A Phase 3 trial of Flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of COPD has been initiated, according Mundipharma. The 52-week randomized, double-blind EFFECT study compare Flutiform 250/10 μg and Flutiform 125/5 μg with formoterol 12 μg. Flutiform is approved in Europe for the treatment of asthma; it is not approved for the treatment of … [Read more...] about Mundipharma launches Flutiform trial for COPD
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BI presents new data on olodaterol and tiotropium at ERS
Boehringer Ingelheim has presented new data from several Phase 3 studies of olodaterol for the treatment of COPD and from the TIOSPIR tiotropium Respimat study at the European Respiratory Society (ERS) Annual Congress 2013. Data from the olodaterol studies shows that two tested doses of the drug delivered by the Respimat inhaler improved lung function in COPD … [Read more...] about BI presents new data on olodaterol and tiotropium at ERS
Positive Phase 2b results for Theravance investigational LAMA
Theravance has announced that a dose-ranging 7-day Phase 2b study of TD‑4208 inhalation solution, an investigational long-acting muscarinic antagonist (LAMA) for the treatment of COPD, met its primary endpoints for all six doses. TD-4208 showed a statistically significant difference compared to placebo from baseline in trough FEV1 for doses ranging from 22 µg to 700 … [Read more...] about Positive Phase 2b results for Theravance investigational LAMA
Civitas initiates Phase 2B study of CVT-301 inhaled levodopa
Civitas Therapeutics has initiated a 28-day Phase 2b efficacy and safety study of CVT-301 inhaled levodopa for the treatment of intermittent motor fluctuations in Parkinson's patients, the company said. The study is partially funded by a $1 million grant from the Michael J. Fox Foundation for Parkinson's Research. Civitas announced positive results from a Phase 2a … [Read more...] about Civitas initiates Phase 2B study of CVT-301 inhaled levodopa
Study finds tiotropium Respimat safety comparable to tiotropium HandiHaler safety
A study appearing online first in the New England Journal of Medicine finds that "Tiotropium Respimat at a dose of 5 μg or 2.5 μg had a safety profile and exacerbation efficacy similar to those of tiotropium HandiHaler at a dose of 18 μg in patients with COPD." According to the authors, the TIOSPIR randomized, double-blind, parallel-group trial of more than 17,000 … [Read more...] about Study finds tiotropium Respimat safety comparable to tiotropium HandiHaler safety
Trinity College and Woolcock Institute get grant for collaboration
The Respiratory Technology Team of the Woolcock Institute for Medical Research (WIMR) has announced that a $12,000 International Research Collaboration Award from the University of Sydney will fund a collaboration between the team and Carsten Ehrhardt of Trinity College Dublin. Ehrhardt will perform research on drug absorption of inhaled drugs at WIMR during a … [Read more...] about Trinity College and Woolcock Institute get grant for collaboration
Inhaled SYK inhibitor fails to meet endpoints in Phase 2 study
Rigel Pharmaceuticals' R343 inhaled SYK inhibitor has failed to meet primary or secondary endpoints in a Phase 2 study, the company said. As a result, Rigel will discontinue development of the product for the treatment of asthma. The company announced the launch of a Phase 2 study called SITAR ((SYK Inhibition for Treatment of Asthma with R343) in September … [Read more...] about Inhaled SYK inhibitor fails to meet endpoints in Phase 2 study
MannKind announces positive results from Phase 3 study of Afrezza
MannKind Corporation has announced that preliminary results from two Phase 3 clinical studies of Afrezza inhaled insulin met their primary endpoints. In a study in patients with Type 1 diabetes comparing Afrezza to insulin aspart, Afrezza was shown to be non-inferior in A1c level decreases and showed significant reductions in fasting blood glucose and significantly … [Read more...] about MannKind announces positive results from Phase 3 study of Afrezza
Dance Biopharm reports positive results from inhaled insulin study
According to Dance Biopharm, a 12-patient, randomized, semi-blinded Phase 1/2 pharmacokinetic study of its Adagio inhaled insulin in patients with Type 1 diabetes demonstrated the safety of the product and showed that it did not cause coughing. The Samba 01 study also showed consistent delivery of insulin, comparable to delivery by injection. Adagio is an inhalation … [Read more...] about Dance Biopharm reports positive results from inhaled insulin study
Aradigm gets grant for inhaled liposomal ciprofloxacin studies for treatment of NTM
The US National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), has awarded a Small Business Initiative Research (SBIR) grant of approximately $278,000 to Aradigm to study the use of Aradigm’s Pulmaquin and Lipoquin inhaled liposomal ciprofloxacin products for the treatment of pulmonary non-tuberculous mycobacteria … [Read more...] about Aradigm gets grant for inhaled liposomal ciprofloxacin studies for treatment of NTM