Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Placebo; Drug: olodaterol; Drug: tiotropium

• Registration Number: NCT02030535
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Disposition First Submitted: 2014-06-25
• Disposition First Submitted QC: 2014-06-25
• Disposition First Posted: 2014-06-26
• Status Verified: 2015-06
• Results First Submitted: 2015-06-19
• Results First Submitted QC: 2015-06-19
• Last Update Submitted: 2015-06-19
• Results First Posted: 2015-07-16
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	patient will receive placebo
Tiotropium and Olodaterol FC	olodaterol	patient will receive tiotropium and olodaterol in a free combination
Tiotropium/Olodaterol FDC	tiotropium	patient will receive tiotropium and olodaterol in a fixed dose combination
Tiotropium/Olodaterol FDC	olodaterol	patient will receive tiotropium and olodaterol in a fixed dose combination
Tiotropium and Olodaterol FC	tiotropium	patient will receive tiotropium and olodaterol in a free combination

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration	1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose	The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)).; For patients who did not complete all periods, patient baseline was the average of the available period baselines.; The means presented are the adjusted means.

Secondary Outcome Measures

Name	Time	Method
Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Peak PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Mean QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Peak QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Mean heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Heart Rate Change From Patient Baseline at Individual Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Heart rate change from patient baseline at individual post-dose time points
Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Mean QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Peak heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Peak RR Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Peak RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
RR Change From Patient Baseline at Individual Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	RR change from patient baseline at individual post-dose time points
QT Change From Patient Baseline at Individual Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	QT change from patient baseline at individual post-dose time points
QRS Change From Patient Baseline at Individual Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	QRS change from patient baseline at individual post-dose time points
Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Mean RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
QTcB Change From Patient Baseline at Individual Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	QTcB change from patient baseline at individual post-dose time points
Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Mean PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Peak QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Peak QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
PR Change From Patient Baseline at Individual Post-dose Time Points	40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose	PR change from patient baseline at individual post-dose time points

Trial Locations

Locations (6)

1237.7.49004 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

1237.7.49007 Boehringer Ingelheim Investigational Site; 🇩🇪 Frankfurt, Germany

1237.7.49005 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

1237.7.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Weinheim, Germany

1237.7.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Großhansdorf, Germany

1237.7.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 Hamburg, Germany