A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Обзор

The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.

Вмешательства

• Препарат HRS-9821 Inhalation Suspension
  HRS-9821 Inhalation Suspension.
• Препарат HRS-9821 Placebo Inhalation Suspension
  HRS-9821 Placebo Inhalation Suspension.

Первичные конечные точки

• Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment. [Срок оценки: From baseline to 28 days after treatment.]

Вторичные конечные точки (6)

• Changes in FEV1 area under the curve versus time from 0 to 12 hours (AUC0-12h) and 0 to 4 hours (AUC0-4h) after 1, 14 and 28 days of treatment. [Срок оценки: During 28 days of treatment.]
• Changes in peak FEV1 after 1 and 14 days of treatment. [Срок оценки: After 1 and 14 days of treatment.]
• Changes in trough FEV1 after 1, 14 and 28 days of treatment. [Срок оценки: After 1, 14 and 28 days of treatment.]
• Changes in FVC (forced vital capacity) during 28 days of treatment. [Срок оценки: During 28 days of treatment.]
• Changes of in SGRQ (St. George's Respiratory Questionnaire), CAT (COPD Assessment Test), mMRC (modified Medical Research Council） score during 28 days of treatment. [Срок оценки: During 28 days of treatment.]
• The use of SABA (Short-Acting Beta₂ Agonist) during 28 days of treatment. [Срок оценки: During 28 days of treatment.]

Критерии участия

Критерии включения

• Age ≥ 40 years old and < 80 years old, male or female.
• Meet the weight standard.
• Smoking history ≥ 10 pack-years.
• COPD has been diagnosed ≥ 1 year.
• 4 weeks before screening, the background treatment for COPD was stable.
• FEV1/FVC < 0.7, 30% ≤ FEV1 ≤ 80%.
• mMRC score ≥ 2.
• The inspection and medication can be completed as required.
• Non-pregnant and breastfeeding state.
• Able and willing to provide a written informed consent.

Критерии исключения

• History of life-threatening COPD.
• Other pulmonary diseases that may affect the efficacy evaluation of this study.
• Concurrent diseases other than COPD that may affect lung function.
• History of asthma.
• Pulmonary heart disease requiring clinical intervention, or moderate to severe pulmonary hypertension.
• Malignant tumors within 5 years.
• Uncontrolled severe cardiovascular and cerebrovascular diseases within 1 year.
• Unstable diseases.
• Acute exacerbation of COPD within 12 weeks, hospitalization for COPD or pneumonia within 6 months.
• Infection in the lungs or other parts occurs within 16 weeks and requires treatment.
• Immunosuppression.
• Uncontrolled hypertension.
• Lung resection, surgical lung volume reduction or endoscopic treatment for COPD.
• Undergone major surgery or planned surgery within 14 months.
• Abnormal chest images have clinical significance.
• Tuberculosis infection requiring treatment within 16 to 12 months.
• Virological test result was positive.
• Laboratory blood tests and electrocardiograms were significantly abnormal.
• Requires oxygen inhalation or intermittent oxygen inhalation therapy.
• Hypercapnia, using or requiring long-term use of any non-invasive positive pressure ventilation device.
• Biological agents that may have therapeutic effects on the studied disease have been used within 12 weeks or within 5 half-lives of the drug.
• Vaccination, theophylline or drugs within 4 weeks.
• Having participated in other clinical studies within 4 weeks and used research drugs or medical devices containing active ingredients, or still within 5 half-lives of the research drug.
• Systemic glucocorticoids, immunosuppressants, and oral Roflumilast within 12 weeks.
• Undergoing or planning rehabilitation treatment for pulmonary rehabilitation.
• Non-selective β blockers within 1 week.
• Overly potent/moderately potent drugs that inhibit or induce the liver drug-metabolizing enzyme CYP3A4 within 14 days.
• Allergic to the research drug or salbutamol or excipients.
• Has been used HRS-9821.
• Drug abuse and alcohol abuse within 1 year.
• Pregnant or lactating period or planning to be pregnant or lactating.
• The researchers judged that there were other unsuitable circumstances.

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

• Shanghai Tongji Hospital — Шанхай

Идентификаторы

NCT: NCT07640451 · HRS-9821-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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