Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02898662 | AZD1419 Ph2a Study | PHASE2 | COMPLETED | 81 | — | — | Oct 12, 2016 | Sep 25, 2018 | Nov 6, 2019 | 15 | Denmark, Hungary +2 |
LOAC was defined as any of the following: * Increase of asthma control questionnaire-5 (ACQ-5) to ≥ 1.5. * ≥ 30% reduction in morning peak expiratory flow (PEF) from baseline on 2 consecutive days. * ≥ 6 additional reliever inhalations of short-acting β agonist (SABA) in a 24-hour period relative to baseline on 2 consecutive days. * Exacerbation requiring systemic corticosteroids as decided by Investigator. Time to LOAC was calculated as start date of first LOAC - date of randomization + 1. Start date of LOAC was latest date that 1 of the 4 criteria were satisfied immediately prior to the exacerbation start date, provided no more than 7 days between LOAC and exacerbation start date. Time to LOAC was displayed using a Kaplan-Meier plot and the outcome measure is presented as number of participants with events. Cox regression analysis was used to compare treatments.
| Arm | Type | Description |
|---|---|---|
| AZD1419 | EXPERIMENTAL | Dose adaption of AZD1419, 4 mg or 8 mg or 1 mg based on occurence of AE's |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| AZD1419 | DRUG | Inhaled AZD1419 administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events |
| Placebo | DRUG | Inhaled Placebo administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is Placebo 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events |
Inclusion Criteria: * Male and female patients 18 years and above * Physician-diagnosed asthma requiring treatment with ICS and a long-acting beta agonist (LABA). Patients must have taken ICS plus LABA controller medication for at least 3 months prior to screening * Pre-bronchodilator forced expira...