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Набор скоро начнётся NCT07425210

Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD

Фаза II С лечением Chronic Obstructive Lung Disease (COLD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: HSK39004 Dry Powder Inhaler -0.75mg BID.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Lung Disease (COLD). Базовые параметры: 40 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Обзор

This clinical trial evaluates the long-term safety and efficacy of 0.75 mg HSK39004 Dry Powder Inhaler administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD), including both newly enrolled and those who have completed prior participation in the HSK39004-201, HSK39004-T1-201, or HSK39004-T1-202 studies as a long-term extension.

Вмешательства

  • Препарат HSK39004 Dry Powder Inhaler -0.75mg BID
    HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day

Первичные конечные точки

  • Treatment-emergent adverse event (TEAE) incidence [Срок оценки: From week 1 to week 53]

Критерии участия

Критерии включения

  • Aged 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;
  • Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and/or a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) <0.7\];
  • At screening visit (Visit 1):
  • Post-bronchodilator FEV1/FVC < 0.7; and
  • Post-bronchodilator FEV1 ≥ 30% and < 80% of predicted value;
  • Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;

Критерии исключения

  • Subjects with unresolved lower respiratory tract infection occurring within 6 weeks prior to screening (Visit 1) and/or before enrollment;
  • Severe or uncontrolled cardiovascular disease or history, including but not limited to: New York Heart Association (NYHA) functional class III/IV at screening; acute myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening; clinically significant arrhythmia requiring intervention or marked QTcF prolongation (male >450 ms, female >470 ms) within 3 months prior to screening; or unstable or uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) at screening;
  • History of malignancy (except for carcinoma in situ, cutaneous squamous cell carcinoma, and basal cell carcinoma cured for more than 5 years), suspected malignancy, or undetermined neoplasm;
  • Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases/abnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis;
  • Known hypersensitivity to HSK39004 inhalation powder, salbutamol, or any component of the drug delivery system;
  • Use of any protocol-prohibited medication prior to spirometry at screening (Visit 1);
  • History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;
  • Major surgery (requiring general anesthesia) within 6 weeks prior to screening with incomplete recovery, or planned surgery before study completion;
  • Subjects determined by the investigator to require oxygen therapy;
  • Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV);

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Guizhou Provincial People's Hospital — Guiyang

Идентификаторы

NCT: NCT07425210 · HSK39004-T1-204

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗