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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02491684 | A Study in Asthma Patients to Evaluate Efficacy, Safety and Tolerability of 14 Days Once Daily Inhaled Interferon Beta-1a After the Onset of Symptoms of an Upper Respiratory Tract Infection | PHASE2 | COMPLETED | 121 | — | — | Jul 21, 2015 | Nov 24, 2016 | Feb 12, 2019 | 35 | Argentina, Australia +5 |
Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing severe exacerbations during the 14 day treatment phase following the onset of an URTI in asthmatic patients. A severe exacerbation was defined as worsening asthma symptoms and 1. use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least 3 consecutive days and/or 2. an unscheduled visit or emergency room visit due to asthma symptoms that required at least 1 dose of systemic corticosteroids and/or 3. an in-patient hospitalisation due to asthma requiring at least 1 dose of systemic corticosteroids. The number of patients with severe asthma exacerbations with onset during the treatment phase is presented for each treatment group.
| Arm | Type | Description |
|---|---|---|
| Placebo (matching) | PLACEBO_COMPARATOR | Placebo, once daily inhalation for 14 days |
| Interferon beta-1a | EXPERIMENTAL | Interferon beta-1a, 24 μg (metered dose) once daily inhalation for 14 days |
| Name | Type | Description |
|---|---|---|
| Interferon beta-1a Nebuliser solution 48 μg/mL | DRUG | Interferon beta-1a, 0,5 ml (24 μg, metered dose) once daily inhalation for 14 days |
| Placebo | DRUG | Placebo solution for once daily inhalation for 14 days |
Inclusion Criteria: For inclusion in the study patients should fulfil the following criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures 2. Male or female aged 18 and above at the time of enrolment 3. History of physician-diagnosed asthma requi...