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NCT Number: NCT06474039

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

Recruiting

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Respiratory Disease and TB, Siriraj Hospital

Bangkoknoi, BKK, 10700, Thailand

Location status: Recruiting

Location contact

Adisak - Wongkajornsilp, MD., Ph.D.

CONTACT

[email protected]

06624198573

Kittipong - Maneechotesuwan, MD., PhD.

CONTACT

[email protected]

06624197757 ext. 15

Kittipong Maneechotesuwan, MD., PhD.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trelegy or Anoro

Drug

Both drugs delivered via Ellipta device and blinded package appearance

Primary outcomes

  1. Changes in lung volume

    Time frame: 4 weeks

    TLC, RV, RV/TLC, IOS

Secondary outcomes

  1. Inflammatory cytokines

    Time frame: 4 weeks

    FENO, hs-CRP, sputum cell counts and differential counts

Study contacts

Contact information is provided by the study sponsor or research team.

kittipong maneechotesuwan, MD, PhD.

CONTACT

[email protected]

0894996858

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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