Comparing two inhaled therapies for COPD treatment
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
This study is testing two different inhalers to see which one works better and is safer for people with stable COPD.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Thammasat University Academic / other |
| Locations | 1 site (Pathumthani) |
| Trial ID | NCT06905483 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of two triple inhaled therapies, Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV), in patients with stable chronic obstructive pulmonary disease (COPD). It employs a randomized crossover design where participants will receive each treatment for four weeks, separated by a one-week washout period. The study will assess respiratory symptoms and pulmonary function using various tests, including spirometry and impulse oscillometry. Adverse events will also be monitored throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are COPD patients aged 40 to 80 years with a confirmed diagnosis and stable condition.
Not a fit: Patients with a history of COPD exacerbation within the last three months or those with other respiratory conditions like asthma or pulmonary fibrosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with COPD, potentially improving their lung function and quality of life.
How similar studies have performed: Other studies have shown promising results with similar inhaled therapies for COPD, indicating that this approach is well-supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pathumthani
- Narongkorn Saiphoklang — Pathumthani, Thailand (Recruiting)
Study contacts
- Principal investigator: Narongkorn Saiphoklang, MD — Thammasat University Faculty of Medicine
- Study coordinator: Narongkorn Saiphoklang, MD
- Email: M_narongkorn@hotmail.com
- Phone: +6629269794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.