Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium + Olodaterol; Drug: Placebo; Drug: Tiotropium; Drug: Olodaterol; Device: Respimat

• Registration Number: NCT01533922
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-16
• Study Start: 2012-03
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Disposition First Submitted: 2014-04-30
• Disposition First Submitted QC: 2014-04-30
• Disposition First Posted: 2014-05-16
• Results First Submitted: 2015-06-19
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-12
• Last Update Submitted: 2015-08-12
• Results First Posted: 2015-09-15
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tiotropium + olodaterol High dose QD	Tiotropium + Olodaterol	patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
Tiotropium + olodaterol High dose QD	Respimat	patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
Tiotropium + olodaterol Low dose QD	Tiotropium + Olodaterol	patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
Tiotropium + olodaterol Low dose QD	Respimat	patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
Tiotropium 5 mcg QD	Respimat	patient will receive tiotropium 5 mcg once daily
Olodaterol 5 mcg QD	Respimat	patient will receive olodaterol 5 mcg once daily
Placebo QD	Placebo	-
Placebo QD	Respimat	-
Tiotropium 5 mcg QD	Tiotropium	patient will receive tiotropium 5 mcg once daily
Olodaterol 5 mcg QD	Olodaterol	patient will receive olodaterol 5 mcg once daily

Primary Outcome Measures

Name	Time	Method
Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap	6 weeks	Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap).; Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.; The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model.
Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap	6 weeks	Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap).; Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.; The presented means are adjusted mean from the MMRM model.

Secondary Outcome Measures

Name	Time	Method
Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity	6 weeks	Slope of the intensity of breathing discomfort during Constant Work Rate Cycle Ergometry (CWRCE) to symptom limitation at 75% Work capacity (Wcap). The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal).; Slope of breathing discomfort is defined as: (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time.; A decrease in slope indicates improvement.; The presented means are adjusted means from MMRM model.
Forced Expiratory Volume in 1 Second (One Hour Post-dose)	6 weeks	Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose); The presented means are adjusted means from MMRM model.

Trial Locations

Locations (44)

1237.13.01302 Boehringer Ingelheim Investigational Site; 🇺🇸 Torrance, California, United States

1237.13.01308 Boehringer Ingelheim Investigational Site; 🇺🇸 Hartford, Connecticut, United States

1237.13.01304 Boehringer Ingelheim Investigational Site; 🇺🇸 Livonia, Michigan, United States

1237.13.01307 Boehringer Ingelheim Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States

1237.13.01305 Boehringer Ingelheim Investigational Site; 🇺🇸 Easley, South Carolina, United States

1237.13.01301 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenville, South Carolina, United States

1237.13.01303 Boehringer Ingelheim Investigational Site; 🇺🇸 Spartanburg, South Carolina, United States

1237.13.01306 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States

1237.13.54301 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1237.13.54302 Boehringer Ingelheim Investigational Site; 🇦🇷 Mar del Plata, Argentina

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