Recruiting NCT06474039
The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trelegy or Anoro.
- Who it may be relevant to
- Registry conditions: COPD. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug Trelegy or Anoro
Both drugs delivered via Ellipta device and blinded package appearance
Primary outcome measures
- Changes in lung volume [Time frame: 4 weeks]
Secondary outcome measures (1)
- Inflammatory cytokines [Time frame: 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Division of Respiratory Disease and TB, Siriraj Hospital — Bangkoknoi
Identifiers
NCT: NCT06474039 · Si344/2024