Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 853 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 853 | Drug | AMG 853 5 mg (BID) |
| |
| AMG 853 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA) | Baseline to Week 12 | |
| Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days) | Baseline to Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23174659 | Background | Busse WW, Wenzel SE, Meltzer EO, Kerwin EM, Liu MC, Zhang N, Chon Y, Budelsky AL, Lin J, Lin SL. Safety and efficacy of the prostaglandin D2 receptor antagonist AMG 853 in asthmatic patients. J Allergy Clin Immunol. 2013 Feb;131(2):339-45. doi: 10.1016/j.jaci.2012.10.013. Epub 2012 Nov 20. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C573852 | vidupiprant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
AMG 853 200 mg (QD) |
|
| AMG 853 | Drug | AMG 853 25 mg (BID) |
|
| AMG 853 | Drug | AMG 853 100 mg (BID) |
|
| Placebo | Drug | Placebo |
|
| Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) | Baseline to Week 12 |
| Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR) | Baseline to Week 12 |
| Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ) | Baseline to Week 12 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |