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This study will assess the efficacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 610 in adults with severe eosinophilic asthma. Plan to recruit 120 subjects, and the subjects divided into 3 groups: 610 100mg group, 610 300mg group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks and follow-up period of 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | 610 100 mg administered subcutaneously every 4 weeks |
|
| Treatment group B | Experimental | 610 300 mg administered subcutaneously every 4 weeks |
|
| placebo Arm Type:no inter | Placebo Comparator | placebo administered subcutaneously every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 610 100mg | Drug | 100mg administered subcutaneously Q4W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16 | FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. | Baseline (Day 1) and at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, and 12 | FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. | Baseline (Day 1) and at week 4,8,12 |
| Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, 12, 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinghong Zhou, MD | Contact | 18911301578 | zhouqinghong@3sbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Qinghong Zhou, MD | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Study Director |
| Min Zhang, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D011657 | Pulmonary Eosinophilia |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 610 300mg |
| Drug |
300mg administered subcutaneously Q4W |
|
| placebo | Drug | administered subcutaneously Q4W |
|
Percentage of FEV1 will be measured using spirometry. |
| Baseline (Day 1) and at week 4,8,12 |
| Number of asthma exacerbation through study week 16 | Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. | From baseline (Day 1) to week 16 |
| Time to first asthma exacerbation event | Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. | From baseline (Day 1) to week 16 |
| Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization) | Asthma exacerbations that are associated with a hospitalization or an emergency room visit. | From baseline (Day 1) to week 16 |
| Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) | Asthma exacerbations that are associated with a hospitalization. | From baseline (Day 1) to week 16 |
| Puffs of rescue medication for asthma exacerbations | Albuterol or levalbuterol for an asthma exacerbation is considered rescue medication. | From baseline (Day 1) to week 16 |
| Change from baseline in Asthma Control Questionnaire score at week 4,8,12,16 | The ACQ has 7 questions- the first 5 items assess the most common asthma symptoms plus 6. short-acting bronchodilator use and 7. FEV1 (pre-bronchodilator use, % and % predicted use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6= maximum impairment). | Baseline (Day 1) and at week 4,8,12,16 |
| Change From Baseline in the St. George's Respiratory Questionnaire Total Score at week 16 | The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health. | Baseline (Day 1) and at week 16 |
| Xin Zhou, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |