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Search / Trial NCT06905483

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

Copd Chronic Obstructive Pulmonary Disease Small Airway Disease Triple Inhaled Therapy Budesonide/Glycopyrronium/Formoterol Fluticasone Furoate/Umeclidinium/Vilanterol

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.

Locations

Pathumthani, , Thailand

Patients applied

0 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