The study was designed to ascertain whether a safe dose of this PDE3/4 inhibitor, given by inhalation to a group of clinically stable, mild asthmatic patients that were not on maintenance anti-asthma therapy, produced bronchodilation (relaxation of airways) as well as bronchoprotection (protection against the airway stimulant methacholine). In a separate group of asymptomatic patients with allergic rhinitis who were not on maintenance therapy, the effects of the drug on the inflammatory cellular responses to a nasal allergen challenge were tested.
This nebulized PDE3/4 inhibitor did not produce adverse events in healthy subjects, allergic asthmatics or allergic rhinitics.
In asthmatics, the PDE3/4 inhibitor induced a statistically and clinically significant bronchodilation. The drug also induced a statistically and clinically significant bronchoprotection against methacholine challenge.
In the allergic rhinitis group, the same single dose of the PDE3/4 inhibitor reduced the percentage of inflammatory cells (eosinophils and neutrophils) obtained from the nose 7 hours after allergen challenge. However, this reduction in inflammatory cells failed to reach statistical significance, possibly due to the large variability in the eosinophil counts and a limited population size. These findings warrant further studies with multiple and/or higher doses of this PDE3/4 inhibitor in larger study populations.
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