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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

NCT06474039 · Mahidol University
In plain English

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About this study
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
Eligibility criteria
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 design
Enrollment target: 50 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-10-01
Estimated completion: 2026-12
Last updated: 2025-05-06
Interventions
Drug: Trelegy or Anoro
Primary outcomes
  • Changes in lung volume (4 weeks)
Sponsor
Mahidol University · other
Contacts & investigators
Contactkittipong maneechotesuwan, MD, PhD. · contact · kittipong.man@mahidol.ac.th · 0894996858
InvestigatorKittipong Maneechotesuwan, MD,PhD · principal_investigator, Siriraj Hospital
All locations (1)
Division of Respiratory Disease and TB, Siriraj HospitalRecruiting
Bangkoknoi, BKK, Thailand
The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD · TrialPath