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Набира участници Фаза 2 2024-518821-13-00

A Phase 2b, Multicenter, Randomized, Double-blind, Parallel group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Non-cystic Fibrosis Bronchiectasis

Спонсор: CSL Behring LLC

Налично на: БГ
Обобщение
Trial status: Authorised Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per Participant-year of Follow-up), Number of Participants Achieving a Clinically Important Difference in the Quality of Life–Bronchiectasis (QoL-B) Respiratory Symptoms Scale, Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale, Change From Baseline in QoL-B Respiratory Symptoms Scale, Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria isolated from Sputum, Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs), Percentage of Participants with TEAEs and SAEs TTF (Time to first) Exacerbation
Описание
Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per Participant-year of Follow-up), Number of Participants Achieving a Clinically Important Difference in the Quality of Life–Bronchiectasis (QoL-B) Respiratory Symptoms Scale, Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale, Change From Baseline in QoL-B Respiratory Symptoms Scale, Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria isolated from Sputum, Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs), Percentage of Participants with TEAEs and SAEs
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 226 participants
Интервенции
Placebo, inhalation solution
Drug
Места на провеждане 10
Белгия (1)
Дания (1)
Франция (1)
Германия (1)
Гърция (1)
Унгария (1)
Италия (1)
Нидерландия (1)
Полша (1)
Испания (1)
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
26.09.2025
Регистрационен номер
2024-518821-13-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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