Skip to main content
OpenTrials
Completed

NCT Number: NCT02030535

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1237.7.49004 Boehringer Ingelheim Investigational Site, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olodaterol

Drug

free combination with tiotropium

Tiotropium

Drug

free combination with olodaterol

Placebo

Drug

Primary outcomes

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

    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

    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 outcomes

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

    Time frame: 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)

  2. Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points

    Time frame: 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)

  3. Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points

    Time frame: 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)

  4. Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points

    Time frame: 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)

  5. Heart Rate Change From Patient Baseline at Individual Post-dose Time Points

    Time frame: 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

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

    Time frame: 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)

  7. Peak RR Change From Patient Baseline Over All Post-dose Time Points

    Time frame: 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)

  8. RR Change From Patient Baseline at Individual Post-dose Time Points

    Time frame: 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

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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

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

    Time frame: 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)

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

    Time frame: 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)

  17. PR Change From Patient Baseline at Individual Post-dose Time Points

    Time frame: 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

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 8, 2014
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.