The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD

This study aims to demonstrate the effects of triple therapy (ICS/LABA/LAMA) and dual bronchodilators (LAMA/LABA) on air trapping in the lungs' COPD patients and inflammatory mediators

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Drug: Trelegy or Anoro

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: kittipong maneechotesuwan, MD, PhD.; Phone Number: 0894996858; Email: kittipong.man@mahidol.ac.th

Study Locations

• Thailand
  • BKK
    • Bangkoknoi, BKK, Thailand, 10700
      • Recruiting
      • Division of Respiratory Disease and TB, Siriraj Hospital
      • Contact: Kittipong - Maneechotesuwan, MD., PhD.; Phone Number: 15 06624197757; Email: sikmn@mahidol.ac.th
      • Contact: Adisak - Wongkajornsilp, MD., Ph.D.; Phone Number: 06624198573; Email: siawj@mahidol.ac.th
      • Principal Investigator: Kittipong Maneechotesuwan, MD., PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment 1; Phase 1	Drug: Trelegy or Anoro; Both drugs delivered via Ellipta device and blinded package appearance
Experimental: Treatment 2; Phase 2	Drug: Trelegy or Anoro; Both drugs delivered via Ellipta device and blinded package appearance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lung volume	TLC, RV, RV/TLC, IOS	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory cytokines	FENO, hs-CRP, sputum cell counts and differential counts	4 weeks

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Kittipong Maneechotesuwan, MD,PhD, Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Si344/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No