Pharmacodynamics, pharmacokinetics and safety of revefenacin (TD-4208), a long-acting muscarinic antagonist, in patients with chronic obstructive pulmonary disease (COPD): Results of two randomized, double-blind, phase 2 studies.

Background: Revefenacin (TD-4208) is a potent, lung-selective, long-acting muscarinic antagonist currently in development as a once-daily nebulized therapy for chronic obstructive pulmonary disease (COPD). We evaluated the pharmacodynamics (bronchodilator activity), pharmacokinetics (PK) and safety of single- and multiple-dose administrations of revefenacin in two clinical trials (Study 0059 and Study 0091) in patients with moderate to severe COPD.

Methods: In Study 0059, 32 patients were randomized to receive a single dose of revefenacin (350 or 700 μg), active control ipratropium (500 μg) or placebo inhalation solution administered via standard jet nebulizer in a double-blind, crossover fashion.

An exact method for link parameter estimation in error benchmarking: an application to Phase II two-stage single arm oncology trials.

Bayesian trial designs rely on the specification of a vague data prior to the determination of trial outcome. Phase II two-stage single arm oncology trials have a generally small sample size which may not provide the necessary amount of data to outweigh a misspecified or overly optimistic prior. To account for this issue, clinicians may wish to benchmark Bayesian errors with frequentist measures of trial validity, Type I and Type II errors.

The impact of health insurance coverage on pediatric diabetes management.

Aims: To examine the association between health insurance coverage, insulin management plans, and their impact on diabetes control in a pediatric type 1 diabetes mellitus clinic population.

Methods: Retrospective cohort design drawn from the medical records of the Pediatric Endocrinology Clinic at the University of Louisville, Kentucky.

Results: Out of 701 patients, 223 had public insurance, and 478 had private insurance.

Validity of self-reported smoking status among participants in a lung cancer screening trial.

Lung cancer remains a devastating disease associated with substantial morbidity and mortality. Recent research has suggested that lung cancer screening with spiral computed tomography scans might reduce lung cancer mortality. Studies of lung cancer screening have also suggested that significant numbers of participants quit smoking after screening.