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
NCT02030535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2015-07-16
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
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- DRUG
-
olodaterol
free combination with tiotropium
- DRUG
-
tiotropium
free combination with olodaterol
- DRUG
- DRUG
-
tiotropium
fixed dose combination with olodaterol
- DRUG
-
olodaterol
fixed dose combination with tiotropium
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2014-06-30
- Completion
- 2014-06-30
Countries
- Germany
Study Locations
More Related Trials
-
Efficacy and Safety of Free Combination of Tiotropium + Formoterol Compared to Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02238119 ·Status: COMPLETED ·Phase: PHASE2
-
To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways
NCT02085161 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD
NCT00530842 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.
NCT01703845 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD
NCT00239460 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease
NCT05295355 ·Status: UNKNOWN ·Phase: NA
-
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
NCT02006732 ·Status: COMPLETED ·Phase: PHASE3
-
Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients
NCT02629965 ·Status: COMPLETED ·Phase: PHASE3
-
Free Combinations of Tiotropium Inhalation Powder Capsule + Salmeterol Metered Dose Inhaler, Tiotropium Inhalation Powder Capsule and Salmeterol Metered Dose Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02242253 ·Status: COMPLETED ·Phase: PHASE2
-
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy
NCT04184297 ·Status: COMPLETED
-
Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients
NCT02969317 ·Status: COMPLETED ·Phase: PHASE1
-
Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
NCT01431287 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Dual Bronchodilator Treatment on Cardiopulmonary Interactions in COPD
NCT03425617 ·Status: COMPLETED ·Phase: PHASE4
-
Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
NCT01431274 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD
NCT00535366 ·Status: COMPLETED ·Phase: PHASE2
-
Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
NCT01964352 ·Status: COMPLETED ·Phase: PHASE3
-
12-week Treatment With Inhaled Tiotropium (18 mcg Once Daily) on Lung Function and Static Lung Volumes in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients. Correlation to Dyspnoea Scales
NCT02172378 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
NCT01040728 ·Status: COMPLETED ·Phase: PHASE3
-
Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease
NCT01559116 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01372410 ·Status: COMPLETED ·Phase: PHASE2
-
Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
NCT01969721 ·Status: COMPLETED ·Phase: PHASE3
-
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
NCT00239473 ·Status: COMPLETED ·Phase: PHASE3
-
A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler
NCT03663569 ·Status: COMPLETED
-
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
NCT01040689 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Tiotropium/Olodaterol on Cardio-pulmonary Exercise Capacity in Patients With Hyperinflated Chronic Obstructive Pulmonary Disease [ACHIEVE]
NCT04994574 ·Status: COMPLETED ·Phase: NA