The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
Phase 3
Not yet recruiting
- Conditions
- COPD
- Interventions
- Drug: Trelegy or Anoro
- Registration Number
- NCT06474039
- Lead Sponsor
- Mahidol University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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.
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment 1 Trelegy or Anoro Phase 1 Treatment 2 Trelegy or Anoro Phase 2
- Primary Outcome Measures
Name Time Method Changes in lung volume 4 weeks TLC, RV, RV/TLC, IOS
- Secondary Outcome Measures
Name Time Method Inflammatory cytokines 4 weeks FENO, hs-CRP, sputum cell counts and differential counts