Details of the trial (free full text) at January issue of:
sciencedirect.com
Abstract
This was a prospective, open-label, nonrandomized pilot study to evaluate efficacy and tolerability of levalbuterol (LEV) in acute asthma. Asthmatics (forced expiratory volume in 1 second [FEV1], 20?55% predicted) were sequentially enrolled into cohorts of 12 to 14 and received 0.63, 1.25, 2.5, 3.75, or 5.0 mg LEV or 2.5 or 5.0 mg racemic albuterol (RAC) every 20 minutes × 3. After the first dose, FEV1 changes were 56% (0.6 L) for 1.25 mg LEV and 6% (0.07 L) and 14% (0.21 L) for 2.5 and 5 mg RAC respectively. After three doses, FEV1 changes were 74% (0.9 L), 39% (0.5 L), and 37% (0.6 L) for 1.25 mg, LEV 2.5 mg, RAC and 0.63 mg LEV respectively. LEV doses greater than 1.25 mg did not further improve bronchodilation. Baseline plasma (S)-albuterol levels were negatively correlated with baseline FEV1 (R = - 0.3, P = .004) and percent change in FEV1 (R = -0.3, P = .006). LEV at a dose of 1.25 mg produced effective bronchodilation that was greater than both RAC doses. The negative correlation between (S)-albuterol levels and FEV1 could suggest a deleterious effect of (S)-albuterol. Larger comparative studies are warranted.
From the text:
Among all patients and in the subset with baseline FEV1 35% of predicted, 1.25 mg levalbuterol produced a greater degree of bronchodilation after the first dose than both racemic albuterol doses and 0.63 mg levalbuterol. In the subset with more respiratory compromise, the median percent change in FEV1 was more than 10-fold greater than both racemic albuterol doses (75%, compared with 7.5% and 3.2% for 2.5 and 5.0 mg racemic albuterol, respectively).
They should really do a proper trial and nail down this improvement. If they can conclusively demonstrate this, then they should get close to 100% of the hospital market.
Peter |
