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Clinical Trials/NCT06474039
NCT06474039RecruitingPhase 3

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

Mahidol University1 site in 1 country50 target enrollmentStarted: October 1, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
50
Locations
1
Primary Endpoint
Changes in lung volume
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Treatment 1

Experimental

Phase 1

Intervention: Trelegy or Anoro (Drug)

Treatment 2

Experimental

Phase 2

Intervention: Trelegy or Anoro (Drug)

Outcomes

Primary Outcomes

Changes in lung volume

Time Frame: 4 weeks

TLC, RV, RV/TLC, IOS

Secondary Outcomes

  • Inflammatory cytokines(4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kittipong Maneechotesuwan

Professor Dr.

Mahidol University

Study Sites (1)

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