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NCT07541378Felfüggesztve

Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD

Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD: Randomised Crossover Study (COMPETE)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.

Megadott ok: Recruitment was temporarily suspended pending additional funding and activation of additional study centers. The pilot phase has been completed and is currently being evaluated. The suspension was not related to safety concerns.

Rövid összefoglaló (regiszter, angolul)

This study is designed to directly compare the effects of widely available long-acting bronchodilator therapies in patients with chronic obstructive pulmonary disease (COPD). The trial evaluates three fixed-dose combinations of a long-acting beta-2 agonist and a long-acting muscarinic antagonist (LABA/uLAMA)-umeclidinium/vilanterol (Anoro® Ellipta), indacaterol/glycopyrronium (Ultibro® Breezhaler), and tiotropium/olodaterol (Spiolto® Respimat)-against tiotropium (Spiriva®), a long-acting muscarinic antagonist (LAMA) used as monotherapy. The primary aim is to assess their impact on exercise capacity, with additional evaluation of pharmacoeconomic outcomes. The study follows a prospective, randomized, open-label, four-period crossover design. Approximately 100 patients with stable COPD will be enrolled from the 2nd Department of Pulmonology and Tuberculosis, Medical University of Białystok, and the University Hospital Pulmonology Outpatient Clinic. Each treatment will last 28 days, separated by a 7-day wash-out period, so that every participant will receive each therapy. Assessments will include standard clinical examinations, lung function testing (spirometry, body plethysmography, DLCO, multiple-breath washout), cardiopulmonary exercise testing (CPET) on a cycle ergometer, the 6-minute walk test, validated questionnaires (SGRQ, CAT, mMRC, BODE index), laboratory tests, and imaging. These procedures are part of routine COPD evaluation and will allow detailed monitoring of respiratory function, exercise tolerance, and quality of life. The study aims to determine whether dual bronchodilation with LABA/uLAMA combinations provides superior improvements in exercise performance and overall efficiency compared to tiotropium alone. Results may help guide clinical decision-making and optimize cost-effectiveness in COPD management.

Állapot (regiszter)
Felfüggesztve
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
100 (tervezett)
Első benyújtás
2026. ápr. 7.
Kezdés
2024. márc. 11.
Elsődleges befejezés
2025. febr. 7.
Fő szponzor
Medical University of Bialystok
NCT-szám
NCT07541378

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Korábbi kezelés

  • Lack of informed consent for study participation
    • No confirmed diagnosis of COPD
    • Age <40 years or >75 years
    • FEV₁ >80% or <30% predicted
    • BMI <15 kg/m² or ≥40 kg/m²
    • Frequent-exacerbator phenotype (≥2 moderate or ≥1 severe exacerbation in the prior 12 months)
    • Inability to self-care or lack of long-term family or caregiver support
    • Recent myocardial infarction (within 6 months before enrollment)
    • Unstable angina
    • Uncontrolled arrhythmias detected on ECG at screening or immediately before CPET
    • Critical aortic stenosis at screening
    • Acute myocarditis or pericarditis
    • Acute cardiovascular conditions such as pulmonary embolism, aortic dissection, or endocarditis
    • Acute systemic conditions that may interfere with exercise testing or worsen under stress (e.g., infections, renal failure, thyrotoxicosis)
    • Deep vein thrombosis
    • Uncontrolled asthma
    • Significant non-COPD lung disease (interstitial lung disease, clinically relevant bronchiectasis, active pulmonary tuberculosis, or untreated OSA with daytime instability)
    • Physical disability preventing safe and adequate CPET performance
    • Cognitive impairment precluding cooperation

Kiket keres a vizsgálat

  • Signed informed consent for study participation
  • Diagnosis of COPD
  • Post-bronchodilator FEV₁/FVC <0.70 (ATS/ERS spirometry)
  • Age ≥40 years and ≤75 years
  • Post-bronchodilator FEV₁ ≤80% and ≥30% predicted, GOLD II-III
  • BMI ≥15 kg/m² and <40 kg/m²
  • Smoking history ≥10 pack-years
  • Clinically stable at enrolment (no acute deterioration requiring a change in treatment)
  • Able to perform CPET (incremental and constant-work-rate at 80% W_peak)

Életkor a regiszterben: 40 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
II Department of Lung Diseases, Lung Cancer and Internal DiseasesBialystokLengyelországIsmeretlen állapot

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