Clinical study on beclomethasone dipropionate powder preparation (TL-102) in perennial nasal allergy

Abstract

The efficacy, safety and optimal dose of TL-102, a powder mixture of beclomethasone dipropionate (BDP) and hydroxypropylcellulose (HCP) were studied in 250 patients with perennial nasal allergy in an intergroup comparative double-blind manner. Four different capsules containing respectively 30 micrograms of HCP and 1.5 micrograms, 12.5 micrograms, 25 micrograms and 50 micrograms of BDP, were prepared and the drug was applied intranasally evenly between both nostrils at a dose of 2 cap./day b.i.d. for one week. The degrees of overall improvement, usefulness, improvement of nasal symptoms (sneezing, nasal discharge, nasal blockage) and improvement of rhinoscopical findings (mucosal swelling and nasal secretion) were found to be dose-dependent. Antigen provocation reaction and nasal eosinophil count were both inhibited as compared with the TL 1.5 g group. The incidence of side effects was 4.5%, but all side effects observed were mild. Using TL-102 resulted in a therapeutic effect comparable to the conventional BDP preparations using a dose 1/4th of the normal dose of these BDP preparations. The incidence of side effects was 1/3th in comparison with conventional BDP. It was suitable to administer BDP 50 micrograms capsule containing 30 mg of HCP twice a day.