Status:

RECRUITING

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

Lead Sponsor:

Thammasat University

Conditions:

COPD

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility:

All Genders

40-80 years

Phase:

PHASE4

Brief Summary

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 treatin...

Detailed Description

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 on...

Eligibility Criteria

Inclusion

  • COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC \< 70%)
  • Aged 40-80 years
  • Smoking 10 pack-years or more
  • Postbronchodilator FEV1 \< 80%

Exclusion

  • 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

Key Trial Info

Start Date :

April 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2026

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT06905483

Start Date

April 1 2025

End Date

March 31 2026

Last Update

April 29 2025

Active Locations (1)

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Narongkorn Saiphoklang

Pathum Thani, Changwat Pathum Thani, Thailand, 12120