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This study will assess the effcacy 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 effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 36 weeks and follow-up period of 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will receive 610 for 52 weeks. |
|
| Group B | Experimental | Subjects will receive 610 for 52 weeks. |
|
| Placebo group | Placebo Comparator | Subjects will receive placebo for 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 610 | Drug | Subcutaneously injection. |
| |
| 610 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 52 | 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 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes 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 |
| Percentage change from baseline in pre-bronchodilator FEV1 at weeks 4, 8,12,16, 20, 28, 36, 44, 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Zhang, Doctor | 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 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Drug |
Subcutaneously injection. |
|
| Placebo | Drug | Subcutaneously injection. |
|
Percentage of FEV1 will be measured using spirometry. |
| Baseline (Day 1) and at week 4, 8,12,16, 20, 28, 36, 44, 52 |
| Number of asthma exacerbation through study week 52 | Annualized rate of severe exacerbation events during the 52-week placebo-controlled treatment period | From baseline (Day 1) to week 52 |
| Number of asthma exacerbations requiring hospitalization or emergency room visits | Asthma exacerbations that are associated with a hospitalization or an emergency room visit. | From baseline (Day 1) to week 52 |
| Change from baseline in Asthma Control Questionnaire (ACQ) score. | The ACQ contains five symptom questions (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze), one bronchodilator question and pre-bronchodilator FEV1 level. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ score is the average of the responses. Higher score indicates more limitations. | From baseline (Day 1) to week 52 |
| Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ) | The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best. | From baseline (Day 1) to week 52 |
| Assessment of adverse events (AEs) | Number of participants with adverse events (AEs) | Up to week 60 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |