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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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

olodaterol

tiotropium

Placebo

tiotropium

olodaterol

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
Patients must have a diagnosis of COPD and must meet the following spirometric criteria:

Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1>30% and < 80% of predicted normal (ECSC, GOLD II - III) and a post-bronchodilator FEV1/FVC <70% at Visit 1

Male or female patients, 40 years of age or older.
Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
Patients who have never smoked cigarettes must be excluded.
Patients must be able to perform technically acceptable pulmonary function tests according to ATS/ERS guidelines and maintain records in a paper diary
Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).

Exclusion criteria:

Significant disease other than COPD
Clinically relevant abnormal lab values.
History of asthma.
Diagnosis of thyrotoxicosis
Diagnosis of paroxysmal tachycardia
History of myocardial infarction within 1 year of screening visit
Unstable or life-threatening cardiac arrhythmia
Hospitalization for heart failure within the past year
Known active tuberculosis
Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
History of life-threatening pulmonary obstruction and patients with chronic respiratory failure
History of cystic fibrosis
Clinically evident bronchiectasis
History of significant alcohol or drug abuse
Thoracotomy with pulmonary resection
Patients treated with oral or patch ß-adrenergics
Patients treated with oral corticosteroid medication at unstable doses or at doses in excess of 10mg prednisolone per day or equivalent
Regular use of daytime oxygen therapy for more than one hour per day
Pulmonary rehabilitation program in the six weeks prior to the screening visit or patients currently in a pulmonary rehabilitation program
Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Known hypersensitivity to ß-adrenergic and/or anticholinergic drugs, BAC, EDTA
Pregnant or nursing women
Women of childbearing potential not using a highly effective method of birth control
Patient who have previously been randomized in this study or are currently participating in another study
Patients who are unable to comply with pulmonary medication restrictions prior to randomization

Sites / Locations

1237.7.49004 Boehringer Ingelheim Investigational Site
1237.7.49005 Boehringer Ingelheim Investigational Site
1237.7.49007 Boehringer Ingelheim Investigational Site
1237.7.49002 Boehringer Ingelheim Investigational Site
1237.7.49003 Boehringer Ingelheim Investigational Site
1237.7.49001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Tiotropium/Olodaterol FDC

Tiotropium and Olodaterol FC

Placebo

Arm Description

patient will receive tiotropium and olodaterol in a fixed dose combination

patient will receive tiotropium and olodaterol in a free combination

patient will receive placebo

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration

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

Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points

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

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

Mean heart rate 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

Peak 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

Heart rate 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

Mean RR 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

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

RR 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

Mean QT 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

Peak QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)

QT Change From Patient Baseline at Individual Post-dose Time Points

QT change from patient baseline at individual post-dose time points

Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points

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

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)

QTcB Change From Patient Baseline at Individual Post-dose Time Points

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

Mean PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)

Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points

Peak PR 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

PR change from patient baseline at individual post-dose time points

Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points

Mean QRS 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

Peak QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)

QRS Change From Patient Baseline at Individual Post-dose Time Points

QRS change from patient baseline at individual post-dose time points

Full Information

NCT ID

NCT02030535

First Posted

January 7, 2014

Last Updated

June 19, 2015

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02030535

Brief Title

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

Official Title

A Randomised, Placebo-controlled, Double-blind, Single Dose, Cross-over Study to Evaluate the Efficacy and Safety of Orally Inhaled Tiotropium + Olodaterol as Both a Fixed Dose Combination and a Free Combination (Both Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tiotropium/Olodaterol FDC

Arm Type

Experimental

Arm Description

patient will receive tiotropium and olodaterol in a fixed dose combination

Arm Title

Tiotropium and Olodaterol FC

Arm Type

Experimental

Arm Description

patient will receive tiotropium and olodaterol in a free combination

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

patient will receive placebo

Intervention Type

Drug

Intervention Name(s)

olodaterol

Intervention Description

free combination with tiotropium

Intervention Type

Drug

Intervention Name(s)

tiotropium

Intervention Description

free combination with olodaterol

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

tiotropium

Intervention Description

fixed dose combination with olodaterol

Intervention Type

Drug

Intervention Name(s)

olodaterol

Intervention Description

fixed dose combination with tiotropium

Primary Outcome Measure Information:

Title

Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration

Description

Time Frame

1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose

Secondary Outcome Measure Information:

Title

Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points

Description

Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)

Time Frame