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ADVANCE Perspective: Respiratory Views

Study: Omega-3 Fatty Acids May Reduce Asthma Risk in Children
December 29, 2016 1:41 PM by ADVANCE for Respiratory Care & Sleep Medicine

By ADVANCE Perspectives

 

According to a study published in The New England Journal of Medicine, researchers have found taking certain omega-3 fatty acids during pregnancy reduces the risk of the child developing asthma by nearly one-third.

 

The study from the Copenhagen Prospective Studies on Asthma in Childhood, or COPSAC, and the University of Waterloo, found that women who were prescribed 2.4 grams of long-chain omega-3 fatty acids during the third trimester of pregnancy reduced the risk of their child developing the disease by 31%.

 

Long-chain omega-3 fatty acids — eicosapentaenoic acid, or EPA, and docosahexaenoic acid, or DHA — are found in cold-water fish and help regulate the body's immune response.

 

"We've long suspected there was a link between the anti-inflammatory properties of long-chain omega-3 fats, the low intakes of omega-3 in Western diets and the rising rates of childhood asthma," Professor Hans Bisgaard of COPSAC at Copenhagen University Hospital said in a press release. "This study proves that they are definitively and significantly related."

 

University of Waterloo researchers used rapid analytical techniques to measure levels of EPA and DHA in the women's blood.

 

Researchers analyzed blood samples of 695 Danish women at 24 weeks' gestation and 1 week after delivery. The team then followed the health status of each child for 5 years.

 

The research showed that women with low blood levels of EPA and DHA at the beginning of the study benefitted the most from the supplements by reducing their children's risk of developing asthma by 54%.

 

"The proportion of women with low EPA and DHA in their blood is even higher in Canada and the United States as compared with Denmark," Professor Ken Stark, Canada Research Chair in Nutritional Lipidomics and professor in the Faculty of Applied Health Sciences in Waterloo and study author, said in a press release. "So, we would expect an even greater reduction in risk among North American populations. Identifying these women and providing them with supplements should be considered a front-line defense to reduce and prevent childhood asthma."

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A Trial of Clinical Trials
December 2, 2016 12:26 PM by ADVANCE for Respiratory Care & Sleep Medicine

By Sarah Sutherland

 

Exciting news for clinical trial researchers! The days of spending more time figuring out how to use your electronic data capture (EDC) — rather than actually conducting research — could be troubles of the past. Recently, Porter Research, an independent firm based in Atlanta, determined that OmniComm Systems, Inc. received the highest grades for their TrialMaster EDC from clinical trial researchers around the globe.

 

For the survey, clinical trial researchers were asked to select their preferred EDC system based on their experience and EDC usage over the past 2 years. Additionally, they rated EDC systems based on ease of use, performance and customer support — all categories for which the TrialMaster EDC exceeded the average rating.

 

“We are delighted to have the site survey confirm what we have been hearing anecdotally for years — namely, that the site investigators really prefer our EDC system,” said Kuno van der Post, senior vice president of business development at OmniComm. “We were actually surprised to see that almost three out of five sites preferred the TrialMaster EDC over the presumptive market leader. Notably, our customer service and support are recognized as far superior to our larger competitors, based on the survey results. Again, this is great validation of our position in the current market as the EDC specialist.”

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The survey indicated that researchers choose EDC systems — including the TrialMaster EDC — based on:

 

1.    Ease of data entry

2.    Simple login and navigation

3.    Overall user-system familiarity

4.    User-friendliness

5.    Easy-to-answer queries

 

So, researchers, we want to know: What makes you love your EDC system? How can EDC systems still be improved? What would make you switch to another system? Let us know in the comments below.

 

To learn more about OmniComm and the TrialMaster EDC, visit omnicomm.com.

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ResMed Launches AirView Action Groups
November 14, 2016 10:54 AM by ADVANCE for Respiratory Care & Sleep Medicine

ResMed has announced two enhancements to AirView, the world’s largest cloud-based remote patient monitoring platform that enables care teams to securely access therapy data from three million sleep apnea and respiratory care patients every day.

AirView Action Groups automatically filters a clinician’s sleep apnea patients on positive airway pressure (PAP) therapy into actionable groups based on adherence status or a specific therapy issue they may be having. This new “manage by exception” feature will reduce the time clinicians spend on back-office paperwork and processes, and will help ensure that patients get the most responsive and quality treatment.

In addition, when home medical equipment (HME) and other healthcare providers are required to prove a patient’s adherence before receiving reimbursement, they can now do so with greater efficiency. Action Groups are based on a similar feature in U-Sleep – another ResMed monitoring tool – that reduced clinicians’ patient management time by 59%.

AirView for Astral is now widely available, giving physicians and HME providers access to key data from their high-acuity or life support ventilator patients in ResMed’s secure cloud network. Clinicians can access their patient data in AirView or through the ResMed Data Exchange where they can integrate their system’s electronic health records with AirView.

“Cloud connectivity is a major factor in the future of healthcare, but it’s not enough,” said Raj Sodhi, president of ResMed’s healthcare informatics business unit. “With the launch of AirView Action Groups, and AirView for Astral now available worldwide, we’re not only creating the connections and securely delivering the data to clinicians, we are providing them with the very specific and timely information they need about their patients – how they want it, when they want it and where they want it. ResMed’s pioneering innovations in this area will continue to positively impact patient outcomes and providers’ business efficiencies.”

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“The Action Groups make us incredibly more efficient,” said Stephanie Gersten, president and owner of CPAP Success, a San Francisco Bay Area-based HME provider. “Our staff got back all the hours they used to spend identifying which patients need what kind of support. Now they just pick a therapy issue, click that Action Group to see who has that issue, and go from there.”

“Cloud-connected ventilators means my staff can serve more patients, and also give them and their families greater peace of mind,” said Chris Masek, RRT, mechanical ventilator coordinator at Kubat Pharmacy in Omaha, NE. “There’s a unique security that comes with Astral, knowing that a clinician can see what’s happening with therapy miles away with the click of a button.”

ResMed plans to make the AirFit F20 and N20 masks available in the United States later this year (subject to clearance by the U.S. Food and Drug Administration). Both masks are currently being rolled out in Europe, the Middle East, Africa and Asia-Pacific.

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Spyryx Biosciences Presents Data on SPX-101
November 4, 2016 8:48 AM by ADVANCE for Respiratory Care & Sleep Medicine

By Tamer Abouras

 

There is big news pertaining to Cystic Fibrosis (CF) coming out of the 2016 North American Cystic Fibrosis Conference (NACFC), where three posters presented by Spyryx Biosciences provided data demonstrating the safety, stability and efficacy of SPX-101 in animal models and supporting further clinical development, according to a press release from the company.

 

SPX-101 is a SPLUNC1-derived peptide which restores a pathway (dysfunctional in patients with CF) in the human lung. It plays a key role in regulating airway surface liquid and mucociliary clearance, especially for patients with CF, who have difficulty clearing mucus from their lungs. This dysfunction causes CF patients to be prone to frequent chest infections, leading to progressive and irreversible damage.

 

“We are excited to share these positive results with the community of researchers and physicians who are all dedicated to finding breakthrough treatments for cystic fibrosis,” said John Taylor, president and CEO of Spyryx Biosciences. “We believe that SPX-101 represents the first therapeutic opportunity to leverage a natural, biological mechanism that is important to the maintenance of normal mucus clearance, with the potential to provide meaningful clinical benefit to all CF patients, regardless of mutation.”

 

A few highlights summarizing Spyryx’s findings in relation to SPX-101 include:

 

·         SPX-101 is a potent promoter of ENaC internalization, capable of regulating mucus hydration in vitro and in vivo

 

·         The scale-up and productization of SPX-101 for preclinical inhaled toxicology

 

·         SPX-101 demonstrates safety as an ENaC-affecting therapy for the treatment of cystic fibrosis

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Further summarizing the posters, the release stated that, “In GLP toxicology studies in two species, daily inhalation of SPX-101 at delivered doses up to 19.6 mg/kg/day for 28 days, no SPX-101 related systemic or local respiratory tract toxicity or adverse clinical signs were observed. No SPX-101 related effects on body weights, food consumption, urinalysis, blood chemistry, or circulating electrolytes were observed. Importantly, SPX-101 did not increase serum potassium levels in these studies, demonstrating the potential of inhaled SPX-101 to improve outcomes for CF patients with a favorable safety profile. Given the doses administered, these findings provide adequate safety margins for the proposed clinical development plan.”

 

“These studies provide important data demonstrating low toxicity and supporting the proposed clinical doses, with no dose-limiting toxicity in the lung or systemically, and with no significant systemic bioavailability,” said Alistair Wheeler, MD, chief medical officer at Spyryx. “We believe these non-clinical data, combined with the exciting results from the single-ascending dose portion of our Phase 1 safety study, and the pending data from the multiple-ascending dose portion of the Phase 1, supports our intention to move forward with early entry into the clinic in our Phase 2 clinical development plan.”

 

For more information regarding Spyryx Biosciences and SPX-101, visit spyryxbio.com

 

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Data from Phase 1 Trial of Triplex Vaccine for Control of Cytomegalovirus Published in Blood
October 28, 2016 11:51 AM by ADVANCE for Respiratory Care & Sleep Medicine

By ADVANCE Perspectives

 

Duarte, CA and New York, NY — City of Hope and Helocyte, Inc., a majority-owned subsidiary of Fortress Biotech, Inc. has announced that data from the Phase 1 trial of Helocyte’s Triplex vaccine were published online this month in Blood, the journal of the American Society of Hematology. The vaccine is initially being developed for control of cytomegalovirus (CMV) in allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients. In the Phase 1 study, Triplex was found to be safe, well-tolerated and highly immunogenic when administered to healthy volunteers at multiple dose levels. These data supported the initiation of an ongoing Phase 2 trial evaluating Triplex in patients undergoing allogeneic HSCT.

 

In the Phase 1 trial, City of Hope researchers studied the response to the vaccine in 24 healthy volunteers. They found that Triplex generated robust and durable virus-specific immunity in those previously infected with CMV (addressing patients at greatest risk of viral complications following allogeneic HSCT) as well as in those with no prior CMV infection (addressing patients at greatest risk of viral complications following SOT).

 

CMV can impede the recovery of patients undergoing HSCT for the treatment for certain blood or bone marrow cancers. The virus can be transmitted to seronegative transplant recipients through infected donor grafts, or reactivated in seropositive transplant recipients (particularly those with low baseline immunity) as a result of their immuno-suppressed condition. In either instance, CMV can cause severe and life-threatening complications, including pneumonia, gastroenteritis and retinitis. Triplex has the potential to benefit patients in numerous clinical settings since the immune response generated by most individuals to CMV is far greater than the response associated with any other virus or condition.

 

“After years of work, it is very gratifying that we are making advancements in helping people worldwide achieve better health outcomes after a transplant procedure,” said Don J. Diamond, PhD, chair of the Department of Experimental Therapeutics at City of Hope, who led the team that developed Triplex. “Furthermore, Triplex’s favorable safety and immunogenicity may make the vaccine an ideal therapeutic platform to combat significant complications in many disease areas, like solid organ transplant and glioblastoma,” Diamond said.

 

“We are pleased to announce the publication of these important data in Blood. CMV is a ubiquitous virus that causes life-threatening disease in those with weakened immune systems,” said Frank Taffy, co-founder, president, CEO and board member of Helocyte. “We look forward to a continued collaboration with City of Hope as we advance our ongoing Phase 2 in HSCT, and initiate studies of Triplex across multiple other indications,” said Mr. Taffy.

 

John A. Zaia, MD, director of City of Hope’s Center for Gene Therapy and the Aaron D. Miller and Edith Miller Chair in Gene Therapy, served as the Phase 1 trial’s principal investigator.

 

Research reported in the aforementioned Blood publication was supported by the National Cancer Institute of the National Institutes of Health.

 

For more information, please visit http://www.helocyte.com/ and http://www.fortressbiotech.com/.

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BD and Vancive Medical Technologies Launch New Vascular Dressings with CHG Antimicrobial
September 16, 2016 12:43 PM by ADVANCE for Respiratory Care & Sleep Medicine

By ADVANCE Perspectives

 

Big news from BD! The company, along with Vancive Medical Technologies, has launched a line of transparent vascular dressings with chlorhexidine gluconate (CHG) antimicrobial preservative that are designed to enhance patient care and be easy for clinicians to apply and remove. This comes as welcome news to patients receiving long-term care for their vascular conditions.

 

The new BD ChloraShield dressings, which feature the innovative adhesive BeneHold CHG technology developed by Vancive Medical Technologies, comfortably secure the dressing to the skin, absorb fluids and protect the site from external contaminants. The CHG incorporated within the adhesive preserves the dressing from microbial growth, making them well-suited for catheter insertion sites. The Infusion Nurses Society recently released guidelines recommending the use of CHG dressings. BD is the exclusive distributor of the dressings worldwide.

 

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 "The combination of vascular access expertise from BD, infection prevention expertise from the CareFusion acquisition and CHG adhesive technology from Vancive Medical Technologies creates a powerful combination for a new vascular access product," said Stephen Hartley, global vice president of Infection Prevention for BD. "The new ChloraShield IV dressings complete BD's portfolio to offer a comprehensive set of products for vascular access procedures, including skin prep, catheters, connectors and flush products."

 

BD ChloraShield dressings are available in a variety of designs including bordered and non-bordered as well as sizes commonly used for peripheral IVs and PICCs.

 

"BeneHold CHG adhesive technology is well-suited for vascular access dressings," said Kirsten Newquist general manager for Vancive Medical Technologies. "The collaboration with BD brings together complementary expertise from both companies and we look forward to expanding the product offerings in the future."

 

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BD and Vancive Medical Technologies will showcase the new BD ChloraShield dressings in booth #423 at the 30th annual Association for Vascular Access Conference, being held September 16–19 in Orlando, Florida.

 

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Philips Announces Sponsorship of COPD Documentary
September 2, 2016 7:52 AM by ADVANCE for Respiratory Care & Sleep Medicine

By Tamer Abouras

 

Live long and prosper! Royal Philips has announced its sponsorship of the documentary, “COPD: Highly Illogical - Remembering Leonard Nimoy.” The documentary seeks to educate viewers about chronic obstructive pulmonary disease (or COPD) through Leonard Nimoy’s courageous personal story, while also providing the latest information about treatments for the disease.

 

Complex respiratory illnesses including asthma and COPD are on the rise, with COPD estimated to affect 24 million adults and more than half not knowing they have the illness despite exhibiting symptoms. In the United States alone, 120,000 people die from COPD each year and with more than three million deaths annually, COPD is expected to be the third leading cause of death worldwide in the next 15 years, exceeding breast cancer, colorectal cancer and prostate cancer combined, according to the World Health Organization.

 

“COPD claims millions of lives every year, yet it doesn’t have nearly as much visibility as it should for how difficult it makes the lives of patients and their families. Our aim in sponsoring this film is to raise awareness of the disease and its consequences if left undiagnosed or untreated,” said Eli Diacopoulos, home respiratory care business leader, Philips. “By sponsoring this film, we hope to spark conversations about improving COPD detection, prevention and treatment, and empower people with facts to educate others about a disease that has profoundly impacted many lives, like Leonard Nimoy’s.”

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Produced by Nimoy’s daughter, Julie Nimoy, and her husband, David Knight of Health Point Productions, “COPD: Highly Illogical” reveals the last few months of the famed actor’s life, which was claimed by the disease in February 2015. Nimoy’s COPD stemmed from both his smoking addiction and the fact that his decade-long struggle with the disease was not officially diagnosed until 2013, when it had progressed past the point of effective treatment.

 

“Movie enthusiasts and science fiction fans alike were captivated by my father, Leonard Nimoy, in his role as Mr. Spock in Star Trek,” said Julie Nimoy. “His character’s iconic catchphrase, ‘Live long and prosper,’ quickly echoed through generations and became a battle cry for fans. I look forward to continuing my dad’s mission of raising awareness and helping COPD patients like him to live longer and prosper in their own lives, as my dad did in his.”

 

ADVANCE Opinion Poll: What is the biggest reason for patient non-compliance with CPAP?

 

Philips will showcase its latest COPD and respiratory solutions at the upcoming European Respiratory Society International Congress (ERS) in London, from September 3–7. Further details on the production of “COPD: Highly Illogical - Remembering Leonard Nimoy” will also be available.

 

To learn more about the documentary and view the trailer, please visit http://copdllap.com. For more information on Philips Sleep & Respiratory Care, visit http://www.usa.philips.com/healthcare/solutions/sleep-and-respiratory-care.

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ECMO Market Size Projected to Reach $346.1 Million by 2024
August 18, 2016 9:14 AM by ADVANCE for Respiratory Care & Sleep Medicine

By ADVANCE Perspectives

 

The extracorporeal membrane oxygenation market is expected to reach $346.1 million by 2024, according to a new report by Grand View Research, Inc. The growing number of respiratory failure cases and conditions, such as cardiopulmonary disease and Chronic Obstructive Pulmonary Disease (COPD) is anticipated to boost the market growth. According to the U.S. National Center for Health Statistics, in the year 2014, there were about 149,205 deaths due to chronic lower respiratory disorders in the U.S.

 

Moreover, the increased adoption of ECMO machines in hospitals as a consequence of the medical community taking cognizance of the advantages related to the use of ECMO machines is anticipated to facilitate the emergence of this market during the forecast period.

 

Apart from the high applicability of these appliances in hospitals, technological advancements have played a pivotal role in further accelerating the usage of these devices. Medtronic's Century heart lung machine, for instance, consists of an arterial pump, data management system and cardioplegia delivery system, and is employed to provide cardiopulmonary functional support to patients.

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Further key findings from the study suggest:

 

  • The veno-venous segment held a lucrative share in 2015 among the modality types owing to its efficiency and reliability in furnishing gas exchange support.
  • The respiratory application segment held a remunerative share in 2015; this is attributed to the increasing number of patients suffering from respiratory conditions. Moreover, the technological advancement in the ECMO machines has further increased its adoption rate in hospitals for its use in respiratory failure conditions.
  • North America dominated the overall market with a revenue share of over 40% in 2015, owing to the presence of a well-developed infrastructure and a suitable reimbursement framework as well as the rise in number of supportive government funds.
  • Asia Pacific is anticipated to be the fastest growing region with a CAGR of about 5 % over the forecast period. Notable economic developments and the advancing healthcare system developed with the aid of supportive government initiatives are anticipated to assist the growth.
  • Rising incidences of respiratory failure and cardiopulmonary diseases are identified as major impact rendering factors for the growth of this market. According to the World Health Organization, about 3 million deaths were reported globally due to COPD in the year 2012, which accounts for 6% of the total mortality.
  • Some leading players in this vertical include Maquet Holding B. V. & Co.KG, Microport Scientific Corporation, Medos Medizintechnik AG, Sorin Group, Medtronic Plc, Terumo Cardiovascular Systems Corporation and Nipro Medical Corporation.
  • These key players opt for technologically enhanced products and undertake collaborations with other companies to implement new product development strategy goals to sustain a competitive advantage in the industry.

ADVANCE Opinion Poll: What is the biggest reason for patient non-compliance with CPAP?

[Source: PRNewswire]

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Q&A with Eli Diacopoulos from Philips Respironics
August 4, 2016 9:31 AM by ADVANCE for Respiratory Care & Sleep Medicine

By Tamer Abouras

 

Philips Respironics recently announced exciting news about their SimplyGo Mini portable oxygen concentrator, which now conforms to all applicable Federal Aviation Administration (FAA) requirements for in-flight use.

 

ADVANCE had the opportunity to catch-up with Eli Diacopoulos, a business leader at Philips Home Respiratory Care, about this development and the SimplyGo Mini product.

 

ADVANCE: Congratulations on the SimplyGo Mini conforming to all FAA requirements for POC carriage and in-flight use on board aircraft! Can you briefly touch upon the process of making this product available? Was it a long time coming securing FAA approval?

Diacopoulos: Thank you, we’re very excited about the news. In May of this year, the FAA published new rules for authorizing POC use on board aircraft in air carrier operations, commercial operations and certain other operations using large aircraft. In the past, manufacturers needed to submit each individual device for approval by the FAA. As of May, the FAA put forth standards for manufacturers to conform to. Each manufacturer is responsible for making sure that their devices conform to the standards and then labels the device as such. SimplyGo Mini’s approval, however, was submitted during the time when the FAA was in the midst of changing this ruling, so it took 12 months to finalize — longer than we originally anticipated.

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ADVANCE: Seguing off of that first question, what was the inspiration for developing the SimplyGo Mini? Did Philips compile data on the percentage of its customers who were in need of a product like the SimplyGo Mini? And if so, how great was the demand and how many fliers will this device be able to assist?

Diacopoulos: Patients are really driving the demand for smaller, lighter weight portable oxygen solutions that give them the autonomy and discretion to be active outside of their homes while on oxygen therapy. The inspiration behind SimplyGo Mini was the need to provide those patients with more freedom and confidence. With the combination of oxygen delivery and battery performance in a small, lightweight package and robust and reliable design, SimplyGo Mini delivers on patients’ and customers’ needs.

 

ADVANCE: To what degree was mobility and flying a major obstacle for patients with respiratory needs prior to the availability and FAA approval of the SimplyGo Mini?

Diacopoulos: Given that one driver for maintaining COPD patient health is physical routine, most clinicians want to allow their patients to continue living their lives as they did before their diagnosis. While SimplyGo Mini is not the first device to be approved for in-flight travel, it provides patients with a lightweight option and reliable therapy on-the-go. At only five pounds, SimplyGo Mini allows patients to be confident in their travels with oxygen on hand, without the concerns of more cumbersome devices.

 

ADVANCE: Is the SimplyGo Mini easy to maintain and keep clean? Especially given that it is geared toward those who travel frequently, is it something that can be cleaned (or given maintenance, if need be) while someone is on the go or perhaps in a hotel room?

Diacopoulos: The SimplyGo Mini requires no preventative maintenance by the patient. The SimplyGo Mini includes a stylish carrying bag that maintains cleanliness of plastic enclosure. Should the carrying bag need cleaning, it may be cleaned with mild soap and water.

 

ADVANCE Opinion Poll: What is the biggest reason for patient non-compliance with CPAP?

 

ADVANCE: Finally, being a small and portable device, how often does the SimplyGo Mini need its oxygen supply replenished? Is this also convenient and easy for a frequent flier to take care of?

Diacopoulos: One of the great things about SimplyGo Mini is that it is a portable oxygen concentrator that runs on AC/DC power. That means that it doesn’t run out of oxygen or need to be replenished like old fashioned tanks that most people are familiar with. It takes oxygen from the air and concentrates it, running up to 4.5 hours on a standard battery or 9 hours on an extended battery. Most airlines suggest that patients bring enough battery power equal to or greater than 1.5 times the expected length of the flight.

 

For more information, visit usa.philips.com.

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Philips' Care Orchestrator to Connect Trilogy Ventilators for Patients with COPD
July 21, 2016 2:01 PM by ADVANCE for Respiratory Care & Sleep Medicine

By ADVANCE Perspectives

 

From PRNewswire, some exciting news about portable ventilation from Philips Respironics. 

 

Philips Respironics has announced that its Trilogy family of portable ventilators, the most widely used ventilators in North America, will be activated to connect to the Care Orchestrator care management application. With complex respiratory illnesses including neuromuscular disorders and COPD on the rise in the U.S., this respiratory care service will enable enhanced care for patients in the home.

 

Care Orchestrator is a connected health application in the homecare space that connects clinical management workflow, informatics and intelligence for providers, payers and patients within a single cloud-based platform. Once operational later in 2016, Care Orchestrator will interact with Philips' sleep and respiratory devices, electronic medical records (EMRs), insurance claims and billing systems and other Philips and third party applications on the Philips HealthSuite Digital Platform.

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"Enabling cloud connectivity of Philips' Trilogy ventilation line is an important step toward our larger ambition to commercialize a respiratory care management service that enables better health and better care at a lower cost," said Eli Diacopoulos, respiratory care business leader, Philips Respironics. "Philips wants to empower the homecare community to work as one with the patient, enabling increased possibilities in remote patient monitoring and enhanced care from the hospital to the home."

 

Trilogy ventilators, introduced in 2008, have continued to advance in clinical effectiveness, evolving with features focused on enhancing the patient experience, including therapy algorithms like AVAPs-AE and Mouth Piece Ventilation mode. With a focus on reducing hospitalizations and improving clinical outcomes, Philips has distributed connectivity-ready Trilogy ventilators in North America since 2015 in preparation for the Care Orchestrator launch. Homecare providers will be able to connect thousands of Trilogy ventilators already in market though a simple update once Care Orchestrator is launched later in 2016.

 

ADVANCE Opinion Poll: What is the biggest reason for patient non-compliance with CPAP?

 

In addition to connecting Trilogy ventilators, Philips will also connect its EverFlo and SimplyGo oxygen concentrators, as well as the iNeb respiratory drug delivery device to Care Orchestrator. With oxygen and respiratory drug delivery devices added to its line of connected solutions, Philips will have the most comprehensive connected respiratory care portfolio in the homecare industry. 

 

For more information, visit usa.philips.com.

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New Opioid Use Among Older Adults with COPD Linked to Increased Risk for Respiratory-Related Death
July 14, 2016 1:18 PM by ADVANCE for Respiratory Care & Sleep Medicine

By Tamer Abouras

 

(News-Medical.net) — Older adults with chronic obstructive pulmonary disease who start using opioids have a more than two-fold higher risk of dying from a respiratory-related complication compared to non-opioid users, St. Michael's Hospital researchers have found.

 

When researchers looked specifically at more potent opioids, they found the risk for respiratory-related death was five times higher for new opioid users compared to non-opioid users.

 

The study, published today in the European Respiratory Journal, raises safety concerns about new opioid use among older adults with chronic obstructive pulmonary disease, or COPD, a progressive lung disease that causes breathing difficulty, said Nicholas Vozoris, MHSc, MD, FRCPC,  a respirologist at St. Michael's and lead author of the study.

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COPD affects approximately four to 10 per cent of the Canadian population, with the five-year mortality rate from 40 to 70 per cent, depending on the severity. The two-year mortality rate for people with severe COPD is about 50 per cent.

 

The researchers looked at the records of more than 130,000 adults in Ontario age 66 and older with COPD, using multiple provincial health care administrative databases at the Institute for Clinical Evaluative Sciences.

 

"Previous research has shown about three-quarters of older adults with COPD have been prescribed opioids, which is an incredibly high rate of new use in a population that is potentially more sensitive to narcotics," said Vozoris. "Our new findings show there are not only increased risks for respiratory-related death associated with new opioid use, but also increased risk, of visits to emergency rooms, hospitalizations and needing antibiotics or steroid pills."

 

Vozoris found that 68 per cent of older adults with COPD living in the community were given a new opioid prescription between April 2007 and March 2012. Opioids, such as codeine, oxycodone and morphine are prescribed frequently among older adults with COPD to help treat chronic muscle and bone pain, persisting cough and shortness of breath despite inhaler therapy, as well as insomnia.

 

"This is a population that has a chronic lung disease, with symptoms that can sometimes be challenging to manage," said Vozoris. "This class of drugs may offer some relief, however, there is also evidence suggesting that opioids can adversely affect breathing and lung health in people who already have chronically compromised lungs."

 

To lower the risks of adverse events in this population, the thinking has been to prescribe less potent or lower dosage opioids. However, Vozoris and his team still found a significantly increased risk of respiratory-related complications and death in new opioid users, regardless of dose. "This is an important finding because it has been previously thought that lower opioid doses might be safe for COPD patients," said Vozoris.

 

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Vozoris hopes that clinicians take these findings into consideration when prescribing opioids to COPD patients. Current guidelines recommend their use to manage difficult-to-control respiratory symptoms that can often compromise a patient's quality of life, but current evidence does not support the use of opioids for chronic pain.

 

"Sometimes patients are looking for a quick fix for chronic pain or breathing issues and physicians may believe opioids can offer them some relief," said Vozoris. "The trade-off becomes explaining that there are risks to patients and making sure they understand that potentially alleviating their symptoms could come at a higher cost to their health."

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Potential Respiratory Syncytial Virus Vaccine on the Way from Vaxart
June 30, 2016 2:02 PM by ADVANCE for Respiratory Care & Sleep Medicine

By Tamer Abouras

 

ADVANCE has covered respiratory syncytial virus (RSV) consistently in the past year. Any why wouldn’t we? RSV is a major cause of severe respiratory infection in the elderly, in immunocompromised patients and in adults with other underlying medical conditions, and is the most common cause of acute lower respiratory infection in infants and young children.

 

Moreover, according to the Centers for Disease Control and Prevention (CDC), RSV causes 177,000 hospitalizations and 14,000 deaths among adults older than 65 in the United States each year and as of now, there are no U.S. Food and Drug Administration (FDA) approved RSV vaccines available.

 

All of that may be poised to change, however, thanks to Vaxart’s new initiation of a Phase 1 clinical trial of the first oral respiratory syncytial virus (RSV) tablet vaccine. Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines administered via tablet rather than injection.

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“The start of the RSV Phase 1 study is a significant milestone for Vaxart’s oral vaccine platform,” said Wouter Latour, MD, CEO of Vaxart. “We previously demonstrated that our oral H1N1 influenza tablet vaccine has the potential to outperform commercially available flu vaccines. Now, we are entering the clinic with an oral RSV tablet vaccine based on the same platform. This establishes Vaxart as a leading innovator in the respiratory vaccines space, and we look forward to the results of this study with great anticipation.”

 

“In preclinical studies, our RSV vaccine generated robust immune responses and provided complete protection against infection,” added David Liebowitz, MD, PhD, and chief medical officer of Vaxart. “RSV is an important public health indication and we believe a tablet vaccine would be ideal for immunizing large populations, especially the elderly and at-risk adults where RSV causes considerable disease and mortality.”

 

According to a press release put out by Vaxart, “The randomized, double-blind, placebo-controlled Phase 1 dose-ranging study will assess the safety and immunogenicity of Vaxart’s F-protein based RSV tablet vaccine in 66 healthy adult volunteers. Study participants will be followed for 12 months for safety, and a broad range of systemic and local immune responses will be evaluated at multiple time points over the study.”

 

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Incidences of RSV in the general population — regardless of age — are high enough that the development of this oral vaccine would stand as a landmark accomplishment in the fight against it. Here’s hoping Vaxart’s Phase 1 study is as successful as its preclinical studies.

 

For more information, please visit vaxart.com.

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GSK’s Triple-COPD Trial a Success
June 20, 2016 12:28 PM by ADVANCE for Respiratory Care & Sleep Medicine

By Tamer Abouras

 

From Digital Look, some exciting — and relieving news — for GlaxoSmithKline.

 

European and U.S. regulatory submissions are likely to be completed the end of 2016 based on the data from this Phase III clinical test by GSK and its regular respiratory project partner, Innoviva.

 

The study showed the combination of three COPD medicines delivered meaningful improvements in lung function and health-related quality of life compared to the dual therapy of budesonide/formoterol.

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Glaxo and Innoviva were testing their once-daily “closed” triple combination therapy of fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta agonist to treat patients with COPD in the 24-week “FULFIL” trial, standing for “lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy.”

 

The study met its two co-primary endpoints, demonstrating statistically significant improvements compared with a twice-daily dose from a Symbicort Turbohaler in both lung function as measured by the “trough FEV1” measure of lung capability and health-related quality of life as measured by the St. George's Respiratory Questionnaire at the end of the study period.

 

Safety of the treatment was at the end of the trial and the 52-week extension was consistent with the individual medicines and their combinations, with the most common adverse events being nasopharyngitis, headache and COPD worsening.

 

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"Triple combination therapy is already a reality for many patients with COPD and is dispensed in multiple inhalers," said GSK's head of respiratory R&D, Dave Allen. "By combining three medicines in a single inhaler we can offer a convenient, once-daily dosing option to patients while improving their symptoms."

 

NYSE-listed Innoviva has partnered with GSK on combination respiratory products including Relvar/Breo, Ellipta and Anoro Ellipta.

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Summer Fun at UPMC’s Heart Camp for Kids
June 9, 2016 12:47 PM by ADVANCE for Respiratory Care & Sleep Medicine

By Tamer Abouras

 

The Dr. Bill Neches Heart Camp for Kids, sponsored by Children’s Hospital of Pittsburgh of UPMC, offers children and adolescents with heart disease a summer camp experience. The camp gives children and adolescents with heart disease the chance to enjoy summer camp and a variety of activities during the week.

 

Back for its 26th year, more than 120 children 8 to 15 years old will travel to western Pennsylvania to enjoy camp activities such as swimming and hiking while sharing with each other the challenges of living with heart conditions. The camp was held June 14–18 at Camp Kon-O-Kwee in Fombell, Pennsylvania.

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The camp, established in 1991 by Children’s Hospital, is the first in the nation dedicated solely to children with heart disease. It’s named in honor of its founder and cardiologist William Neches, MD, who retired in 2005 after 33 years at Children’s Hospital.

 

“There is a special feeling among all of us who have participated in Heart Camp — campers, staff and caregivers alike,” said Neches. “Heart Camp has changed all of our lives for the better, and we look forward to many more years of these experiences.”

 

Heart disease affects approximately 1% of all children born in the United States, yet very few who have heart disease ever get to know others with the same problems. Each year, young people with heart conditions attend Heart Camp, make new friends and share their experiences.

 

Alissa Carter, a patient with the Heart Institute at Children’s Hospital who has attended as a camper and is now a senior counselor, said Heart Camp is a place of belonging.

 

“Heart Camp has always been about finding a place you belong, where you can be 100% yourself,” said Carter, 24. “I learned that I didn’t need be ashamed of my scars. I come back every year in the hope that I can change a camper’s life in the way my counselors and the staff here have changed mine over the years.”

 

Heart Camp provides an opportunity for children to spend time with their doctors and nurses in a non-medical setting. In this environment, campers learn to view the medical staff as friends, and the medical staff learns more about each child’s personality and limitations.

 

Heart Camp serves as a support system for Kelsey Hallinen, a senior counselor this summer.

 

“Without Heart Camp, I never would have met my best friends,” said Hallinen, 24. “Camp has provided a rock-solid support system that I know will help with whatever comes my way. As a counselor, I am continually inspired by my campers’ accomplishments and positivity. I can't wait to see what this year will bring and know, no matter what, it will be great.”

 

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Favorite activities include the Ask the Doctor/Nurse and Ask the Counselor sessions, which give campers the opportunity to find out more about the people caring for them and typical outdoor fun such as fishing and crafts.

 

In addition to many generous donors, Heart Camp receives support from organizations including the American Heart Association. The camp is a program of the Heart Institute at Children’s Hospital, which cares for infants, children and young adults with all types of heart disease and for adults with congenital heart disease, including many who have undergone heart transplants.

 

For more information on Heart Camp, visit chp.edu/heartcamp.

 

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Putting Peanut Allergies Back in Their Shell
May 27, 2016 8:23 AM by ADVANCE for Respiratory Care & Sleep Medicine

By Tamer Abouras

 

These days, it seems pretty common to have a friend or relative who unfortunately suffers from a peanut allergy, lactose intolerance or Celiac Disease. Off the top of my head, I can think of two cousins and several close friends who fit into some or all three of those classifications, seemingly resigned to live their entire lives without ever being able to enjoy a peanut butter and jelly sandwich with a glass of cold milk.

 

For my part, I have an allergy to shellfish, so I’ll never know what it’s like to crack open a crab or gobble up shrimp like chicken wings. And while it’s a misnomer to believe these allergies are a new phenomenon — we just happen to be more conscious of them and more equipped to detect them now — they’re nonetheless an unpleasant fact of life for many, oftentimes beginning in childhood.

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There is some emerging research, however, which suggests that allergies may be something we could eventually treat or cutoff altogether — provided they’re spotted and addressed early enough in life, before they have the chance to fully develop.

 

According to a press release from National Jewish Health, “Simultaneous pre-treatment with antihistamines that block both the H1 and H4 antihistamine receptors suppressed the gastrointestinal symptoms of food allergy in mice. The findings, published online in the journal Allergy, provide new insight into the development of food allergy and suggest potential therapies for prevention and treatment of food allergy.”

 

The release continued, saying, “Although recent findings have suggested that early exposure to peanuts can help prevent peanut allergy, the only effective therapy currently available for existing cases remains avoidance. Meiquin Wang, MD, PhD, Erwin Gelfand, MD, and their colleagues at National Jewish Health pretreated mice sensitized to peanut with the H1 receptor antagonist loratadine (Claritin), and the experimental H4 receptor antagonist JNJ7777120, separately and in combination.”

 

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As far as the results, they were promising.

 

“Separately, the two antihistamines had some effect on the intestinal response of the sensitized mice to peanut,” the report stated. “When mice were pre-treated with both antihistamines together, diarrhea, intestinal inflammation and other symptoms were almost completely blocked. In vitro experiments indicated that the antihistamines work by suppressing the accumulation and function of dendritic cells, which take up peanut protein and present it to T cells of the immune system.”

 

So perhaps there’s no hope for those aforementioned friends and family members who have never partaken of that classic American lunch. For their children, however, who might otherwise inherit their allergic reactions, this research may provide some hope.

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