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GSK, Theravance submit investigational COPD treatment to FDA for review

BY Allison Cerra

LONDON and SOUTH SAN FRANCISCO, Calif. — GlaxoSmithKline and Theravance submitted a regulatory application to the Food and Drug Administration for their chronic obstructive pulmonary disease treatment.

The drug makers said they filed a new drug application for the once-daily investigational medicine fluticasone furoate/vilanterol (FF/VI), which touts the proposed brand name Breo. Breo, administered by the new Ellipta dry powder inhaler, is indicated for the long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, and to reduce exacerbations of COPD in patients with a history of exacerbations. Breo will be available in the 100/25mcg strength.

GSK and Theravance also submitted a regulatory application for the drug to the European Union as a treatment for COPD and asthma.


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Reports: ShopRite to open second ShopRite-branded gas station

BY Antoinette Alexander

ALBANY, N.Y. — Grocery chain ShopRite is opening a ShopRite-branded gas station/convenience store in Albany, N.Y., in September, according to published reports.

The station currently is a Mobil and is located near a ShopRite grocery store on the same block that opened in April, and marks ShopRite’s second branded gas station, according to reports. The first station is located in Middletown, N.Y. The new 16-pump station will offer discounts to holders of the grocer’s Price Plus Club card.

According to reports, ShopRite had discussed plans to start selling gas in the area, but the first site was expected to be located several miles away.

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Vitamin D deficiency associated with poor lung function in child asthmatics

BY Michael Johnsen

NEW YORK — Vitamin D deficiency is associated with poor lung function in asthmatic children treated with inhaled corticosteroids, according to a new study from researchers in Boston released Friday.

“In our study of 1,024 children with mild to moderate persistent asthma, those who were deficient in vitamin D levels showed less improvement in pre-bronchodilator forced expiratory volume in 1 second (FEV1) after one year of treatment with inhaled corticosteroids than children with sufficient levels of vitamin D,” stated Ann Chen Wu, assistant professor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. “These results indicate that vitamin D supplementation may enhance the anti-inflammatory properties of corticosteroids in patients with asthma.”

The findings were published online ahead of print publication in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

The study was conducted using data from the Childhood Asthma Management Program, a multi-center trial of asthmatic children between the ages of 5 years and 12 years who were randomly assigned to treatment with budesonide (inhaled corticosteroid), nedocromil, or placebo. Vitamin D levels were categorized as deficient (≤ 20 ng/ml), insufficient (20-30 ng/ml), or sufficient (> 30 ng/ml).

Among children treated with inhaled corticosteroids, pre-bronchodilator FEV1 increased during 12 months of treatment by 330 ml in the vitamin D insufficiency group and 290 ml in the vitamin D sufficiency group, but only 140 ml in the vitamin D deficient group.

Compared with children who were vitamin D sufficient or insufficient, children who were vitamin D deficient were more likely to be older, be African-American and have higher body mass index. Compared with being vitamin D deficient, being vitamin D sufficient or insufficient was associated with a greater change in pre-bronchodilator FEV1 over 12 months of treatment after adjustment for age, gender, race, BMI, history of emergency department visits, and season that the vitamin D specimen was drawn.

The study had some limitations, including a small sample size of 101 vitamin D deficient children, and the investigators only studied vitamin D levels at one time point, the authors suggested.

“Our study is the first to suggest that vitamin D sufficiency in asthmatic children treated with inhaled corticosteroids is associated with improved lung function,” Wu said. “Accordingly, vitamin D levels should be monitored in patients with persistent asthma being treated with inhaled corticosteroids. If vitamin D levels are low, supplementation with vitamin D should be considered.”


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