Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study
Launched by THAMMASAT UNIVERSITY · Mar 28, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to see how well two different combinations of inhaled medications work for people with Chronic Obstructive Pulmonary Disease (COPD), specifically focusing on a condition called small airway disease. The two treatments being compared are Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV). Researchers want to find out if BGF is just as effective as FUV in helping patients breathe better and if there are any side effects from either treatment.
To participate in this study, individuals should be between 40 and 80 years old, have been diagnosed with COPD, and have a history of smoking. They should also have specific lung function test results that confirm their condition. Participants will undergo tests to measure their lung function and may be asked to report any health issues they experience while using the inhalers. This trial aims to help improve treatment options for people living with COPD.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC \< 70%)
- • Aged 40-80 years
- • Smoking 10 pack-years or more
- • Postbronchodilator FEV1 \< 80%
- Exclusion Criteria:
- • History of COPD exacerbation within 3 months
- • Asthma, bronchiectasis, pulmonary fibrosis
- • Inability to perform spirometry, impulse oscillometry, or 6-minute walk test
- • Pregnant or breastfeeding women
About Thammasat University
Thammasat University, a leading academic institution in Thailand, is dedicated to advancing medical research and education through its various faculties and research centers. With a commitment to fostering innovative healthcare solutions, the university sponsors clinical trials aimed at enhancing patient outcomes and addressing pressing health challenges. Leveraging a multidisciplinary approach, Thammasat University collaborates with healthcare professionals and researchers to ensure rigorous scientific methodologies and ethical standards are upheld in all its clinical research endeavors. Through these initiatives, the university seeks to contribute significantly to the global body of medical knowledge and improve public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pathumthani, , Thailand
Patients applied
Trial Officials
Narongkorn Saiphoklang, MD
Principal Investigator
Thammasat University Faculty of Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported