Roche drug cuts asthma attacks, improves lung function -study

"Biological therapies" are the new frontier in asthma treatment, especially for patients with more severe disease. These antibody based medications provide a more targeted  strategy in asthma treatment compared to conventional asthma medications.  Dr. Susarla

Roche drug cuts asthma attacks, improves lung function -study

(Reuters) - An experimental drug reduced asthma attacks in patients with severe uncontrolled asthma by 60 percent and helped improve lung function in certain patients, indicating that the drug could offer the first personalized approach to treatment, according to data from a clinical trial released on Tuesday.

The biotech drug lebrikizumab, which was developed by Roche Holding's Genentech unit, was tested at three doses in patients whose asthma was not sufficiently controlled even with high-dose, inhaled corticosteroids and a second asthma-controlling therapy.

In the 463-patient Phase IIb study, lebrikizumab reduced asthma attacks by a statistically significant 60 percent more than a placebo in patients found to have a high level of the protein periostin, according to pooled data from the three doses tested - 37.5 milligrams, 125 mg and 250 mg. That compared with a 5 percent reduction versus placebo over 28 to 52 weeks of treatment in those with low levels of periostin.

"If this drug gets approved we would have for the first time a personalized approach other than just blanket therapy for everyone with uncontrolled disease," Dr Nicola Hanania, one of the study's lead investigators, said in a telephone interview.

Lebrikizumab works by blocking interleukin-13, or IL-13, which contributes to airway inflammation and mucous production. Periostin is believed to be a biomarker for IL-13 activity and a likely predictor of how well the Roche drug will work.

Roche is also developing a blood test for periostin in order to identify the patients most likely to benefit from lebrikizumab, which is injected once every four weeks.

Hanania, who is director of the Asthma Clinical Research Center at Baylor College of Medicine in Houston, called the data from the study "very exciting."

In those with severe asthma receiving existing treatments, "we still see patients who still have symptoms, who still have exacerbations, hospital admissions, and this is the type of patient this study was targeting," he said.

Curiously, the greatest level of asthma attack reduction, at 81 percent, was seen with the lowest dose of lebrikizumab, something that Hanania called surprising. Hanania, who presented the data at the American Academy of Allergy, Asthma and Immunology (AAAAI) meeting in San Diego, noted, "Higher is not always the better."

Fifteen percent of the estimated 25 million Americans with asthma suffer from severe asthma, according to the National Institutes of Health. About half of severe asthmatics are believed to have high periostin levels.

Among patients with high level periostin, the drug improved lung function by 9.1 percent after 12 weeks, compared with an improvement of just 2.6 percent in the low periostin group.

Lung function was tested by change in FEV1, a measure of the maximum amount of air that can be forcibly exhaled in one second. The greatest improvement in FEV1, of 10.7 percent, was seen with the 125 mg dose of lebrikizumab.

"Statistically it's significant, and I believe it is clinically significant because it goes hand in hand with reduction in exacerbations," Hanania said of the lung function improvement seen in the high periostin group.

The incidence of serious adverse side effects was low and similar in the lebrikizumab and placebo arms of the study, researchers said.

"The safety profile was very reassuring. Nothing really stood out as major side effect or major serious adverse effect," Hanania said.

If the results are replicated in large, ongoing Phase III trials that will include more than 2,000 patients, Roche said it expects to seek approval for the drug in 2016.

"As a clinician, this is important because there is a great need for additional therapy for those with poorly controlled asthma," Hanania said. "It's a light at the end of the tunnel."

Read article here.

Education is the Key to Better Asthma Management

It takes time to educate patients and parents about managing asthma.  The right asthma specialist can condense volumes of evidenced based literature and practice guidelines into  more easily understandable pearls that can be practical in our busy lives.  Dr. Susarla

What Are Some Strategies to Enhance Asthma Education in My Practice?

Primary-care offices are typically very busy places. As a result, the educational needs of parents and children with asthma often go unmet.¹Lack of time is a common reason reported for not providing asthma education in the primary-care setting.² However, providing asthma care consistent with the National Asthma Education and Prevention ProgramExpert Panel Report 3 (NAEPP EPR-3) Guidelines for the Diagnosis and Management of Asthma, which includes self-management education, does not have to be time consuming. One study evaluated the effects on patients 2 years after pediatricians were taught by their peers to enhance their skills in asthma therapies and counseling. This study found that pediatricians who participated in the training benefited in important ways. Trained physicians received higher patient-rated performance scores regarding communication behaviors important to promoting patient’s satisfaction and ability to manage asthma on their own, and in addition, their patients were also less likely to incur disruption of sleep caused by asthma symptoms. Another important finding of this study was that these positive results were achieved even though there was no difference in the time that peer-trained physicians spent with their asthma patients when first diagnosing a patient, seeing a new patient, or seeing a return patient. In fact, the peer-trained physicians spent less time with patients during urgent visits.³ Such a method for enhancing education in your practice requires changing physician behavior.

System-level changes have also been evaluated. In one such study, researchers evaluated the effectiveness of 2 asthma-care improvement strategies in the primary-care setting. One was less time consuming and less expensive and consisted of peer leader education. The other was more intensive and more expensive and consisted of allocating a nurse to conduct planned asthma-care visits. This group also received peer education. Findings revealed that, although both strategies decreased asthma symptom days, the peer leader group did not reach statistical significance.⁴ Therefore, when attempting to enhance educational practices in your office, it may be more effective to institute changes that target systems-oriented improvements, for example, developing a system that ensures all patients with asthma receive a written asthma action plan as per NAEPP EPR-3 Guidelines. One way to accomplish this is to automate the process by using an electronic medical record system. Such an approach makes it easy for the provider, legible for the patient and family, and a permanent part of the medical record. If instituting an electronic medical record is not feasible in your practice, having asthma action plans that are preprinted with medication names allowing you to check off or circle the treatment prescribed or having asthma action plans with a preprinted short-acting beta-agonist so that you only need to write the long-term control medications are 2 time-saving options. Creative shortcuts can also be useful. For example, color-coded labels for long-term control and quick-relief medications can be preprinted and then added to the action plan at the end of the visit. An example of such a plan can be found in Figure 39-1. All action plans described allow for individualization in an efficient manner.

Figure 39-1.Sample written asthma action plan with preprinted labels. 

Having written asthma action plans is only one step in the process for enhancing education in your office; using them is an even more important step. To encourage use of the action plans in your office, it is important to keep them readily available. Some suggestions include keeping the asthma action plans in each exam room so that they are easily accessible during each patient visit or having them clipped to the front of each asthma patient’s chart before the visit begins.

Another method for enhancing education in your practice is to make resources available to your patients and to view each opportunity as a teachable moment. For example, providing patients and families with internet opportunities (such as the Quest for the Code asthma game found at www.asthma.starlight.org) for self-education while they are sitting in the waiting room or providing them with a list of resources (Table 39-1) that they can access at their convenience allows them to learn at their own pace. However, it is extremely vital to recognize that merely providing patients and families educational materials without providing explanation is not true education. All educational materials and resources provided to patients must be reviewed and reinforced by all members of your health care team. One way to accomplish this is to develop asthma-specific visit forms that include a list of key educational messages. This list can be used to prompt providers to introduce or review a message or messages at each visit. Thus, providing consistent and repeated educational messages by all members of your health care team is another step to enhancing education in your practice.

 

An alternative or supplementary method for providing self-management education and addressing key educational messages is to offer asthma education classes and resources in your office. Asthma education classes allow you to personally review important self-management concepts in a group setting, thus promoting efficiency as well as education. Numerous examples and forms (print, audio-video, online) of asthma educational resources are available that can also be tailored to meet the needs of an individual practice.

Two final recommendations for enhancing education in your practice include hiring a nationally certified asthma educator to provide education during patient visits as well as via telephone in between visits, and developing a system for referring patients who need additional education to asthma specialists. Both of these strategies are supported by the NAEPP EPR-3 Guidelines. The Guidelines recommend using health professionals and others trained in asthma self-management education to implement and teach asthma self-management. They also recommend referring patients who need additional education to improve adherence to asthma specialists.⁵National certification for asthma educators has been available since 2002; thus, it is relatively new, and the effectiveness of education provided by certified asthma educators has not been reported. However, numerous randomized controlled studies have reported improved asthma outcomes when patients and families were educated by someone specially trained in asthma care and self-management.⁶

Summary

There are many options for enhancing education in your practice; some are more labor-intensive and costly than others. Developing a system that fits within the confines of your practice makes quality asthma education accessible to all of your patients with asthma and their families, and using all members of your health care team is the best approach to enhancing asthma education in your practice.

Read article here.

Impulse Oscillometry Offers Hope of Early Diagnosis of Asthma

Impulse oscillometry is an advanced lung function testing method that allows early asthma diagnosis and better prediction in loss of asthma control.  Dr Susarla

Impulse Oscillometry Offers Hope of Early Diagnosis of Asthma

A study led by researchers at NIAID suggests that impulse oscillometry (IOS), a non-invasive method for measuring lung function, is more effective in detecting asthma in children than spirometry, the commonly used method. The results appear in the August 2011 issue of Pediatric Pulmonology.

Background

A child uses an IOS machine to measure lung function. Credit: NIAID

Jason¹ was only 3 years old when he first arrived at the Pediatric Allergy Clinic at the National Institutes of Health (NIH), in Bethesda, Maryland. He had a history of severe allergic reactions to food and suffered from chronic atopic dermatitis, also called eczema. Recently, he had developed recurrent coughing and wheezing. His doctor suspected asthma and prescribed daily use of inhaled corticosteroids.

Before adding another drug to Jason’s daily regimen, his parents wanted conclusive proof that he had asthma. The standard test used to diagnose asthma, called spirometry, requires that a person exhale vigorously into a machine for 10 to 15 seconds. As a result, younger children and some adults with physical impairment may not be able to use the test. Because of Jason’s age, he would have to wait two to three years before he could take a lung function test to confirm his doctor’s diagnosis.

“A challenge for clinicians is how to make an accurate diagnosis in cases when the patient is not capable of performing the test required for that diagnosis,” said Hirsh D. Komarow, M.D., of the NIAID Laboratory of Allergic Diseases.

New Technology

IOS is a newer method of measuring lung function that has gradually been gaining acceptance by clinicians. The IOS machine works by producing small-pressure oscillations (vibrations) that are applied at the mouth and transmitted into the lungs. Measuring how the respiratory system responds to these impulses during natural breathing provides an indirect analysis of lung function. Unlike spirometry, IOS is non-invasive and easy-to-perform and requires minimal assistance from the patient.

“IOS offers several advantages over spirometry in the evaluation of young children in clinical practice,” said Dr. Komarow, “We sought to answer the question: Are the test results obtained from IOS as accurate as those produced by spirometry.”

Study Results and Significance

Dr. Komarow’s study compared results from lung function tests measured by IOS and by spirometry in 117 children who already were receiving medical care at the NIH Pediatric Allergy Clinic.

“The data were conclusive,” said Dean Metcalfe, M.D., chief of the Laboratory of Allergic Diseases, “In these children, IOS was not only more sensitive than spirometry, it was more specific in identifying children with asthma.”

This is a promising advance in asthma care. Asthma is a chronic lung disease that affects more than 22 million people in the United States, including nearly 7 million children under age 6. Early diagnosis of asthma promises several benefits: parents are able to more closely monitor their child for respiratory symptoms that may worsen asthma; doctors can track the course of the disease over a longer time period to better predict its outcome; and there are studies that indicate that beginning asthma treatment at a younger age improves long-term control of the illness.

Dr. Komarow examined Jason using IOS and in moments confirmed that Jason had asthma.

“I was pleased that Jason could be evaluated with IOS at the clinic,” said Dr. Komarow, “We made an objective diagnosis and he is receiving appropriate treatment to manage his asthma. This would not have been possible without IOS.”

Read article here.

Spring Can Be Especially Challenging For Asthma Patients

Spring is both a beautiful and ominous time, depending upon whether you are sensitized for allergies.  For children with asthma, it can especially be problematic since children with asthma are often likely to have coexisting allergies.  Below is a summary of allergies and asthma and an often misunderstood problem known as small airways disease. Dr. Susarla

Spring Can Be Especially Challenging For Asthma Patients Spring Allergies May Trigger Increased Inflammation in the Airways

(NAPSI)—While many people are excited about the warmer weather and blooming flowers that springtime brings, nearly 40 million Americans are also preparing for the onslaught of seasonal allergy symptoms. For some, springtime allergies can feel like a cold that just won’t go away, but for others, spring allergies can be a trigger for more serious respiratory conditions like asthma. People with asthma can experience chronic inflammation in both their large and small airways, which in turn can make the airways of the lungs very sensitive. Similar to tree limbs, the airways of the lungs are divided into “branches,” or bronchial tubes that begin with the large, main bronchi and then break off into many small airways in the lungs. Increasing evidence suggests that these small airways, when inflamed, may play a significant role in contributing to asthma symptoms and attacks. If inflammation is not treated properly, each time the airways are exposed to triggers, like pollen or other spring allergens, the inflammation increases and asthma symptoms are more likely to occur. There have been many advances in drug delivery over the past several years, which have led to the availability of treatments that target the small airways in particular—and when used daily, as prescribed, have the ability to improve asthma control. “About half of all asthmatics also have allergies,” said Dr. LeRoy Graham, pediatric pulmonologist at Georgia PediatricPulmonology Associates. “Spring allergies may seem like a small inconvenience to some people, but for a person with persistent asthma, allergy season can be very problematic, particularly among people who may not have been keeping up with daily asthma treatments before spring allergies hit. During spring allergies, daily asthma management is critical to help reduce inflammation in the large and small airways of the lungs and control asthma.” While inflammation can be a defense mechanism for the body, it can also be harmful if it occurs at the wrong time or lingers when it is no longer needed. When allergens, like pollen, are inhaled, the body can mistake them for an invader and attack them. When this occurs, the body produces chemicals that cause inflammation around the allergen to isolate and destroy it. The airways of people with asthma are even more sensitive to allergens, which can cause the inner linings of the airways to become inflamed, leaving less room for air to move through. Additionally, the muscles surrounding the airways tighten up and the mucus glands in the airways may produce thick mucus, which can further block the large and small airways. While asthma is a chronic condition and has many triggers beyond just spring allergens, it can be successfully managed and may not hinder people from doing the things they enjoy. A new website, www.GetSmartAboutAsthma.com, offers tips about managing asthma and inflammation in the large and small airways. The website also offers downloadable materials, like a symptom tracker, doctor discussion guide and asthma diary, so that patients can track their own asthma symptoms and triggers, during spring allergy season and throughout the year. Read article here.

Junk food linked to asthma and eczema in children

Asthma is a complex chronic medical condition with many genetic and environmental contributors.  Although food exposure does not suggest cause, research like this is certainly relevant and deserves attention.  Dr. Susarla

The high saturated fat levels in food such as burgers lower children's immune systems, it is believed.

A research project involving more than 50 countries found that teenagers who ate junk food three times a week or more were 39 per cent more likely to get severe asthma. Younger children were 27 per cent more at risk.

Both were also more prone to the eye condition rhinoconjunctivitis, according to The Sun newspaper

But just three weekly portions of fruit and vegetables could cut that risk by 14 per cent in the younger group and 11 per cent among the teens, it is believed.

Researchers from New Zealand's Auckland University looked at the diets of 181,000 youngsters aged six to seven and 319,000 aged 13-14.

The scientists then asked if the children had allergy symptoms.

They wrote in the journal Thorax, where the study is published: "Fast food may be contributing to increasing asthma, rhinoconjunctivitis and eczema.

"Regular consumption of fruit and vegetables is likely to protect against these diseases."

In the UK alone 1.1 million children already suffer with asthma and one in five get eczema.

The team of researchers warn that their results do not prove cause and effect.

Read article here.

Can Eating Your Veggies Prevent Asthma?

This is an interesting study, especially for patients/parents who always ask me what can be done "naturally" to prevent asthma.  As always, it is not clear if there is cause and effect.  However, reducing airway hyperresponsiveness, or the tendency for airway to constrict, is on the main goals of asthma therapy.  Dr. Susarla.

Low vegetable intake is associated with allergic asthma and moderate-to-severe airway hyperresponsiveness

Abstract

Background

In recent decades, children's diet quality has changed and asthma prevalence has increased, although it remains unclear if these events are associated.

Objective

To examine children's total and component diet quality and asthma and airway hyperresponsiveness (AHR), a proxy for asthma severity.

Methods

Food frequency questionnaires adapted from the Nurses' Health Study and supplemented with foods whose nutrients which have garnered interest of late in relation to asthma were administered. From these data, diet quality scores (total and component), based on the Youth Healthy Eating Index (YHEI adapted) were developed. Asthma assessments were performed by pediatric allergists and classified by atopic status: Allergic asthma (≥1 positive skin prick test to common allergens >3 mm compared to negative control) versus non-allergic asthma (negative skin prick test). AHR was assessed via the Cockcroft technique. Participants included 270 boys (30% with asthma) and 206 girls (33% with asthma) involved in the 1995 Manitoba Prospective Cohort Study nested case-control study. Logistic regression was used to examine associations between diet quality and asthma, and multinomial logistic regression was used to examine associations between diet quality and AHR.

Results

Four hundred seventy six children (56.7% boys) were seen at 12.6 ± 0.5 years. Asthma and AHR prevalence were 26.2 and 53.8%, respectively. In fully adjusted models, high vegetable intake was protective against allergic asthma (OR 0.49; 95% CI 0.29–0.84; P < 0.009) and moderate/severe AHR (OR 0.58; 0.37–0.91; P < 0.019).

Conclusions

Vegetable intake is inversely associated with allergic asthma and moderate/severe AHR. Pediatr Pulmonol. 2012; 47:1159–1169. © 2012 Wiley Periodicals, Inc.

Read abstract here.

Asthma attack led to teen's death

The rule is asthma-related deaths are avoidable, which makes stories like this shocking.  Even mild asthma requires routine evaluation.  Dr. Susarla

Asthma attack led to teen's death

Family and friends remember JheVontae Davis

CHESAPEAKE, Va. (WAVY) - Family members of a Chesapeake teen who died after football practice say the teen complained of chest pain before he collapsed earlier this week.

According to family members, 14-year-old JheVontae Davis, who played JV football at Oscar Smith High School, complained of a cough and chest pain before he collapsed at practice. Davis was diagnosed with severe asthma when he was a baby. 

"Early on, it was more intense, and he had to frequent the hospital multiple times," said Jamal Vaughn, Davis' cousin. "But as he grew older, the asthma became more controllable, to the point where he was able to just have his inhaler."

Davis used a breathing machine to sleep at night, but the asthma never crippled his competitive nature or his love for sports, especially football.

At Friday's varsity football game, Oscar Smith's team took a knee and prayed over Davis' jersey. The announcer called for a moment of silence and, in the fence, students used cups to draw a heart around the number Davis wore when he played.

"The moment of silence and the player that wore his jersey, it was just like, man, it was a very touching moment for myself, because he touched so many hearts," said Vaughn, who was a father figure in Davis' life.

He remembers Davis' plans to go to college. He says the teen had so much living left to do.

"We had our whole life planned out and what we wanted to do," said Zyuanya Laguerre, Davis' younger cousin. "I never thought that was the last time I was going to say goodbye to my cousin." 

Read article here.

RSV Hides in the Lungs AFTER Infection - Can Cause Asthma

Common Respiratory Syncytial Virus May Hide In The Lungs, Lead To Asthma, Researchers Report

Dr. Asuncion Mejias has shown that RSV may hide in the lungs even after other symptoms abate, ultimately resurfacing to cause recurrent wheezing and chronic airway disease. (Credit: Image courtesy of UT Southwestern Medical Center)

ScienceDaily (Oct. 22, 2008) — Conventional wisdom has been that respiratory syncytial virus (RSV) – a common virus that causes infection in the lungs – comes and goes in children without any long lasting impact.

A study conducted in mice by UT Southwestern Medical Center researchers, however, suggests that RSV may hide in the lungs even after other symptoms abate, ultimately resurfacing to cause recurrent wheezing and chronic airway disease.
"This research suggests that there's a potential new mechanism for asthma related to viral infections in children that could be associated with RSV," said Dr. Asuncion Mejias, assistant professor of pediatrics at UT Southwestern and senior author of a study available online and in the Nov. 15 issue of the Journal of Infectious Diseases. "These findings could aid in the development of preventive and therapeutic interventions for children with recurrent wheezing due to a virus such as RSV."
RSV is the leading cause of viral respiratory infections and hospitalizations in infants and children worldwide. Half of all babies develop an RSV infection within the first year of life and practically all have had at least one RSV infection by age 3, said Dr. Octavio Ramilo, professor of pediatrics at UT Southwestern and study co-author. About 3 percent to 10 percent of infants with RSV infections develop severe bronchitis and require hospitalization.
Most children recover within a week, but RSV can cause repeated infections throughout life. There is currently no vaccine available.
Dr. Ramilo said the team's findings contradict the current thinking that ribonucleic acid viruses like RSV are easily destroyed. "Whether RSV persists in children remains to be seen, but the fact that the virus persists in mice is amazingly powerful," he said.
The most striking finding, Dr. Mejias said, is that the amount of virus detected in the lungs of the mice directly correlates with the severity of airway hyperreactivity. Airway hyperreactivity, or episodes of bronchospasms in humans, is the main characteristic of asthma.

article HERE