TABLE 3.
Clinical efficacy of roflumilast on asthma patients in clinical trials.
| Author, year | Patient characteristic | Interventions | Duration (weeks) | Outcomes |
|---|---|---|---|---|
| Bousquet et al. (2006) | Mild asthma, FEV1 50–85% | RF 5000 µg OD vs. BDP 200 µG BID | 12 weeks | Comparable effect of RF and BDP for improving FEV1 and FVC. Improved asthma symptom scores and reduced rescue medication use from baseline |
| Timmer et al. (2002) | Exercise-induced asthma | RF 500 µg vs. PBO OD | 4 weeks | RF prevents FEV1 fall after exercise challenge in days 1 and 14 compared to PBO. Reduced LPS-stimulated TNF-α |
| Bateman et al. (2016) | Moderate-to-severe asthma that remained uncontrolled asthma despite ICS/LABA | RF 500 µg plus MT 10 mg vs. PBO plus MT 10 mg (cross-over) | 4 weeks | RF plus MT increased FEV1 and FVC compared to PBO plus MT. RF plus MT improved ACQ-5 and ACQ-7 from baseline but not different from PBO plus MT. Reduced urinary LTE4 |
ICS, inhaled corticosteroid; RF, roflumilast; PBO, placebo; BDP, beclomethasone dipropionate; MT, montelukast; ICS/LABA, inhaled corticosteroid/long-acting β2 agonist; OD, once daily; BID, twice a daily; ACQ, asthma control questionnaire (ACQ); LPS, lipopolysaccharide; TNF-α, tumor necrosis factor-alpha; LTE4, leukotriene E4.