A study of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol in patients with seasonal allergic rhinitis from mountain cedar pollen.

A nasal aerosol formulation of ciclesonide with a hydrofluoroalkane propellant (CIC-HFA) is currently in development for treatment of allergic rhinitis (AR). This study evaluated the efficacy and safety of once-daily administration of CIC-HFA 74 or 148 micrograms compared with placebo in patients with seasonal AR (SAR) from mountain cedar pollen. Patients ≥12 years of age with a ≥2-year history of SAR from mountain cedar pollen were randomized in a placebo-controlled, double-blind, parallel group, multicenter study to CIC-HFA 74 micrograms, CIC-HFA 148 micrograms, or placebo once daily in the morning for 2 weeks.

Quality control in longitudinal studies with computed tomographic densitometry of the lungs.

To guarantee the reliability of densitometric data in clinical trials on pulmonary emphysema a quality control procedure is presented, to prevent that a measured progression in lung density could be reflected by a gradual change in the maintenance of the computed tomographic scanner. For that purpose, a foam phantom has been developed, which mimicks the densities of emphysematous lung tissue, fixed in a sealed Perspex box. Analysis software was developed to automatically compare the density readings with a baseline reference.