Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 4 2025-521268-37-00

A randomized, double-blind, placebo-controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of mucus plugging and other lung imaging parameters in patients with chronic obstructive pulmonary disease (AEOLUS)

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Respiratory tract diseases

Спонсор: Sanofi-Aventis Recherche & Developpement

Налично на: БГ
Обобщение
Trial status: Authorised Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT), Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT, Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT), Change from baseline to Week 24 in Reactance area (AX) measured by FOT, Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)
Описание
Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT), Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT, Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT), Change from baseline to Week 24 in Reactance area (AX) measured by FOT, Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 184 participants
Интервенции
Dupilumab
Drug
matched placebo for test product
Drug
Ventolin Evohaler 100 micrograms
Drug
Места на провеждане 10
Австрия (1)
Дания (1)
Франция (1)
Германия (1)
Унгария (1)
Италия (1)
Нидерландия (1)
Полша (1)
Испания (1)
Швеция (1)
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
29.09.2025
Регистрационен номер
2025-521268-37-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.