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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00628862 | Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU | PHASE3 | COMPLETED | 613 | — | — | Dec 1, 2007 | Apr 1, 2009 | Oct 25, 2012 | 47 | Bulgaria, Japan +3 |
| NCT00419744 | A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD | PHASE3 | COMPLETED | 1,200 | — | — | Jan 1, 2007 | Aug 1, 2009 | Sep 16, 2010 | 140 | United States, Argentina +7 |
| NCT00206154 | A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients | PHASE3 | COMPLETED | 1,500 | — | — | Apr 1, 2005 | Dec 1, 2006 | Mar 27, 2009 | 212 | United States, Czechia +3 |
| NCT00206167 | A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD | PHASE3 | COMPLETED | 1,600 | — | — | Apr 1, 2005 | Sep 1, 2007 | Mar 27, 2009 | 216 | United States, Bulgaria +7 |
FEV1 (expressed as litres \[L\]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Rate of exacerbations per subject-year
| Arm | Type | Description |
|---|---|---|
| F 4.5 bid | EXPERIMENTAL | Formoterol 4.5 ug twice daily (bid) |
| F 9.0 bid | EXPERIMENTAL | Formoterol 9.0 ug bid |
| PBO | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Formoterol Turbuhaler® 4.5mg | DRUG | 4.5 mg inhaled twice daily |
| Formoterol Turbuhaler® 9 mg | DRUG | 9 mg inhaled twice daily |
| Turbuhaler® placebo | DRUG | placebo inhaled twice daily |
| Budesonide/formoterol (SYMBICORT) pMDI | DRUG | - |
| Formoterol Turbuhaler | DRUG | - |
| Budesonide/formoterol pMDI | DRUG | - |
| Budesonide pMDI | DRUG | - |
Inclusion Criteria: * Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms * Current or previous smoker with a smoking history of 10 or more pack years * Lung function parameters: FEV1/FVC \< 70%, post-bronchodilator and post-bronchodilator FEV1 \< 80% of predi...