Author: lowes1

ARLINGTON, Va. (WUSA) — Tony Cook of Alexandria, Virginia, recalls the wheezing, hoarseness and sleeping woes along with many prescribed and failed medications and treatments he’s had since he was diagnosed with asthma as a child.

Tony explains that, at one point, he thought no medication would ever be enough to provide him with lasting relief.

He says, “I had a bucket of medications that I tried counting, but there were just too many.”

Tony says asthma impacted every part of his life.

“I couldn’t exercise as much or do things that other people were doing.”

Tony has now become the first patient after the FDA’s approval to undergo Bronchial Thermoplasty, which uses heat to help patients breathe.

Dr. David Duhamel, Director of Pulmonary Procedures at Virginia Hospital Center explains that Bronchial Thermoplasty “melts away” tissue in the airways that can constrict and spasm during an asthma attack.

“We don’t have any therapies that can deal with the smooth muscle. However, by doing BT, we ablate the smooth muscle using gentle heat and take it out of the equation,” explains Dr. Duhamel.

A tiny catheter is inserted into a bronchial scope. This allows doctors to unblock each of the smaller tubes in the lungs.

By increasing airflow, severe asthma patients can respond better to inhalers and oral medications.

“It will not cure their asthma. It will make a significant improvement in the quality of their life, their need for medications and the frequency and severity of their exacerbations,” says Dr. Duhamel.

Although Tony will still rely on medication, Dr. Duhamel hopes, “…by undergoing Bronchial Thermoplasty he will be able to lessen the severity of his exacerbations, his asthma attacks.”

Tony says he hopes the technique means his frequent missed days of work and trips to the emergency room are behind him.

“Even a very limited reduction in my symptoms would be helpful,” says Tony.

Childhood Asthma Treatment: Not One-Size-Fits-All: Study helps guide treatment choices

A new study has found the addition of long-acting beta-agonist therapy to be the most effective of three step-up, or supplemental, treatments for children whose asthma is not well controlled on low doses of inhaled corticosteroids alone.

The study was designed to provide needed evidence for selecting step-up care for such children and was supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. Researchers also identified patient characteristics, such as race, that can help predict which step-up therapy is more likely to be the most effective for a child with persistent asthma.

The study found that almost all of its participants had a different response to the three different treatments. Although adding the long acting beta-agonist step-up was one and one-half times more likely to be the best treatment for most of the study group, many children responded best to other two treatments instead.

“These results fill an important gap in our asthma guidelines,” said NHLBI Acting Director Susan B. Shurin, M.D., a board-certified pediatrician. “At the time the guidelines were written, there were very few comparison studies conducted in children whose asthma was poorly controlled with low-dose inhaled corticosteroids. Now that we have these study data, we can more confidently make recommendations for these children.”

The NHLBI’s Guidelines for the Diagnosis and Management of Asthma (EPR-3) recommend three treatment options for children with mild to moderate persistent asthma – for example, those experiencing symptoms at least two days per week – whose asthma is not well controlled on low doses of inhaled corticosteroids. These treatments, which were featured in the study, are adding a long acting beta agonist to the low-dose inhaled corticosteroids; adding a leukotriene receptor antagonist to the low-dose inhaled corticosteroids; and doubling the dose of inhaled corticosteroids. These recommendations were based on data collected from adults.

The study, called Best Add on Therapy Giving Effective Responses (BADGER), compared how effectively the three different step-up treatments improved asthma control in 182 children ages 6 to 18 years. All participants had mild to moderate persistent asthma that was not controlled on low-dose inhaled corticosteroids. Participants received each of the three treatments, with each treatment period lasting 16 weeks.

Responses were measured based on three factors: number of asthma episodes requiring oral corticosteroids, number of days of well controlled asthma, and lung function as measured by the amount of air exhaled in one second.

Overall, adding a long-acting beta-agonist to inhaled corticosteroids was significantly more likely (1.5 times) to be the best step-up therapy as compared to adding a leukotriene receptor antagonist to inhaled corticosteroids or to doubling inhaled corticosteroids.

Nearly all the children responded differently to the three treatments, with 45 percent of children responding best to adding a long-acting beta-agonist, 28 percent responding best to adding leukotriene receptor antagonist, and 27 percent responding best to doubling the dose of inhaled corticosteroids.

The study also identified several patient characteristics that increased the likelihood of identifying which step-up treatment would be more effective for an individual child. For example, African-American study participants were equally likely to respond best to long-acting beta-agonist step-up or inhaled corticosteroids step-up, and least likely to respond best to leukotriene receptor antagonist step-up. For white participants, the addition of a long-acting beta-agonist was clearly the most likely step-up therapy to give the best response, with inhaled corticosteroids step-up the least favorable therapy.

In addition, a long-acting beta-agonist was more likely to be the most effective step-up therapy among children who started the study with high scores on the Asthma Control Test, a five-item health survey used to measure asthma control, and among those who did not have eczema, an allergic skin condition.

“This study underscores the fact that individuals respond differently to different therapies ” childhood asthma treatment is not one-size-fits-all,” said Robert F. Lemanske, Jr., M.D., of the University of Wisconsin Hospital-Madison, one of the principal investigators of the study and lead author of the paper. “It is important to monitor the child’s response closely and, if necessary, adjust therapy with one of the other options within this step of care before moving to a higher step of care.”

The benefit of adding a different class of medication may be because of a possible ceiling effect for low-dose inhaled corticosteroids in some children, Dr. Lemanske said.

The observed overall best performance of long-acting beta-agonist step-up should be weighed against the increased risk of severe worsening of asthma symptoms leading to hospitalization and, in rare cases, death, as noted in the U.S. Food and Drug Administration approved labeling for long-acting beta agonists. Although there were no safety differences among the treatments during this study, the researchers assert the BADGER trial was not designed or powered to evaluate long-term safety of long-acting beta-agonists in children.

“This is the kind of study that will advance strategies for personalized medicine and improve treatment for children who have asthma,” said James Kiley, Ph.D, director of the NHLBI Division of Lung Diseases.

According to the Centers for Disease Control and Prevention, almost 7 million children in the United States have asthma, a leading cause of hospitalizations and school absenteeism. Common asthma symptoms include wheezing, shortness of breath, chest tightness, and coughing. While there is no cure for asthma, most children who receive effective treatment are able to control symptoms.

The study was conducted by researchers with the NHLBI’s Childhood Asthma Research and Education Network (CARE) centers. The CARE Network was established in 1999 to evaluate treatments for children with asthma; study sites are Penn State College of Medicine, Hershey, Pa.; National Jewish Health, Denver; University of Wisconsin – Madison; University of California, San Diego/Kaiser Permanente Medical Center; Washington University School of Medicine, St. Louis, Mo.; and University of Arizona College of Medicine, Tucson.

CARE centers also received support for this study from the National Center for Research Resources and the National Institute of Allergy and Infectious Disease, both part of NIH. Medications were provided by GlaxoSmithKline and Merck, Inc.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

GlaxoSmithKline has begun a new phase III study of Relovair, its new daily treatment for sufferers of asthma according to press reports and press releases on the GSK website.

The pharmaceutical company revealed that the first patient to participate in the trial has now commenced treatment with the drug, which is an inhaler-administered therapy based on the compound fluticasone furoate/vilanterol trifenatate.

It has been developed in partnership with biopharmaceutical firm Theravance as part of the two companies’ long-acting beta2 agonist collaboration, which commenced in 2002.

This study, which is taking place across Europe and the US, will aim to establish the safety and efficacy of Relovair while comparing its performance to that of existing treatments for the condition.

The company expressed confidence that the treatment can prove to be a beneficial option for patients suffering from the “serious and chronic disease”.

Last week, the company received marketing authorization from the European Medicines Agency for Revolade, its treatment for chronic immune thrombocytopenic purpura.

GlaxoSmithKline commences Relovair Phase III asthma programme

GlaxoSmithKline (GSK) announced today that the first asthma patient has commenced treatment with Relovair™ (fluticasone furoate/vilanterol trifenatate) in an asthma exacerbation study, marking the start of the Phase III clinical development programme with this once daily therapy, for this serious and chronic disease.

The asthma programme for Relovair (previously referred to as ‘Horizon’) will assess the potential benefit of the combination of inhaled corticosteroid, fluticasone furoate, and long-acting beta agonist, vilanterol trifenatate (642444) versus the component products and existing treatments for asthma.

The programme will consist of a range of eight studies to determine the efficacy and safety of Relovair in asthma patients who remained uncontrolled on current treatment. The initiation of the exacerbation study complements a 12-month safety study that is already underway in support of the COPD programme. An additional six efficacy studies, including three comparator studies, are scheduled to start within the next quarter.

GSK is in ongoing discussions with the FDA regarding the US component of the global asthma programme following the recent FDA Advisory Committee meeting and the FDA’s proposed changes to the use of LABA-containing products in asthma.

Study designs
The asthma exacerbation study is a randomised, double-blind, parallel-group study being conducted in Europe, the US and other international locations. This study will evaluate Relovair 100/25mcg against fluticasone furoate 100mcg in patients whose asthma remains uncontrolled on current therapy. The primary endpoint – time to first severe asthma exacerbation – will inform on both safety and efficacy. The ongoing 12 month safety study, will evaluate the overall safety profile of Relovair and has been designed to support both the asthma and COPD indications.

The additional six efficacy studies comprise: a 24 week head to head study of Relovair vs Advair/Seretide, a 24 week fluticasone furoate vs fluticasone propionate vs placebo study, a 12 week vilanterol trifenatate vs salmeterol vs placebo study, a 12 week low dose combination study and a 24 week higher dose combination study vs components and an HPA axis study.

Patients across all of the Relovair programmes will be dosed using a unique single step activation inhaler. This novel delivery device has been developed utilising GSK’s expertise in device development and valuable patient input.

Relovair is being developed under the long-acting beta2 agonist (LABA) collaboration entered into in November 2002 with Theravance, Inc. a biopharmaceutical company with a pipeline of internally discovered product candidates.