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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06474039
Enrollment
50
Registered
2024-06-25
Start date
2024-10-01
Completion date
2026-12-31
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

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

Interventions

DRUGTrelegy or Anoro

Both drugs delivered via Ellipta device and blinded package appearance

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in lung volume4 weeksTLC, RV, RV/TLC, IOS

Secondary

MeasureTime frameDescription
Inflammatory cytokines4 weeksFENO, hs-CRP, sputum cell counts and differential counts

Countries

Thailand

Contacts

Primary Contactkittipong maneechotesuwan, MD, PhD.
kittipong.man@mahidol.ac.th0894996858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026