A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With COPD

Официальное название

A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Обзор

The purpose of this study is to evaluate the efficacy and safety of HSK39004 Inhalation Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Вмешательства

• Препарат HSK39004 Inhalation Suspension
  Dosage Formulation: HSK39004 Inhalation suspension Dosage 3mg，Twice Daily for 24 weeks
• Препарат Placebo control
  Dosage Formulation: Placebo Inhalation suspension Dosage 0mg，Twice Daily for 24 weeks

Первичные конечные точки

• Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12 [Срок оценки: Baseline (pre-dose on Day 1) and Week 12]

Вторичные конечные точки (5)

• Change from Baseline in peak FEV1 within 4 hours after administration at week 4, 8, 12, 18, 24 [Срок оценки: Baseline (pre-dose on Day 1) and Week 4, 8, 12, 18, 24]
• Change from Baseline in Morning trough FEV1 after administration at week 4, 8, 12, 18, 24 [Срок оценки: Baseline (pre-dose on Day 1) and week 4, 8, 12, 18, 24]
• Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-4h) at Week 4, 8, 12, 18, 24 [Срок оценки: Baseline (pre-dose on Day 1) and Week 4, 8, 12, 18, 24]
• Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 12 and 24 [Срок оценки: Day1, Weeks 12 and 24]
• Treatment-emergent adverse event (TEAE) incidence [Срок оценки: From week 1 to week 25]

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

• Known hypersensitivity to HSK39004 inhalation suspension, salbutamol, or any component of the drug delivery system;
• History of life-threatening acute exacerbation of COPD;
• Acute exacerbation of COPD (excluding the use of short-acting bronchodilators alone) or hospitalization for pneumonia within 12 weeks prior to screening (Visit 1);
• Acute (viral or bacterial) upper or lower respiratory tract infection within 6 weeks prior to screening (Visit 1);
• Diagnosis of any other clinically significant respiratory disease besides COPD, including but not limited to: alpha-1 antitrypsin deficiency, bronchial asthma, active tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, bronchiolitis obliterans, pulmonary sarcoidosis, or clinically significant idiopathic pulmonary fibrosis, pulmonary arterial hypertension, bronchiectasis (except asymptomatic localized bronchiectasis) that, in the opinion of the investigator, poses a safety risk to the participant or may affect the analysis of study result;
• Severe or uncontrolled cardiovascular disease or history;
• 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;
• History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;
• 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT07658339 · HSK39004-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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