Influence of degradable starch microspheres on the human nasal mucosa

The effect of the nasal administration of degradable starch microspheres (DSM) on the mucociliary system and the geometry of the nasal cavities were evaluated in 15 healthy volunteers. The baseline values for mucociliary clearance of the right nasal cavity were determined on two separate days for each subject using the saccharin-dyes test. Acoustic rhinometry was performed before and during the saccharin-dyes test. The patients then started the treatment period and inhaled 10 mg of DSM intranasally once daily in each nostril for 8 days. The saccharin-dyes test was performed 5 min after the deposition of the DSM on day 1 and day 8. The geometry of the nasal cavities was determined before, 7 min after deposition, and after the end of the saccharin test. Both tests were also performed two days after the end of the treatment period. Each subject was examined by means of rhinoscopy on every visit during the investigation. No changes in mucociliary clearance or in the geometry of the nasal cavities were found after repeated administration of starch microspheres. Thus, intranasally-administered degradable starch microspheres did not have an adverse effect on human nasal mucociliary clearance, and the DSM did not cause any congestion or decongestion of the mucosa.