Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers
Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
Participant gender:
Summary
Inflammation clearly contributes to the progression of the cystic fibrosis (CF) lung disease,
and administration of the anti-inflammatory agent high-dose ibuprofen retards the rate of
decline of pulmonary function. However, utilization of this valuable drug has been suboptimal
because of its rare, but dramatic, adverse effects. Therefore, alternative anti-inflammatory
agents are urgently needed. One strategy for identifying new anti-inflammatory agents is to
determine the mechanism by which the only proven anti-inflammatory agent for the CF lung
disease, high-dose ibuprofen, exerts its effect. If this were known, then other drugs that
act by a similar mechanism become candidates for treating the CF inflammatory disease. The
investigators have shown, in our preliminary studies, that high dose ibuprofen limits the
delivery of neutrophils to an inflamed mucosal surface, the gingival crevices. The
investigators plan to test pioglitazone and simvastatin, (ibuprofen (positive control)) to
determine their anti inflammatory affects on neutrophil migration to the oral mucosa.
The hypothesis to be tested is that pioglitazone, and/or simvastatin will reduce neutrophils
in the oral mucosa after 10 days of therapy in mouthwashes of healthy volunteers. Ibuprofen
will be used as a positive control.
This study will provide pilot data from healthy volunteers to support an FDA Grant to be
submitted at a future date.