Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00297102 | Pulmonary Disease, Chronic Obstructive | COPD Exacerbation Rate (Moderate or Severe) 52 weeks treatment period | Placebo | 1.266 exacerbations per patient per year |
| Roflumilast | 1.077 exacerbations per patient per year | |||
| NCT00297102 | Pulmonary Disease, Chronic Obstructive | Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) Change from baseline over 52 weeks of treatment | Placebo | 8 mL (±8 Standard Error) |
| Roflumilast | 46 mL (±8 Standard Error) | |||
| NCT00297115 | Pulmonary Disease, Chronic Obstructive | COPD Exacerbation Rate (Moderate or Severe) 52 weeks treatment period | Placebo | 1.485 exacerbations per patient per year |
| Roflumilast | 1.210 exacerbations per patient per year | |||
| NCT00297115 | Pulmonary Disease, Chronic Obstructive | Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) Change from baseline over 52 weeks of treatment | Placebo | -25 mL (±7 Standard Error) |
| Roflumilast | 33 mL (±7 Standard Error) | |||
| NCT00313209 EOS | Pulmonary Disease, Chronic Obstructive | Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) Change from baseline over 24 weeks of treatment | Placebo | -10 mL (±9 Standard Error) |
| Roflumilast | 39 mL (±9 Standard Error) | |||
| NCT00424268 HELIOS | Pulmonary Disease, Chronic Obstructive | Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) Change from baseline over 24 weeks of treatment | Placebo | -16 mL (±12 Standard Error) |
| Roflumilast | 65 mL (±12 Standard Error) | |||
| NCT01313494 ACROSS | Pulmonary Disease, Chronic Obstructive | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) Baseline to Week 24 | Placebo | -0.022 liters (±0.009 Standard Error) |
| Roflumilast | 0.049 liters (±0.009 Standard Error) | |||
| NCT01509677 | Pulmonary Disease, Chronic Obstructive | Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue Baseline to 16 weeks | Placebo | 29.4 cells/mm^2 (±298.88 Standard Deviation) |
| R500 | 13.4 cells/mm^2 (±302.69 Standard Deviation) | |||
| NCT01509677 | Pulmonary Disease, Chronic Obstructive | Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. 16 weeks | Placebo | 427.1 CD8+ cells count (±261.42 Standard Deviation) |
| R500 | 442.4 CD8+ cells count (±312.74 Standard Deviation) | |||
| NCT01973998 | Pulmonary Disease, Chronic Obstructive | Time to All-cause Mortality or Re-hospitalization During the 180 Days Post-randomization. 180 days | Placebo | 55 Days to event |
| Roflumilast | 54 Days to event | |||
| NCT02165826 OPTIMIZE | Pulmonary Disease, Chronic Obstructive | Percentage of Participants Prematurely Discontinuing Study Treatment Due to Any Reason Baseline to Week 12 (Main Period) | Roflumilast 250 μg OD Then 500 μg OD | 18.4 percentage of participants |
| Roflumilast 500 μg EOD Then 500 μg OD | 20.1 percentage of participants | |||
| Roflumilast 500 μg OD | 24.6 percentage of participants | |||
| NCT02340520 | Pulmonary Disease, Chronic Obstructive | Bronchodilation Baseline, Week 1 and 2 | Theophylline and Roflumilast | 1.18 liters (±0.51 Standard Deviation) |
| Theophylline and Roflumilast | 2.72 liters (±0.78 Standard Deviation) | |||
| Theophylline and Roflumilast | 1.22 liters (±0.51 Standard Deviation) | |||
| Theophylline and Roflumilast | 2.90 liters (±0.82 Standard Deviation) | |||
| Theophylline and Roflumilast | 1.18 liters (±0.51 Standard Deviation) | |||
| Theophylline and Roflumilast | 2.72 liters (±0.68 Standard Deviation) | |||
| Theophylline and Roflumilast | 1.25 liters (±0.58 Standard Deviation) | |||
| Theophylline and Roflumilast | 2.79 liters (±0.71 Standard Deviation) | |||
| Theophylline and Roflumilast | 1.18 liters (±0.51 Standard Deviation) | |||
| Theophylline and Roflumilast | 2.81 liters (±0.61 Standard Deviation) | |||
| Theophylline and Roflumilast | 1.24 liters (±0.54 Standard Deviation) | |||
| Theophylline and Roflumilast | 2.80 liters (±0.65 Standard Deviation) | |||
| Theophylline and Roflumilast | 1.30 liters (±0.47 Standard Deviation) | |||
| Theophylline and Roflumilast | 2.98 liters (±0.67 Standard Deviation) | |||
| NCT04211363 DERMIS-1 | — | Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8 Baseline (Day 1) and Week 8 | Rofumilast Cream 0.3% | 108 Participants |
| Vehicle Cream | 8 Participants | |||
| NCT04773587 INTEGUMENT-I | — | Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 Week 4 | Roflumilast Cream 0.15% | 32.0 percentage of participants |
| Vehicle Cream | 15.2 percentage of participants | |||
| NCT04773600 | — | Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 Week 4 | Roflumilast Cream 0.15% | 28.9 percentage of participants |
| Vehicle Cream | 12.0 percentage of participants | |||
| NCT04845620 | — | Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 Week 4 | Roflumilast Cream 0.05% | 25.4 percentage of participants |
| Vehicle Cream | 10.7 percentage of participants | |||
| NCT04973228 | Dermatitis, Seborrheic | Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 Week 8 | Roflumilast Foam 0.3% | 80 percentage of participants |
| Vehicle Foam | 58 percentage of participants | |||
| NCT05028582 ARRECTOR | — | Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8 Week 8 | Roflumilast Foam 0.3% | 45.5 percentage of participants |
| Vehicle Foam | 20.1 percentage of participants | |||
| NCT05028582 ARRECTOR | — | Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8 Week 8 | Roflumilast Foam 0.3% | 66.4 percentage of participants |
| Vehicle Foam | 27.8 percentage of participants |