Food Safety for New Hampshire Oysters: A Multidisciplinary Perspective

Oyster aquaculture in New Hampshire is a relatively new industry that has emerged in the last decade. Management of food safety is an integral part of the oyster growing process in this small community. In particular, Vibrio parahaemolyticus is a bacterium that can cause gastrointestinal illness in people who eat raw or undercooked seafood. Recently, New Hampshire created a policy to manage importation of oyster seed for V. parahaemolyticus-related human health concerns. This highlighted a need for data on V. parahaemolyticus in oyster seed. Therefore, the objectives of this research are to examine both social and microbiological aspects of food safety management in the New Hampshire oyster aquaculture community. From a social science perspective, interview and survey data document the experience of industry participants and describe their perspectives on the efficacy and process of food safety management. From a biology perspective, data on V. parahaemolyticus concentrations in juvenile oysters and 16S sequencing data on the microbial community expand our understanding of the microbial implications of oyster importation. A most probable number pipeline (Kaysner and DePaola, 2004) in combination with polymerase chain reaction was used on oyster samples collected over 3 months to compare V. parahaemolyticus concentration in adult vs. juvenile oysters. Samples from the same collection were then used for 16S rRNA sequencing to assess differences in associated microbial communities between age groups and across sample dates. In combination, these multidisciplinary facets are intended to provide managers and industry participants with an analysis of concerns related to water quality and food safety management, a record of interaction experiences between growers and managers, and new microbial data that may inform the management of oyster seed. The results from growers indicate they are mostly satisfied with the effectiveness of food safety management, mostly support a new oyster importation policy, and have positive interactions with state regulators. Microbial results support the scientific underpinnings of the importation policy as a precautionary measure as V. parahaemolyticus was present in juvenile oysters and juvenile microbiomes remained distinct from adult microbiomes for months. Together, these results describe an industry that is operating a management model that minimizes food safety risks, utilizes scientific data, and satisfies the needs of industry members. Elements of this model may be useful to aquaculture industries in other areas looking to develop or improve management strategies

Dose selection for glycopyrrolate/eFlow® phase III clinical studies: results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) phase II dose-finding studies

Abstract Background Long-acting muscarinic antagonists (LAMAs) are recommended for the treatment of chronic obstructive pulmonary disease (COPD). Glycopyrrolate/eFlow® is an investigational drug–device combination of the LAMA glycopyrrolate administered by an eFlow® Closed System (eFlow® CS) nebulizer. The GOLDEN 2 (NCT01706536) and GOLDEN 6 (NCT02038829) Phase II, multicenter studies were conducted to inform dose selection for the GOLDEN Phase III clinical trials. Bronchodilator responses and safety assessments supported dose selection. Methods Subjects with moderate-to-severe COPD were randomized into 28-day parallel-group (GOLDEN 2) or 7-day crossover (GOLDEN 6) studies and received placebo, glycopyrrolate (3, 6.25, 12.5, 25, 50 or 100 μg twice daily [BID]) or aclidinium bromide 400 μg BID. The primary endpoint of both studies was change from baseline in trough forced expiratory volume in 1 s (FEV1). Safety assessments included the incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and discontinuation due to TEAE. Lung function data collected in both studies were pooled. Results The combined GOLDEN 2 (n = 282) and GOLDEN 6 (n = 96) studies included 378 subjects. On Days 7 and 28 there were dose-ordered, statistically significant and clinically important lung function improvements in glycopyrrolate treatment groups. Specifically, on Day 7, glycopyrrolate produced >0.100 L placebo-adjusted changes from baseline in trough FEV1 (12.5 μg BID: 0.122 L; 25 μg BID: 0.123 L; 50 μg BID: 0.137 L) and FEV1 AUC0–12 (12.5 μg BID: 0.145 L; 25 μg BID: 0.178 L; 50 μg BID: 0.180 L). The improvements in lung function for the glycopyrrolate 25 and 50 μg BID doses were comparable to those with aclidinium bromide 400 μg BID (FEV1: 0.149 L; FEV1 AUC0−12: 0.172 L). Acceptable safety profiles were observed across all groups in both studies. Conclusions The efficacy and safety findings supported selection of glycopyrrolate 25 and 50 μg BID doses for the Phase III GOLDEN studies and provided preliminary evidence for the use of nebulized glycopyrrolate as a maintenance therapy for COPD

One-Year Safety and Efficacy Study of Arformoterol Tartrate in Patients With Moderate to Severe COPD

BACKGROUND:Arformoterol tartrate (arformoterol, 15 μg bid) is a nebulized long-acting β2-agonist approved for maintenance treatment of COPD.METHODS:This was a multicenter, double-blind, randomized, placebo-controlled study. Patients (aged ≥ 40 years with baseline FEV1 ≤ 65% predicted, FEV1 > 0.50 L, FEV1/FVC ≤ 70%, and ≥ 15 pack-year smoking history) received arformoterol (n = 420) or placebo (n = 421) for 1 year. The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization.RESULTS:Among 841 patients randomized, 103 had ≥ 1 primary event (9.5% vs 15.0%, for arformoterol vs placebo, respectively). Patients who discontinued treatment for any reason (39.3% vs 49.9%, for arformoterol vs placebo, respectively) were followed for up to 1 year postrandomization to assess for primary events. Fewer patients receiving arformoterol than placebo experienced COPD exacerbation-related hospitalizations (9.0% vs 14.3%, respectively). Twelve patients (2.9%) receiving arformoterol and 10 patients (2.4%) receiving placebo died during the study. Risk for first respiratory serious adverse event was 50% lower with arformoterol than placebo (P = .003). Numerically more patients on arformoterol (13; 3.1%) than placebo (10; 2.4%) experienced cardiac serious adverse events; however, time-to-first cardiac serious adverse event was not significantly different. Improvements in trough FEV1 and FVC were greater with arformoterol (least-squares mean change from baseline vs placebo: 0.051 L, P = .030 and 0.075 L, P = .018, respectively). Significant improvements in quality of life (overall St. George’s Hospital Respiratory Questionnaire and Clinical COPD Questionnaire) were observed with arformoterol vs placebo (P < .05).CONCLUSIONS:Arformoterol demonstrated an approximately 40% lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo. Arformoterol was well-tolerated and improved lung function vs placebo.TRIAL REGISTRY:ClinicalTrials.gov; No.: NCT00909779; URL: www.clinicaltrials.go

One-Year Safety and Efficacy Study of Arformoterol Tartrate in Patients With Moderate to Severe COPD

BACKGROUND:Arformoterol tartrate (arformoterol, 15 μg bid) is a nebulized long-acting β2-agonist approved for maintenance treatment of COPD.METHODS:This was a multicenter, double-blind, randomized, placebo-controlled study. Patients (aged ≥ 40 years with baseline FEV1 ≤ 65% predicted, FEV1 > 0.50 L, FEV1/FVC ≤ 70%, and ≥ 15 pack-year smoking history) received arformoterol (n = 420) or placebo (n = 421) for 1 year. The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization.RESULTS:Among 841 patients randomized, 103 had ≥ 1 primary event (9.5% vs 15.0%, for arformoterol vs placebo, respectively). Patients who discontinued treatment for any reason (39.3% vs 49.9%, for arformoterol vs placebo, respectively) were followed for up to 1 year postrandomization to assess for primary events. Fewer patients receiving arformoterol than placebo experienced COPD exacerbation-related hospitalizations (9.0% vs 14.3%, respectively). Twelve patients (2.9%) receiving arformoterol and 10 patients (2.4%) receiving placebo died during the study. Risk for first respiratory serious adverse event was 50% lower with arformoterol than placebo (P = .003). Numerically more patients on arformoterol (13; 3.1%) than placebo (10; 2.4%) experienced cardiac serious adverse events; however, time-to-first cardiac serious adverse event was not significantly different. Improvements in trough FEV1 and FVC were greater with arformoterol (least-squares mean change from baseline vs placebo: 0.051 L, P = .030 and 0.075 L, P = .018, respectively). Significant improvements in quality of life (overall St. George’s Hospital Respiratory Questionnaire and Clinical COPD Questionnaire) were observed with arformoterol vs placebo (P < .05).CONCLUSIONS:Arformoterol demonstrated an approximately 40% lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo. Arformoterol was well-tolerated and improved lung function vs placebo.TRIAL REGISTRY:ClinicalTrials.gov; No.: NCT00909779; URL: www.clinicaltrials.go

Renal magnesium handling: New insights in understanding old problems

Many sharp-eyed readers have pointed out to us that in the photo next to the article about yams in Ghana (Spore 87, June 2000, page 8), the woman had put all her cassava in one basket, and not the yams she planned to use. Point taken. Whatever you want to point out, point to or point at, your letters, faxes and emails are always welcome at the Spore address in the box on the right. Write now.MailboxMany sharp-eyed readers have pointed out to us that in the photo next to the article about yams in Ghana (Spore 87, June 2000, page 8), the woman had put all her cassava in one basket, and not the yams she planned to use. Point taken...