Phase 3
Completed N=184
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
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02629965 ↗
Enrolled (actual)
184
Serious AEs
3.9%
Results posted
Jun 2019
Primary outcomePrimary: Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose — 1.875; 1.990 Litre (L) — p=<0.001
◆ Published Evidence
Established
24citations · ~3 / year
Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO<sup>®</sup> study.
Summary
This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.
Linked Publications
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Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO<sup>®</sup> study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose |
1.875; 1.990 | <0.001 sig |
| SECONDARY 6-minute Walk Distance [Meter] |
307.356; 311.524 | 0.4291 |
| SECONDARY Average Number of Step Per Day (Step/Day) |
3550.400; 3559.901 | 0.9098 |
| SECONDARY Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs) |
10.206; 9.914 | 0.5338 |
| SECONDARY Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs) |
44.662; 45.601 | 0.3524 |
| SECONDARY Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs) |
171.935; 174.192 | 0.3949 |
| SECONDARY Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs |
148.647; 151.067 | 0.4955 |
| SECONDARY 60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre) |
2.962; 3.096 | <0.0001 sig |
| SECONDARY 30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre) |
1.169; 1.275 | <0.0001 sig |
| SECONDARY 30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre) |
2.857; 3.020 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
- All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator Forced expiratory volume in one second (FEV1) = 40 years.
- 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 with score on the modified Medical Research Council (mMRC) >= 1.
- Patients who walk = 4 at the end of 6 minute walk test (6MWT) at Visit 2.
- Patients must be able to perform technically acceptable pulmonary function tests (spirometry), to use the physical activity monitor and must be able to complete 6MWT during the study period as required in the protocol.
- Patients must be able to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler.
Exclusion criteria
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may put the patient at risk because of participation in the study, influence the results of the study and cause concern regarding the patient's ability to participate in the study.
- Patients with clinically relevant abnormal baseline haematology, blood chemistry,urinalysis or creatinine > x2 upper limit of normal (ULN) will be excluded regardless of clinical condition (a repeat laboratory evaluation can be conducted if deemed necessary by the investigator).
- Patients with a current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02629965) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.