Triple Therapy vs. Dual Bronchodilators: Impact on Air Trapping and Inflammation in COPD
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.
Trelegy or Anoro
Chronic Disease+5
+ Lung Diseases
+ Lung Diseases, Obstructive
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy 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
Division of Respiratory Disease and TB, Siriraj Hospital
Bangkoknoi, ThailandOpen Division of Respiratory Disease and TB, Siriraj Hospital in Google Maps