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Medical

Study shows significant overdiagnosis of COPD

A study presented at ATS 2013 found that over 40 percent of uninsured patients treated for COPD at a US clinic did not actually have COPD. Researchers from Northeast Ohio Medical University and Saint Elizabeth Health Center in Youngstown assessed 80 patients at a health center in Akron, Ohio using spirometry. All of the patients had either been diagnosed with COPD or … [Read more...] about Study shows significant overdiagnosis of COPD

Prosonix begins Phase 2 study of inhaled glycopyrronium bromide

Prosonix has started a Phase 2 safety and dose-ranging study of PSX1002 inhaled glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), in patients with moderate-to-severe COPD, the company has announced. The suspension formulation of PSX1002 engineered particles is delivered by pMDI. Prosonix CEO David Hipkiss commented, “This trial with PSX1002 is a … [Read more...] about Prosonix begins Phase 2 study of inhaled glycopyrronium bromide

Safety studies show no increased risk with use of Brovana inhalation solution

According to Sunovion Pharmaceuticals, data from a year-long clinical trial comparing the safety of Brovana arformoterol tartrate inhalation solution versus placebo in patients with moderate-to-severe COPD show no increased risk of exacerbations or death due to a respiratory event. Fewer than 10% of patients treated with 15 mcg of Brovana twice daily had serious … [Read more...] about Safety studies show no increased risk with use of Brovana inhalation solution

Pearl Therapeutics initiates Phase 3 program for LAMA/LABA MDI

Pearl Therapeutics has announced the initiation of a Phase 3 program called PINNACLE for its PT003 glycopyrrolate/formoterol fumarate metered dose inhaler for patients with moderate-to-severe COPD. The program will include two studies involving more than 2,700 patients in North America, Europe, Australia, and New Zealand. Enrollment is expected to be complete by … [Read more...] about Pearl Therapeutics initiates Phase 3 program for LAMA/LABA MDI

More positive Phase 3 results for aclidinium/formoterol DPI

Almirall and Forest Labs have announced positive results from the Phase 3 AUGMENT/COPD study of their fixed dose combination aclidinium bromide/formoterol fumarate dry powder inhaler in patients with COPD. The announcement followed several weeks after the companies announced positive results from another Phase 3 study of aclidinium/formoterol, the ACLIFORM/COPD study. … [Read more...] about More positive Phase 3 results for aclidinium/formoterol DPI

QVA149 data demonstrates superior reduction of COPD exacerbations compared to glycopyrronium alone

Novartis's QVA149 indacaterol maleate/glycopyrronium DPI demonstrated 15% greater reduction in all COPD exacerbations compared to glycopyrronium and 14% compared to tiotropium according to study results published April 23 2013 in Lancet Respiratory Medicine. QVA149 reduced moderate-to-severe exacerbations by 12% over glycopyrronium. The study also showed improved lung … [Read more...] about QVA149 data demonstrates superior reduction of COPD exacerbations compared to glycopyrronium alone

Positive Phase 2 results for inhaled L-dopa

In a Phase 2 study of Civitas Therapeutics' CVT-301 inhaled levodopa (L-dopa), Parkinson's disease patients with motor fluctuations (OFF episodes) who used the drug experienced "rapid and durable" motor function improvement, the company announced. The 24-patient randomized, placebo-controlled study was funded in part by a grant from the Michael J. Fox Foundation. … [Read more...] about Positive Phase 2 results for inhaled L-dopa

Impel Neuropharma SPECT imaging study shows nose-to-brain delivery

According to Impel NeuroPharma, the results of a human proof of concept study using SPECT imaging demonstrated nose-to-brain delivery by its Precision Olfactory Delivery (POD) device. The company said that the SPECT images showed deposition of radiolabeled tripeptide by the POD device in the deep nasal cavity and bypassing of the blood brain barrier with delivery to … [Read more...] about Impel Neuropharma SPECT imaging study shows nose-to-brain delivery

Phase 2 study of Savara’s AeroVanc initated

Savara Pharmaceuticals has announced the commencement of a Phase 2 clinical trial of its AeroVanc inhaled dry powder vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. The randomized, double-blind, placebo-controlled study will involve 80 CF patients across the US. Results should be available … [Read more...] about Phase 2 study of Savara’s AeroVanc initated

Positive Phase 3 results for Almirall and Forest’s aclidinium/formoterol DPI

Almirall and Forest Laboratories have announced that a 6-month Phase 3 study of their aclidinium bromide/formoterol fumarate dry powder fixed dose combination delivered by the Genuair (Pressair) inhaler for the treatment of COPD demonstrated statistically significant improvements with both doses tested. The study of more than 1,700 patients found that both the … [Read more...] about Positive Phase 3 results for Almirall and Forest’s aclidinium/formoterol DPI

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