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Biomedical subjects

Robert J Meyer

Publications and source records attributed to Robert J Meyer.

6 recordsLinked to original sources
PubMed2005

U.S. regulatory perspective on the minimal clinically important difference in chronic obstructive pulmonary disease.

This paper outlines the regulatory issues surrounding the determination and use of minimally clinically important differences (MCID) in assessing measures of outcomes from treatments of chronic obstructive pulmonary disease (COPD). To place this discussion in context, it is important to understand the current state of approved therapies for COPD, as well as newer directions in therapy. This paper discusses the currently available, approved drug therapies for COPD in the United States and how they were approved. This is followed by an overview on the use of MCID for assessing outcomes in therapies for COPD, as well the more general experience with MCID from the U.S. regulatory perspective.

Clinical Trials as Topic↗
PubMed2003

Serious asthma exacerbations in asthmatics treated with high-dose formoterol.

OBJECTIVE: To review three prospective, randomized, placebo-controlled, double-blind clinical studies of formoterol (Foradil Aerolizer; Novartis Pharmaceuticals; Basel, Switzerland) at dosages of 12 microg and 24 microg bid for the treatment of patients with asthma. DATA SOURCES: Clinical studies submitted to the US Food and Drug Administration in support of the approval of Foradil Aerolizer for marketing in the United States. RESULTS: More patients treated regularly with formoterol, 24 micro g bid, had a serious asthma exacerbation than did patients who had been treated with placebo. In the first study, 4 of 135 adult patients (3%) who had been treated with formoterol, 24 microg bid, had a serious asthma exacerbation compared to none of 136 placebo-treated patients. In the second study, 5 of 136 patients (3.7%) treated with formoterol, 24 microg bid, had a serious asthma exacerbation compared to 2 of 141 placebo-treated patients (1.4%). In the third study, 11 of 171 pediatric patients (6.4%) treated with formoterol, 24 microg bid, had a serious asthma exacerbation compared to none of 176 placebo-treated patients. CONCLUSION: Regular use of high-dose inhaled formoterol (24 microg bid) may be associated with more frequent serious asthma exacerbations.

Administration, Inhalation↗
PubMed2003

Inhaled fluticasone propionate by diskus in the treatment of asthma: a comparison of the efficacy of the same nominal dose given either once or twice a day.

STUDY OBJECTIVE: In September 2000, the US Food and Drug Administration (FDA) approved the use of Flovent Diskus (FD) [fluticasone propionate; GlaxoSmithKline; Research Triangle Park, NC], which is an orally inhaled, dry-powder corticosteroid, for the maintenance treatment of asthma at dosages of 50 to 1,000 microg administered twice-daily. Once-daily dosage regimens did not receive approval. This article will detail six clinical trials, five of which incorporated comparative once-daily and twice-daily treatment arms of the same nominal dose of FD. DESIGN: Six 12-week, randomized, double-blind, placebo-controlled studies in patients with mild-to-moderate asthma, including two pediatric asthma trials (patient age, 4 to 11 years) of total daily doses of fluticasone propionate (FP) of 100 or 200 microg, and four adult and adolescent studies of total daily doses of FP of 100, 200, or 500 microg. RESULTS: Twice-daily dosing was numerically superior to once-daily dosing at the same nominal dose in all comparative studies for the primary end point, change in predose FEV(1). In five trials, the results of the once-daily dosage of FP were statistically indistinguishable from those with placebo. One trial demonstrated the superiority of FP, 500 microg once-daily, over placebo; however, the effect size was half that observed with twice-daily dosing. Once-daily FP dosing showed no advantage in safety or in patient adherence to medication. CONCLUSIONS: In the FDA review of once-daily dosing of the FD regimen, 100 or 200 microg once-daily dosing was not shown to be significantly better than placebo. FP 500 microg once-daily was found to be superior to placebo, but at about one half the effect size as the same nominal dose given bid. No advantage in patient safety or adherence was demonstrated for once-daily administration over twice-daily administration, and once-daily administration is not currently recommended.

Administration, Inhalation↗
PubMed2002

Bringing new nebulizer technologies to market: regulatory issues.

This review outlines regulatory issues involved in bringing new nebulizer technologies to market and describes the regulatory roles of the Center for Devices and Radiologic Health and the Center for Drug Evaluation and Research. The responsible agency is determined by whether a new device involves a new drug formulation.

Device Approval↗