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Chronic Obstructive Pulmonary DiseaseNCT04994574

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

A study testing tiotropium/olodaterol in people with Chronic Obstructive Pulmonary Disease, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

[Background] Hyperinflation caused by increased airflow limitation and emphysema change commonly accompanies dyspnea, which leads to inactivity, reducing exercise capacity, and deconditioning. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
tiotropium/olodaterol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSouth Korea
Study dates
23 Aug 2021to 25 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The person who voluntarily signed the consent form
  • Adults over 40 years of age
  • Patients who diagnosed with COPD
  • Patients with smoking history of 10 packs or more
  • Patients who are taking or in need of tiotropium/olodaterol inhaler for the treatment of COPD
  • Patients in a clinically stable state within 3 months of screening
Show all 9Show fewer
  • Patients who confirmed FEV1/FVC < 0.7 and FEV1 <80% after using bronchodilator
  • Patients who confirmed FRC > 125%
  • Patients who confirmed mMRC > 2

Who cannot join

  • Patients with a history of asthma
  • Patients with asthma- COPD overlap
  • Patients with serious disease other than COPD
  • Patients with unstable or life-threatening cardiac arrhythmias
  • Patients hospitalized for heart failure or myocardial infarction within 1 year of screening
  • Patients with systolic ejection fraction less than 40%
Show all 9Show fewer
  • Patients with unstable ischemic heart disease
  • Patients receiving regular oxygen therapy for 1hour or more per day
  • Others who are difficult to participate in the research under judgment of the investigation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital, Yonsei University Health System

    Seoul

Other trials in South Korea

About this study

[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.

Read more

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.

Being tested
tiotropium/olodaterol
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tiotropium/olodaterolDrug

    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.

Study groups in NCT04994574
Study groupRoleWhat they receive
tiotropium/olodaterolExperimentalNot described
Receives: Drug: tiotropium/olodaterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of maximum oxygen consumption

    After 4 weeks of tiotropium/olodaterol inhaler use, measure the change in the maximum oxygen consumption (VO2, ml/kg/min) during the cardio-pulmonary exercise test compared to the baseline

    Measured: At 4 weeks

Secondary outcomes (9)

  1. Change in cardiopulmonary exercise test results after 4 weeks compared to baseline

    After 4 weeks of tiotropium/olodaterol inhaler use, measure the secondary outcomes during the cardio-pulmonary exercise test compared to the baseline

    Measured: At 4 weeks

  2. Change in cardiac MRI results after 4 weeks compared to baseline

    After 4 weeks of tiotropium/olodaterol inhaler use, measure the secondary outcomes during the cardiac MR compared to the baseline

    Measured: At 4 weeks

  3. Change in echocardiography results after 4 weeks compared to baseline

    After 4 weeks of tiotropium/olodaterol inhaler use, measure the secondary outcomes during the echocardiography compared to the baseline

    Measured: At 4 weeks

  4. Change in spirometry results after 4 weeks compared to baseline

    After 4 weeks of tiotropium/olodaterol inhaler use, measure the secondary outcomes during pulmonary function test compared to the baseline

    Measured: At 4 weeks

  5. Change in questionnaire evaluation and quality of life (CAT score) after 4 weeks compared to baseline

    < Questionnaire >

    COPD Assessment Test(CAT) score : from 0 to 40, the higher scores denote a more severe impact of COPD on patient's life

    Measured: At 4 weeks

  6. Change in questionnaire evaluation and quality of life (mMRC score) after 4 weeks compared to baseline

    < Questionnaire >

    Modified Medical Research Council(mMRC) scale : from 0 to 4, the higher scale, the more deterioration in severity of dyspnea

    Measured: At 4 weeks

  7. Change in questionnaire evaluation and quality of life (BDI score) after 4 weeks compared to baseline

    < Questionnaire >

    Baseline Dyspnea Index(BDI score : from 0 to 12, the lower the score, the more deterioration in severity of dyspnea

    Measured: At 4 weeks

  8. Change in questionnaire evaluation and quality of life (TDI score) after 4 weeks compared to baseline

    < Questionnaire >

    Transitional Dyspnea Index(TDI) score : from -9 to +9, the lower the score, the more deterioration in severity of dyspnea

    Measured: At 4 weeks

  9. Change in serologic cardiac biomarkers after 4 weeks compared to baseline

    < Serologic cardiac biomarker>

    NTproBNP, high sensitive troponin, soluble ST2

    Measured: At 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start23 Aug 2021
  3. Primary completion25 Jul 2024
  4. Study completion25 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04994574
Sponsor's protocol ID
4-2021-0635
Status last verified
Apr 2026
First submitted
12 Jul 2021
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cazzola M, Rogliani P, Matera MG. Cardiovascular disease in patients with COPD. Lancet Respir Med. 2015 Aug;3(8):593-5. doi: 10.1016/S2213-2600(15)00279-9. Epub 2015 Jul 22. No abstract available.

    PubMed 26208993

  • de Miguel Diez J, Chancafe Morgan J, Jimenez Garcia R. The association between COPD and heart failure risk: a review. Int J Chron Obstruct Pulmon Dis. 2013;8:305-12. doi: 10.2147/COPD.S31236. Epub 2013 Jun 28.

    PubMed 23847414

  • Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.

    PubMed 21115606

  • Labaki WW, Xia M, Murray S, Curtis JL, Barr RG, Bhatt SP, Bleecker ER, Hansel NN, Cooper CB, Dransfield MT, Wells JM, Hoffman EA, Kanner RE, Paine R 3rd, Ortega VE, Peters SP, Krishnan JA, Bowler RP, Couper DJ, Woodruff PG, Martinez FJ, Martinez CH, Han MK. NT-proBNP in stable COPD and future exacerbation risk: Analysis of the SPIROMICS cohort. Respir Med. 2018 Jul;140:87-93. doi: 10.1016/j.rmed.2018.06.005. Epub 2018 Jun 5.

    PubMed 29957287

  • Ledwidge M, Gallagher J, Conlon C, Tallon E, O'Connell E, Dawkins I, Watson C, O'Hanlon R, Bermingham M, Patle A, Badabhagni MR, Murtagh G, Voon V, Tilson L, Barry M, McDonald L, Maurer B, McDonald K. Natriuretic peptide-based screening and collaborative care for heart failure: the STOP-HF randomized trial. JAMA. 2013 Jul 3;310(1):66-74. doi: 10.1001/jama.2013.7588.

    PubMed 23821090

  • Ledwidge MT, O'Connell E, Gallagher J, Tilson L, James S, Voon V, Bermingham M, Tallon E, Watson C, O'Hanlon R, Barry M, McDonald K. Cost-effectiveness of natriuretic peptide-based screening and collaborative care: a report from the STOP-HF (St Vincent's Screening TO Prevent Heart Failure) study. Eur J Heart Fail. 2015 Jul;17(7):672-9. doi: 10.1002/ejhf.286.

    PubMed 26139583

Questions about this trial

What is this clinical trial studying?

A study testing tiotropium/olodaterol in people with Chronic Obstructive Pulmonary Disease, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of maximum oxygen consumption (time frame: At 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04994574, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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