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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01533922
Other study ID # 1237.13
Secondary ID 2011-004659-37
Status Completed
Phase Phase 3
First received February 13, 2012
Last updated August 12, 2015
Start date March 2012
Est. completion date November 2013

Study information

Verified date August 2015
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Human Research Ethics CommitteeAustria: Austrian Medicines and Medical Devices AgencyBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCanada: Health CanadaChile: Instituto de Salud Pública de ChileGermany: Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteeNew Zealand: MedsafeUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
placebo matching tiotropium + olodaterol FDC
Tiotropium
Tiotropium 5 mcg once daily
Olodaterol
Olodaterol 5 mcg once daily
tiotropium + olodaterol
tiotropium + olodaterol 5 mcg once daily
Tiotropium + Olodaterol
Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily
Device:
Respimat
Respimat inhaler

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Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Chile,  Germany,  Italy,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap 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.
6 weeks No
Primary Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap 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.
6 weeks No
Secondary Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity 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.
6 weeks No
Secondary Forced Expiratory Volume in 1 Second (One Hour Post-dose) Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose)
The presented means are adjusted means from MMRM model.
6 weeks No
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