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Effects of Tiotropium/Olodaterol on Cardio-pulmonary Exercise Capacity in Patients With Hyperinflated Chronic Obstructive Pulmonary Disease [ACHIEVE]

NCT04994574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-04-07

No results posted yet for this study

Summary

\[Background\] Hyperinflation caused by increased airflow limitation and emphysema change commonly accompanies dyspnea, which leads to inactivity, reducing exercise capacity, and deconditioning. Hyperinflation in COPD is also associated with decreased left and right end-diastolic volume and stroke volume, and cardiac output.

Previous studies investigated effects of ICS/LABA or LABA/LAMA versus placebo on cardiac function in patients with COPD and lung hyperinflation. However, there are not evidences for effects of LABA/LAMA on cardio-pulmonary exercise capacity.

Cardiopulmonary exercise testing (CPET) is an exercise stress test with concomitant expired gas analysis, which provides objective parameters of functional capacity. Since CPET can assess integrated exercise responses of cardiopulmonary, vascular, and skeletomuscular systems, it can reveal abnormalities that are not apparent in a resting state. Moreover, change in oxygen consumption during exercise and anaerobic threshold can be evaluated.

The investigators would like to investigate change in cardio-pulmonary exercise capacity via CPET before and after tiotropium/olodaterol inhalation in COPD patients with hyperinflation, which is the first clinical study. Association between change in cardio-pulmonary exercise capacity with function of heart and lung would be further evaluated with cardiac magnetic resonance (CMR) and lung function.

The in investigators expect to enhance cardio-pulmonary exercise capacity though the improvement in cardiac and pulmonary function with tiotropium/olodaterol inhalation. This result would provide evidence to encourage to treat with dual bronchodilators in COPD patients with hyperinflation.

\[Study objectives\] To investigate and compare the bronchodilator effect of tiotropium/olodaterol on cardio-pulmonary exercise capacity in hyperinflated COPD patients

\[Study design\] Prospective, single-center, one-arm clinical study After using the tiotropium/olodaterol inhaler for 4weeks, the investigators will compare pre- and post- cardio-pulmonary exercise capacity, cardiac function, lung function, symptoms and quality of life

\[Statistic methods\] For continuous variables, data will be presented as median, minimum, maximum with standard deviation (95% confidence intervals). For categorical variables, data will be presented as percentage (95% confidence intervals). Paired t-test for continuous variables and chi-squared test for categorical variables will be performed to compare the difference in results before and after inhalation of the tiotropium/olodaterol inhaler.

This is a pilot study; therefore, sample size cannot be calculated by power analysis, because of the absence of any data in the literature that could be reviewed. A sample size is expected to be 40 patients. When the drop-out rate 10% is considered, final sample size is expected to be 44.

Conditions

Interventions

DRUG

tiotropium/olodaterol

From Visit 2(Baseline), test subjects will be use tiotropium/olodaterol inhaler once a day for 4 weeks. After that, visit the hospital at 4 weeks to receive examination and terminate participation.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Ji Ye Jung · Severance Hospital, Yonsei University Health System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2024-07-25
Completion
2024-07-25

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04994574 on ClinicalTrials.gov