A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of inhaled H057 in the treatment of acute exacerbations of bronchiectasis.

Вмешательства

• Препарат Low-dose H057+standard-of-care
  Subjects are administered low-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures.
• Препарат High-dose H057+standard-of-care
  Subjects are administered high-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures.
• Препарат H057 placebo+standard-of-care
  Subjects are administered inhaled H057 placebo, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures.

Первичные конечные точки

• Quality-of-Life Bronchiectasis Respiratory Symptom Score [Срок оценки: baseline to day 15]

Вторичные конечные точки (12)

• Quality-of-Life Bronchiectasis Respiratory Symptom Score [Срок оценки: baseline to day 29 or day 1 post-treatment]
• treatment efficacy rate [Срок оценки: baseline to day 15]
• clinical pulmonary infection score [Срок оценки: baseline to day 15]
• bronchiectasis exacerbation and symptom tool [Срок оценки: baseline to day 29 or day 1 post-treatment]
• Borg Scale [Срок оценки: baseline to day 29 or day 1 post-treatment]
• sputum purulence score [Срок оценки: baseline to day 29 or day 1 post-treatment]
• 24-hour sputum volume [Срок оценки: baseline to day 29 or day 1 post-treatment]
• FEV1%pred [Срок оценки: baseline to day 29 or day 1 post-treatment]
• the frequency of acute exacerbations in bronchiectasis [Срок оценки: day 1 to day 180]
• safety of inhaled H057 in acute exacerbations of bronchiectasis [Срок оценки: day 1 to day 180]
• pharmacokinetic characteristics--Cmax [Срок оценки: day 1 to day 28]
• pharmacokinetic characteristics--Tmax [Срок оценки: day 1 to day 28]

Критерии участия

Критерии включения

Subjects must meet all of the following criteria to be eligible for enrollment in this study:

• Age ≥18 years, regardless of gender;
• Patients who are determined by the investigator to be in an acute exacerbation phase of bronchiectasis prior to enrollment: at least three out of the following six symptoms-cough, changes in sputum volume, purulent sputum, dyspnea or reduced exercise tolerance, fatigue or malaise, hemoptysis-have worsened for more than 48 hours, and the clinician deems that intervention is necessary;
• Able to tolerate nebulized inhalation treatment;
• After instruction, able to correctly use the nebulizer for treatment and accurately complete questionnaires;
• Subjects must fully understand the purpose, nature, methods, and potential adverse events of the trial, voluntarily agree to participate, and sign the informed consent form, or have a legally authorized representative provide informed consent on their behalf.

Критерии исключения

If a subject meets any of the following criteria, they are not eligible to participate in this study:

• Patients with bronchiectasis caused by cystic fibrosis, as determined by the investigator;
• Patients who have experienced an acute exacerbation of bronchiectasis for more than 7 days;
• Patients with an acute exacerbation of bronchiectasis who have received intravenous antibiotic treatment for more than 72 hours prior to enrollment;
• Patients with mild bronchiectasis caused by asthma;
• Patients with comorbid allergic bronchopulmonary aspergillosis, active tuberculosis, or active non-tuberculous mycobacterial infection requiring standardized treatment;
• Patients with moderate or massive hemoptysis during an acute exacerbation of bronchiectasis (moderate hemoptysis: 100-500 mL within 24 hours; massive hemoptysis: >500 mL within 24 hours or a single episode of 100-500 mL);
• Patients with significant liver or kidney dysfunction (ALT, AST >2 times the upper limit of normal \[ULN\]; Cr >1.5 times ULN);
• Patients with a history of malignancy or who have achieved clinical remission for less than 5 years;
• Patients with any other unstable clinical conditions deemed significant by the investigator, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physiological dysfunction, and: a) Whose condition may affect the patient's safety during the study; b) That may impact the study results and their interpretation; c) That may hinder the patient's ability to complete the entire study;
• Patients who are positive for hepatitis B surface antigen (HBsAg) with HBV-DNA >1000 copies/mL or 200 IU/mL, or positive for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or anti-Treponema pallidum antibody;
• Patients who are allergic to the active ingredients or excipients of the investigational product or who have a history of hypersensitivity or an allergic constitution;
• Patients who have participated in other drug or medical device trials within the past 3 months or are currently participating in another clinical trial;
• Pregnant women, lactating women, and women of childbearing potential;
• Subjects whom the investigator considers unsuitable for participation in this study for any reason.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 19 центров

• Fuyang Hospital Of Anhui Medical University — Fuyang
• Hefei First People's Hospital — Хэфэй
• Fujian Medical University Union Hospital — Фучжоу
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Peking University Shenzhen Hospital — Шэньчжэнь
• Affiliated hospital of Youjiang Medical University For Nationalities — Baise City
• Hebei General Hospital — Shijiazhuang
• Nanyang Second General Hospital — Nanyang
• … и ещё 11 центров

Идентификаторы

NCT: NCT06958861 · PH-H057-II-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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