QTcF values of all ECGs taken from 5 minutes to 2 hours after dosing	Day 1

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum; 🇩🇪 Ingelheim/Rhein, Germany