Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1981 · 9 trials · 8 indications
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Change in Induced sputum Eosinophil count (% of total) from baseline
Change in Induced sputum Neutrophils count (% of total) from baseline
Change in Induced sputum Macrophages count (% of total) from baseline
Change in Induced sputum Lymphocytes count (% of total) from baseline
Change in Induced sputum Epithelial cells count (% of total) from baseline
Change in Induced sputum Total cells count from baseline
Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)
Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)
Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).
| Arm | Type | Description |
|---|---|---|
| AZD1981 10 mg | EXPERIMENTAL | AZD1981 10 mg |
| AZD1981 40 mg | EXPERIMENTAL | AZD1981 40 mg |
| AZD1981 100 mg | EXPERIMENTAL | AZD1981 100 mg |
| AZD1981 400 mg | EXPERIMENTAL | AZD1981 400 mg |
| AZD1981 80 mg | EXPERIMENTAL | AZD1981 80 mg |
| AZD1981 200 mg | EXPERIMENTAL | AZD1981 200 mg |
| Placebo | PLACEBO_COMPARATOR | - |
| AZD1981 | EXPERIMENTAL | - |
| AZD1981 50 mg | EXPERIMENTAL | AZD1981 50 mg Twice Daily (Bid) |
| AZD1981 1000 mg | EXPERIMENTAL | AZD1981 1000 mg Twice Daily (Bid) |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | PLACEBO_COMPARATOR | - |
| Treatment A | EXPERIMENTAL | AZD1981, low dose, + Warfarin |
| Treatment B | EXPERIMENTAL | AZD1981, high dose, + Warfarin |
| Name | Type | Description |
|---|---|---|
| AZD1981 | DRUG | AZD1981 twice daily |
| Placebo | DRUG | Placebo to match AZD1981 |
| pravastatin | DRUG | 40 mg, once daily at Day 1, period A and Day 8, period B |
| AZD1981, 2000mg | DRUG | Single oral dose, tablets |
| AZD1981, 200mg | DRUG | Single oral dose, tablets |
| Moxifloxacin, 400mg | DRUG | Single oral dose, capsule |
| Warfarin | DRUG | 10 x 2.5 mg per oral, once daily at day 1 and day 15 |
| Neovletta 21/28 | DRUG | Once daily with (21) or without (28) pause for bleeding. |
| Placebo AZD1981 | DRUG | 4X100 mg per oral, twice daily for 28 days |
| Midazolam | DRUG | Each subject will receive two single doses of 7.5 mg midazolam given as oral solution. The Midazolam dose will be given on Day 1 and on day 16. |
Inclusion Criteria: * Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception * 6 months history of asthma according to ATS definition * Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2 * Pre-bronchodilator FEV1 of 40 ...
AZD1981 is an investigational small molecule being studied for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD). It has also been evaluated in healthy volunteers for pharmacokinetic and drug interaction studies, including its effects on oral contraceptives and the QT interval.
AZD1981 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company has conducted clinical trials to assess the drug's efficacy and safety in patients with moderate to severe COPD.
AZD1981 is in Phase 2 clinical development for moderate to severe COPD. It has completed a Phase 2 efficacy and safety study, along with several Phase 1 trials in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
AZD1981 has completed four clinical trials. The main efficacy study, NCT00690482, was a Phase 2 trial in patients with moderate to severe COPD. Other completed trials include NCT00859352, a Phase 1 study in healthy male volunteers, NCT01110525, a drug interaction study with oral contraceptives, and NCT01265641, a QT interval study.
AZD1981 is the code name for this investigational compound developed by AstraZeneca. No alternative brand names or other designations have been disclosed in the clinical trial records. The drug is identified solely by its development code AZD1981 in all completed studies.
AZD1981 is a small molecule being investigated for respiratory conditions. The specific molecular target or mechanism of action has not been disclosed in the available clinical trial information. The drug's efficacy in COPD was assessed in a placebo-controlled Phase 2 study, but its biological pathway remains unspecified.