Comparative safety and efficacy of two formulations of mometasone nasal spray in adult seasonal allergic rhinitis.

Mometasone furoate as a nasal spray is an effective treatment for seasonal allergic rhinitis (SAR). An aqueous mometasone nasal spray containing the same active substance and excipients as the originator product (reference mometasone) has been developed. This study was designed to establish therapeutic equivalence of test mometasone to reference mometasone and superiority over placebo for the treatment of SAR in adults. In this multicenter, randomized, double-blind, placebo- and active-controlled, fixed-dose study, patients aged ≥18 years with SAR were randomized 2:2:1 to reference mometasone, test mometasone, or placebo for 28 days. Patients recorded nasal and ocular symptoms daily. The primary end point was change from baseline in the pooled 24-hour reflective total nasal symptom score (rTNSS). Safety and tolerability included evaluation by adverse events (AEs), physical (including nasal) examinations, vital signs assessments, laboratory evaluations, and change in concomitant medications. Four hundred two patients received reference mometasone (n = 156), test mometasone (n = 163), or placebo (n = 83). The intent-to-treat population (ITT) comprised 399 patients, and the per-protocol (PP) population comprised 327 patients. The 95% confidence intervals for the treatment difference (reference minus test mometasone) in change from baseline in pooled 24-hour rTNSS were within prespecified equivalence limits for the PP and ITT populations. Both active treatments showed superiority over placebo (p = 0.0019-0.0087). No significant difference was seen between test mometasone and reference mometasone for any secondary efficacy variables. Treatment-emergent AE incidence was low. No deaths or serious AEs were reported. The test mometasone is efficacious in the treatment of SAR in adults and shows a favorable safety profile. The results indicate that the test mometasone is therapeutically equivalent to the reference mometasone.

Computer-aided measurement of psoriatic lesion area in a multicenter clinical trial--comparison to physician's estimations.

BACKGROUND: There is a great need for accurate and informative outcome measures in clinical trials. In psoriasis, therapeutic effect is usually assessed by physician's estimation of psoriatic area and other signs. These measures were found to be un-reproducible. Several automated procedure for more reproducible measurement of psoriatic area were developed, but were not suitable for large-scale trials. OBJECTIVES: In a multicenter clinical trial, we tested a method where the advantage of accurate computerized measurement of the area on the digital photograph was combined with physician's proficiency. METHODS: The patients with psoriasis in four study centers were included in a placebo controlled clinical trial. They were examined and photographed before and after the therapy with calcipotriol ointment or placebo. The psoriatic area was manually outlined on the patient's photographs and the area was automatically measured by a computer. The areas estimated by physician and measured by computer were compared. RESULTS: We found that computer-aided measurement of psoriatic lesion area improved the power of the clinical trial, compared to the standard approach, where physician's estimations of the psoriatic lesion area tend to overestimate. We also found that adapted PASI index, where the psoriatic area was not converted into an area grade, but was maintained as a continuous variable, also improved the power of the clinical trial. CONCLUSIONS: Computer-aided measurement and an adapted PASI can be used as a powerful and reliable measure to evaluate the effects of antipsoriatic treatment.

Nonradioactive northern blotting for the determination of acetylcholinesterase mRNA. Comparison to the radioactive technique.

A sensitive nonradioactive northern blotting for the detection of acetylcholinesterase mRNA in mammalian tissues is described and compared to its radioactive version. Best results were obtained if digoxigenin labeled RNA probe was used for hybridization and CDP-Star™, a chemiluminescent alkaline phosphatase substrate, for detection. The described nonradioactive technique for acetylcholinesterase mRNA determination is as sensitive as the radioactive one, but requires no protection against radiation and is less time consuming. Because of higher stability of the labeled probe, nonradioactive technique is also more convenient from the standpoint of experimental planning.