Narongkorn Saiphoklang
Pathum Thani, Changwat Pathum Thani, 12120, Thailand
NCT Number: NCT06905483
The goal of this clinical trial is to determine if triple inhaled therapy with Budesonide/Glycopyrronium/Formoterol (BGF) and Fluticasone Furoate/Umeclidinium/Vilanterol (FUV) are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.
The main questions it aims to answer are:
* Does BGF demonstrate a comparable effect to FUV in COPD participants? * What medical problems do participants experience when taking BGFand FUV?
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Notify Me40 year–80 year
All sexes
Interventional
Phase 4
Pathum Thani, Changwat Pathum Thani, 12120, Thailand
This study is a randomized crossover study. COPD patients aged 40 years or older with stable disease are included. Each patient receives four weeks of treatment with either BGF or FUV followed by a one-week washout period, and then four weeks of treatment with the other drug. Respiratory symptoms are assessed using modified Medical Research Council (mMRC) dyspnea scale and COPD Assessment Test (CAT). Pulmonary function is assessed by spirometry with bronchodilator testing, and adverse events were recorded. Spirometry data, including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced expiratory flow at 25-75% of FVC (FEF25-75) are also collected. Impulse oscillometry (IOS) is also performed, with results reported as R5, R20, R5-R20, X5, Fres, and Ax.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each patient received 4 weeks of treatment with either BGF or FUV followed by a 1-week washout period, and then 4 weeks of treatment with the other drug.
Other names: Breztri
Each patient received 4 weeks of treatment with either BGF or FUV followed by a 1-week washout period, and then 4 weeks of treatment with the other drug.
Other names: Trelegy
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in R5 assessed by impulse oscillometry (IOS), reported as kPa/L/s and percent predicted value.
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in R20 assessed by impulse oscillometry (IOS), reported as kPa/L/s and percent predicted value.
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in R5-R20 assessed by impulse oscillometry (IOS), reported as kPa/L/s.
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in X5 assessed by impulse oscillometry (IOS), reported as kPa/L/s.
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in FEV1 assessed by spirometry, reported as liter (L) and percent predicted value.
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in FVC assessed by spirometry, reported as liter (L) and percent predicted value.
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in FEV1/FVC ratio assessed by spirometry, reported as percent.
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in FEF25-75 assessed by spirometry, reported as liter/second (L/s) and percent predicted value.
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in this dyspnea scale are reported in points, with a minimum range of 0 and a maximum of 5. Higher scores indicate more symptoms.
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in this score are reported in points, with a minimum range of 0 and a maximum of 40. Higher scores indicate more symptoms.
Thammasat University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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