Recruiting

Triple Therapy vs. Dual Bronchodilators: Impact on Air Trapping and Inflammation in COPD

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to compare the effects of triple therapy versus dual bronchodilators on air trapping and inflammation in individuals with COPD, specifically focusing on changes in lung volume.

What is being tested

Trelegy or Anoro

Drug
Who is being recruted

Chronic Disease+5

+ Lung Diseases

+ Lung Diseases, Obstructive

From 40 to 80 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorMahidol University
Study Contactkittipong maneechotesuwan, MD, PhD.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on people with Chronic Obstructive Pulmonary Disease, commonly known as COPD, which affects breathing. It aims to compare the effects of two different treatments: one involves a combination of three medications, Fluticasone Furoate, Vilanterol, and Umeclidinium (triple therapy), and the other uses just two, Vilanterol and Umeclidinium (dual bronchodilators). The goal is to see how these treatments help with reducing air getting trapped in the lungs and also how they affect substances in the body that are linked to inflammation. This is important because managing air trapping and inflammation can significantly improve breathing and quality of life for those with COPD. Participants in the study will receive the treatments, which are typically administered through inhalation. The study will observe how well each treatment works by measuring the amount of air trapped in the lungs and examining levels of inflammatory substances in both the airways and blood. By comparing these results, researchers hope to identify which treatment is more effective in managing symptoms of COPD. The study is in Phase 3, which means it is focused on confirming the effectiveness of these treatments in a larger group of people. There are no specific risks or benefits mentioned, but generally, such studies aim to establish treatments that are both effective and safe.

Official TitleThe Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
NCT06474039
Principal SponsorMahidol University
Study Contactkittipong maneechotesuwan, MD, PhD.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

3 inclusion criteria required to participate
Patients who have met the criteria for COPD GOLD B defined by an exacerbation not more than 1 time in the last year prior to the study enrollment. These patients will be recruited in sequential sequence.

Patients with COPD GOLD B are previously treated with either LAMA or LAMA/LABA or short-acting bronchodilators

Patients who are able to provide informed consent.

4 exclusion criteria prevent from participating
Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung, other malignancy, active heart diseases.

Receiving long-term treatment with immunosuppressive drugs and systemic corticosteroids

Being treated with triple therapy (ICS/LABA/LAMA)

Being in terminally ill conditions

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Phase 1

Group II

Experimental
Phase 2

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Division of Respiratory Disease and TB, Siriraj Hospital

Bangkoknoi, ThailandOpen Division of Respiratory Disease and TB, Siriraj Hospital in Google Maps
Recruiting
One Study Center