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Recent news about companies that support development and manufacture of OINDPs, as well as on research and progress in asthma treatment. 8 April 2018 Inhalation Industry news Pulmatrix begins Phase I clinical trial of Pulmazole LEXINGTON, MASSACHU- SETTS—PR Newswire reported that Pulmatrix has begun its first-in- h u m a n s t u d y o f P u l m a z o l e (PUR1900), an inhaled iSPERSE ™ formulation of itraconazole, an anti-fungal drug for treatment of allergic bronchopulmonary asper- gillosis (ABPA) in asthma patients. ISPERSE is the company's propri- etary dry powder delivery platform. Pulmatrix believes Pulmazole to be the first inhaled dry powder version of itraconazole advanced into clini- cal development. ABPA is currently treated with Sporanox ® (Janssen) oral itraconazole and corticosteroids but the regimen poses concerns about bioavailability, pharmacoki- netics, toxicity, side effects and drug/drug interactions. e phase 1/1b study will include single a s c e n d i n g d o s e a n d m u l t i p l e ascending dose arms while a third arm will evaluate safety and tolera- bility, and a pharmacokinetic (PK) analysis following Sporanox or Pul- mazole dosing in a crossover study. The company expects top line results in mid-2018 and anticipates they will corroborate key preclinical findings that Pulmazole can provide higher lung exposure and lower sys- temic exposure than oral Sporanox. AZ triple combination COPD inhaler meets phase III targets CAMBRIDGE, UNITED KING- DOM—Pharma Times Online has reported AstraZeneca's announce- ment of top-line clinical trial data supporting its PT010 triple combi- nation therapy being developed for use with its Aerosphere ® technology in patients with chronic obstructive p u l m o n a r y d i s e a s e ( C O P D ) . PT010, which is a fixed-dose of the i n h a l e d c o r t i c o s t e r o i d ( I C S ) budesonide, the long-acting musca- rinic antagonist (LAMA) glycopyr- r o n i u m , a n d t h e l o n g - a c t i n g beta 2 -agonist (LABA) formoterol fumarate delivered via a pressurized metered dose inhaler, achieved the majority of primary and secondary targets in the Phase III KRONOS trial. PT010 demonstrated a statis- tically significant improvement ver- sus dual combination therapies in six out of seven lung function pri- mary endpoints in patients with moderate to very severe chronic forms of COPD. Regulatory sub- missions are expected in Japan and China in the second half of 2018, followed by potential submissions in the US and Europe in 2019. Novartis Ultibro ® Breez haler ® improves cardiac function in COPD patients with lung hyperinflation B A S E L , S W I T Z E R L A N D — Novartis has announced publica- tion of its CLAIM study in Lancet Respiratory Medicine, demonstrat- ing that once-daily treatment with the Ultibro ® Breezhaler ® (inda- caterol/glycopyrronium 110/50 mcg) significantly improved lung and cardiac function after 14 days of treatment, compared to placebo, in chronic obstructive pulmonary disease (COPD) patients with lung hyperinflation. e study is the first to investigate the effects of dual bronchodilation on cardiac func- tion and lung hyperinflation, which can occur as a result of air-trapping due to airway obstruc- tion. Lung hyperinflation has been linked to impaired cardiac function and worsening of COPD symp- toms, especially breathlessness (dyspnea). Ultibro Breezhaler is currently approved for use in over 100 countries worldwide. respIratory MedIcIne news Asthma attacks decline in US children A T L A N T A , G E O R G I A — According to Healio, a report pub- lished by researchers from the United States Centers for Disease Control and Prevention (CDC) showed that fewer US children are having asthma attacks in recent years. e number of children with asthma who had one or more attacks in the past year dropped from nearly 62 percent in 2001 to approximately 54 percent in 2016. The decline was seen in boys and girls and across all ages and ethnic groups. That translates into fewer missed school days and hospital vis- its, researchers noted. The report w a s b a s e d o n d a t a f r o m t h e National Health Interview Survey from 2001 to 2016. CDC's acting director, Dr. Anne Schuchat, said she believes that the decline in asthma attacks is due, at least in part, to better-educated children and parents, and to community efforts that focus on high-risk chil- dren. However, Schuchat noted that not all of the news is good. In 2016, about half of all children with asthma had at least one attack, and one in six children went to the emergency department or an urgent care center. Moreover, the recent decline began after a steady increase. The prevalence of asthma in chil- dren grew between 2001 and 2010, but fell from 2010 to 2016. She also explained that more work is needed. "Although the decline signifies a step in the right direction, we know that children need to use medicine as prescribed to prevent asthma attacks, but our data show that about half of children prescribed asthma control medicine[s] do not use them regularly," she said. 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