FDA Approves Pulmozyme with eRapid Nebulizer

CF Patients See 2 – 3 Minute Treatment Times

The eRapid Nebulizer System (eRapid) from PARI has been approved as the first electronic nebulizer by the Food and Drug Administration to deliver Genentech’s Pulmozyme for cystic fibrosis treatment.? A huge improvement for cystic fibrosis patients, eRapid is able to reduce average treatment times with Pulmozyme from 6-8 minutes down to 2-3 minutes.? Both adult and pediatric patients showed a strong preference for eRapid over conventional nebulizers in a clinical study. FDA-Logo

“We have been pleased with eRapid’s fast treatment times in the lab and are excited that patients now have access to a much faster Pulmozyme therapy.? As the first electronic nebulizer to deliver Pulmozyme, eRapid is a true breakthrough for cystic fibrosis patients who take the therapy daily, often for years,”?said Lisa Cambridge, director of Medical Science and Pharmaceutical Alliances at PARI Respiratory Equipment, Inc.

“PARI was motivated to introduce eRapid to the US market based on encouragement from the Cystic Fibrosis Foundation and their input to have a general-use, electronic nebulizer that could improve therapy adherence. For many years, eRapid has been successfully distributed in Europe (as eFlow Rapid) with favorable feedback from patients with CF. In the Pulmozyme clinical trial, there was a 10:1 preference for eRapid in the pediatric group and a 20:1 preference in the adult group.? That confirmed our decision to bring eRapid to the US,” added Geoff A. Hunziker, president of PARI USA.

“After the successful results of a Phase IV study, we are confident that physicians will see that both pediatric and adult patients favor eRapid based on reduced treatment times, quiet operation, and its small, portable size.? We were also happy to see that patients were more satisfied with treatment and eRapid had a positive influence on adherence ? good for their overall cystic fibrosis management,” added Lisa Cambridge.? eRapid is available today by prescription through a select group of specialty pharmacies.? Visit www.pari.com or call 1-800-FAST-NEB to learn more.

Pulmozyme is indicated for daily administration along with standard therapies for the management of cystic fibrosis to improve pulmonary function.? For more information, visit http://www.pulmozyme.com/.

About eRapid Nebulizer System eRapid is an electronic nebulizer that enables quick and efficient inhalation that can greatly reduce a patient’s treatment burden. ?For more information on eRapid, please visit http://www.pari.com/.

About Cystic Fibrosis Cystic fibrosis, a life-threatening disease affecting 30,000 American patients, involves a genetic mutation that results in poorly hydrated, thickened mucus secretions in the lungs, as well as severely impaired mucociliary clearance.? Get more information about Cystic Fibrosis, visit http://www.cff.org

About PARI Respiratory Equipment, Inc. PARI is a leading, worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, cystic fibrosis, RSV, VAP, and HAP.? PARI’s worldwide vision is to improve the lives of those affected by respiratory diseases and those who care for them.?PARI is considered the gold standard for aerosol delivery for nebulizer therapies.? Featured products include the PARI LC PLUS Reusable Nebulizer, Vortex Holding Chamber, and the drug-specific eFlow Technology platform.

SOURCE: PARI Respiratory Equipment, Inc., Displayed with permission from PR Newswire via RePubHub

New Treatment Helps 80% Of Kids Overcome Peanut Allergies

In the past several decades, the number of children with peanut allergies has tripled from 0.4 percent in 1997 to 1.4 percent in 2010, according to a Mount Sinai Hospital study. While doctors aren?t certain what caused the increase, it has led schools and airlines to ban peanut products out of fear of causing severe reactions.

By Lecia Bushak? Release Date January 31, 2015

Now, a new study from Murdoch Children?s Research Institute outlines a new treatment that could possibly cure children of their peanut allergies. The researchers gave 60 peanut-allergic children a dose of a probiotic known as Lactobacillus rhamnosus (around 20 kilograms of yogurt) mixed with a peanut protein, and gradually increased the daily amount over the course of 18 months in order to test whether their tolerance would gradually increase. Over 80 percent of the children who received the treatment were no longer severely allergic to peanuts by the end of the 18 months, when compared to four percent of the placebo group.

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For the study, “the combined delivery of probiotic and oral immunotherapy was a safe and effective treatment for peanut allergy; however, it is important to point out that this treatment must be given only under close medical supervision as we are giving peanut to children who are allergic to peanut, and children did have allergic reactions,? said Professor Mimi Tang, an author of the study, in the press release. ?Nevertheless, the likelihood of success was high ? if nine children were given probiotic and peanut therapy, seven would benefit.?

Immunotherapy, more simply known as allergy shots, is a long-term treatment that helps people develop a higher tolerance to allergens, and decreases symptoms of allergic rhinitis, allergic asthma, or conjunctivitis, according to the American Academy of Allergy, Asthma, and Immunology (AAAAI). Allergy shots are similar to vaccines: The body responds to each injection by building up its immunity to the allergen, similar to how vaccines help the body create defenses against viruses.

Previous research has found that oral immunotherapy ? meaning doses of the allergen taken by mouth, not a jab ? proved useful in decreasing symptoms of peanut allergy in children. Also known as desensitization, the treatment is still being studied. Until it’s used more widely, most people with peanut allergies should still avoid peanuts at all costs, and carry an ?Epi-pen,? or a shot of epinephrine, wherever they go to prevent anaphylaxis. Less severe allergy cases involve Benadryl as the only treatment option.

The new study?s results, however, are promising. Eighty-two percent of the children treated with the probiotic mixture were able to include peanuts in their diet after the trial, compared to 3.6 percent of the placebo group. ?It appears that we have been able to modify the allergic response to peanut such that the immune system produces protective responses rather than a harmful response to the peanut protein,? Tang said.

The authors believe that finding a cure for peanut allergies is crucial, since it?s one of the most common and severe allergies ? it can also last a lifetime. Out of the 15 million Americans who have some form of food allergy, peanut, milk, and shellfish allergies are the most prevalent.

?Many of the children and families believe it has changed their lives, they?re very happy, they feel relieved,? Tang told The Guardian. ?These findings provide the first vital step toward developing a cure for peanut allergy and possibly other food allergies.?

Source: Tang M, Ponsonby A, Orsini F, Tey D, Robinson M, Su E. Administration of a probiotic with peanut oral immunotherapy: A randomized trial.?The Journal of Allergy and Clinical Immunology. 2015.

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If You Have Penicillin Allergies, You Should Get Retested

Patients who have been diagnosed with penicillin allergies probably aren?t allergic to it anymore, according to a new finding. The allergy wears off over time, but most people live the rest of their lives believing they’re still allergic, and pay for more expensive, unnecessary medication.

by Samantha Olson? Release Date: November 9, 2014

Mayo Clinic Allergist Dr. Thanai Pongdee, and his team retested 384 patients and found 94 percent of them were not allergic. The patients were scheduled to undergo several different types of surgeries when they were tested. Pongdee said he expected they would find maybe half of the patients still allergic to penicillin, a common medical allergy. However, when almost all of the patients found they weren?t allergic, it more than confirmed a suspicion doctors had for a long time.

Test Tube Penicillin
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“We knew that the majority of people who list penicillin as an allergy actually aren?t allergic when they are reevaluated, so if you can determine they are not, you can avoid using more toxic and more expensive antibiotics,” Pongdee told NBC News. “It doesn?t happen very often that a health care provider challenges the presumption that the patient is still allergic. Many don?t realize that this is something a person may lose over time.”

When a patient walks into the hospital, one of the first questions they?re asked is, “Are you allergic to any medications?” Ten percent of the population report they’re allergic to penicillin, making it the most commonly reported drug allergy, according to the American College of Allergy, Asthma & Immunology?(ACAAI). A patient with an allergy may develop hives, swelling, throat tightening, wheezing, coughing, and difficulty breathing. In severe cases, it can cause a patient to go into sudden anaphylactic shock, which will rapidly worsen and could become deadly.

Penicillin has been around since 1928, and has been used to treat a variety of conditions, such as strep throat, ear infection, or sinus infection. Penicillin is the base of many front-line drugs, and if you can?t take one of those, you?re often forced to take a more expensive alternative with more side effects.

When one Long Island mother, whose son was diagnosed with a penicillin allergy at the age of 8, was asked if she would have him retested, she said, “I definitely would. It would stop us from worrying because he doesn’t wear a bracelet. He broke out in a rash and hives after he was given amocycillin for his strep throat.”

In most cases their sensitivity to penicillin will lessen overtime and can be treated safely with the drug. It?s exciting news for patients with documented penicillin allergies because they can start receiving cheaper drugs, such as the generic penicillin-based amoxicillin used to fight bacterial infections. Most people are diagnosed when they are toddlers due to an adverse reaction, but then live the rest of their lives avoiding a drug allergy with unfounded fears.

?There are two issues: these patients are put on other antibiotics which [are] less effective and potentially have more side-effects,? Family Allergist Dr. James Sublett, the incoming president of the ACAAI told NBC News. ?The other is cost. A very commonly used substitute, for example Levaquin, is seven to eight times more expensive for a 10-day course than a similar course of generic Augmentin, a penicillin drug.?

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Clinical Trials Monthly Case Study Analysis


Each month, we take a look at a different Clinical Trial Case Study ? this month it?s a look inside an ALLERGY trial that focused on EXCEPTIONAL RESULTS:

The Scenario: Criterium provided an IVR patient diary solution to collect the pivotal efficacy data for an international clinical trial.

We asked ourselves😕 What if an after-the-fact paper patient diary could have been disastrous and could have necessitated the client repeating the study?

????????????? Because the estimated patient compliance rate was critical for the statistical analysis, Criterium daily monitored the patient diaries.

????????????? Through StudyControl?, Criterium designed reports to evaluate the compliance of each patient during the study. When patient compliance was less than predicted, Criterium informed the client immediately. This critical intervention enabled the sponsor to enroll additional patients into the study.

Additionally, daily management of the site by Criterium?s knowledgeable staff members helped ensure that patient compliance among the additional study participants was at the highest level, thereby meeting the study?s control requirements.

Our Result: The statistical analysis exceeded the client?s expectations.

Creative thinking in designing clinical trials upfront is always the ideal, but it?s important to remember that there are factors and variables that can?t be accounted for during planning.? When we look at trials, we look at all the factors that surround the potential issues facing a trial ? technology can be a great tool to keep trials running smooth, but it’s the human factor that allows the technology to be a reliable component of the work.

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Claire WyntersThu, 14 Mar 2013 16:21:00 GMT