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DOI: 10.1055/s-0035-1544687
Results of three Phase II trials with the long-acting β2-adrenergic agonist (LABA) abediterol in patients with persistent asthma
Introduction: Efficacy and safety of abediterol (LAS100977), a novel LABA in development as a fixed dose combination with an inhaled corticosteroid for the treatment of asthma and COPD, were investigated in 3 Phase II trials in patients with persistent, stable asthma.
Methods: Randomized, double-blind, placebo-controlled, crossover designs were used. Single doses (dose range: 0.313 to 25 µg) of abediterol were administered in the morning via Cyclohaler® (Study 1 and 2) or Genuair® (Study 3). In studies 1 and 3, active comparators (salmeterol and salbutamol, respectively) were used. Change from baseline in FEV1 was assessed and treatment emergent adverse events (TEAEs) were recorded.
Results: Abediterol, in all doses, produced rapid (≤ 15 minutes post-dose), sustained, clinically significant bronchodilation and a significant higher trough FEV1 versus placebo (table). TEAEs were consistent with the drug class and most were mild to moderate in intensity.
*p < 0.001, **p < 0.0001 vs placebo; ††p < 0.0001 vs abediterol (all doses); aper protocol population; bintent-to-treat population Data are LS mean differences from placebo (SE). Trough FEV1 was the mean of the 23 and 24 hour FEV1 values. BID, twice daily; FEV1, forced expiratory volume in 1 second; LS, least squares; N, randomized patients; QD, once daily; SE, standard error |
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Through FEV 1 |
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Study 1 a N= 25 |
Study 2 a N= 28 |
Study 3 b N= 62 |
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Abediterol 0.313 µg QD |
- |
- |
0.219** (0.042) |
Abediterol 0.625 µg QD |
- |
0.281** (0.048) |
0.259** (0.042) |
Abediterol 1.25 µg QD |
- |
0.296* (0.067) |
0.332** (0.042) |
Abediterol 2.5 µg QD |
- |
- |
0.400** (0.042) |
Abediterol 5 µg QD |
0.612** (0.056) |
0.516** (0.049) |
- |
Abediterol 10 µg QD |
0.636** (0.055) |
- |
- |
Abediterol 25 µg QD |
0.665** (0.055) |
- |
- |
Salmeterol 50 µg BID |
0.309**†† (0.055) |
- |
- |
Salbutamol 400 µg QD |
- |
- |
-0.022†† (0.042) |
Conclusions: Abediterol effectively improved bronchodilation in patients with asthma compared with placebo and was safe and well tolerated.