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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

NCT ID: NCT06474039

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment 1

Phase 1

Group Type EXPERIMENTAL

Trelegy or Anoro

Intervention Type DRUG

Both drugs delivered via Ellipta device and blinded package appearance

Treatment 2

Phase 2

Group Type EXPERIMENTAL

Trelegy or Anoro

Intervention Type DRUG

Both drugs delivered via Ellipta device and blinded package appearance

Interventions

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Trelegy or Anoro

Both drugs delivered via Ellipta device and blinded package appearance

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Kittipong Maneechotesuwan

Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kittipong Maneechotesuwan, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Division of Respiratory Disease and TB, Siriraj Hospital

Bangkoknoi, BKK, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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kittipong maneechotesuwan, MD, PhD.

Role: CONTACT

[email protected]
0894996858

Facility Contacts

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Kittipong - Maneechotesuwan, MD., PhD.

Role: primary

[email protected]
06624197757 ext. 15

Adisak - Wongkajornsilp, MD., Ph.D.

Role: backup

[email protected]
06624198573

Other Identifiers

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Si344/2024

Identifier Type: -

Identifier Source: org_study_id

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