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

Mahidol University

Status and phase: Enrolling; Phase 3

Conditions: COPD

Treatments: Drug: Trelegy or Anoro

Study type: Interventional

Funder types: Other

Identifiers

NCT06474039

Si344/2024

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Treatment 1

Experimental group

Description:

Phase 1

Treatment:

Drug: Trelegy or Anoro

Treatment 2

Experimental group

Description:

Phase 2

Treatment:

Drug: Trelegy or Anoro