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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02157935 | Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease | PHASE3 | COMPLETED | 2,026 | — | — | Jun 27, 2014 | Feb 8, 2016 | Nov 7, 2017 | 371 | United States, Argentina +9 |
The annual COPD exacerbation rate was analyzed and compared between two arms. Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years. The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model. Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations. Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics. Severe exacerbation: symptoms that require hospitalization (including \>24 hours in ED/urgent care setting).
| Arm | Type | Description |
|---|---|---|
| Symbicort pMDI | ACTIVE_COMPARATOR | Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation |
| Formoterol Turbuhaler | ACTIVE_COMPARATOR | Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation |
| Name | Type | Description |
|---|---|---|
| Symbicort | DRUG | Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses |
| Formoterol turbohaler | DRUG | Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses |
| Placebo for Symbicort pMDI | OTHER | pMDI, aerosol for oral inhalation, placebo, 120 doses |
| Placebo for Formoterol Turbohaler | OTHER | PLacebo powder for oral inhalation, 60 doses |
Inclusion Criteria: 3\. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines. 4\. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year). 5\. Post-bronc...