Medical

An EMA Pharmacovigilance Risk Assessment Committee (PRAC) review of published data from controlled clinical trials, observational studies, and meta-analyses has concluded that all inhaled corticosteroid (ICS) products appear to carry a similar risk of pneumonia when used to treat COPD patients but that the benefits of ICS treatment for COPD outweigh the risks. … [Read more...] about EMA review finds that all ICS products carry similar risk of pneumonia but that benefits outweigh the risks

Sunovion has announced that the GOLDEN-3 and GOLDEN-4 Phase 3 clinical trials of SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD both met their primary endpoints. SUN-101, delivered via the PARI eFlow handheld nebulizer, demonstrated statistically significant improvement in FEV1 versus placebo after 12 weeks for both the 50 … [Read more...] about Phase 3 trials of Sunovion’s nebulized glycopyrrolate meet primary endpoints

Mast Therapeutics has announced that the Duke Clinical Research Institute will serve as the coordinating center for the Heart Failure Clinical Research Network (HFN) as it conducts a Phase 2 study of AIR001 sodium nitrite inhalation solution. Earlier this year, Mast reported positive results from a Phase 2a AIR001 for the treatment of heart failure that was conducted … [Read more...] about Mast Therapeutics announces Phase 2 study of AIR001by the Heart Failure Clinical Research Network

An analysis of data from Boehringer Ingelheim's WISDOM study showed that withdrawal of ICS for COPD patients using the Spiriva Handihaler tiotropium bromide DPI plus salmeterol is associated with a higher exacerbation rate in patients with ≥ 4% eosinophils in their blood, according to a new article published in Lancet Respiratory Medicine. Approximately 20% of the … [Read more...] about Eosinophil levels predict effect of ICS added to Spiriva + LABA on exacerbations

In a leading article published in the Archives of Disease in Childhood, Andrew Bush and Louise Fleming of Royal Brompton Hospital and the National Heart and Lung Institute, Imperial College London assert that "the diagnosis of asthma has been trivialized and inhalers dispensed for no good reason, and have become almost a fashion accessory," which has contributed to … [Read more...] about Respiratory specialists call out overdiagnosis of childhood asthma and overprescription of inhalers

Verona Pharma has announced positive data from a Phase 2a study of RPL554, an inhaled PDE3/PDE4 inhibitor for the treatment of acute exacerbations in COPD patients. According to the company, asthma patients who received the nebulized RPL554 experienced no serious adverse events over the entire dose range of 0.4 to 24 mg and demonstrated a maximum bronchodilator effect … [Read more...] about Verona announces positive data from Phase 2a trial of RPL554

The US Department of Health and Human Services has announced that a grant of up to $200,000 is available for "Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation Drug Products." One grant will be awarded. According to the March 15, 2016 announcement, "FDA's CDER is seeking depositional data obtained with a computational modeling … [Read more...] about Grant available for deposition study

Sunovion is presenting observational study data at the Hospital Medicine 2016 conference showing that a substantial number of COPD patients are discharged from hospitals with a prescription for a dry powder inhaler despite their inability to generate sufficient peak inspiratory flow for optimal use of the device. Data from a second study show worse COPD-related … [Read more...] about Sunovion study shows that COPD patients receive DPIs despite insufficient inspiratory flow rate