Detroit Medical Center (DMC) has been selected as the first Detroit area hospital to participate in a pivotal clinical study to evaluate the safety and effectiveness of a new therapy for patients with moderate to severe obstructive sleep apnea (OSA). The STAR trial (Stimulation Therapy for Apnea Reduction) will be conducted at leading medical centers across the United States and Europe, and will evaluate the efficacy of Inspire™ Upper Airway Stimulation (UAS) therapy, an implantable therapy that works with the body’s natural physiology to prevent airway obstruction during sleep.

More than 18 million Americans suffer from OSA, which is characterized by repeated episodes of upper airway collapse during sleep. Patients with OSA stop breathing frequently during sleep, often for a minute or longer. Daytime sleepiness, depression, weight gain, increase in industrial accidents and diminished quality of life are all commonly observed in people who suffer from OSA as a result of fragmented sleep patterns. Furthermore, OSA is associated with the development of systemic hypertension, cardiovascular diseases (heart failure, heart rhythm disorders), stroke, and diabetes.

Current treatment options for OSA include weight loss, CPAP, oral appliances, and surgeries. CPAP (Continuous Positive Air Pressure) applied through a nasal mask is the current standard of treatment for OSA. However several recent studies show that CPAP compliance can be as low as 50 percent because of the nasal mask constriction, discomfort and inconvenience.

The STAR trial will enroll CPAP intolerant patients. To be eligible for screening and inclusion in the STAR trial, patients must:

– Have failed or not tolerated CPAP

– Have moderate to severe obstructive sleep apnea

– Have a body mass index of less than 32

Detroit Medical Center will also be conducting a community health talk in September where interested patients can get more information and talk to the physicians involved in the clinical trial.

“Studies have shown that sleep apnea is as prevalent as adult diabetes and asthma and the consequences of OSA range from disruptive to life-threatening. While CPAP can be very effective to treat OSA, for many patients it is simply too difficult to comply with, and thus ineffective,” said M. Safwan Badr, M.D., Professor and Chief, Pulmonary Critical Care and Sleep Medicine, Department of Internal Medicine, DMC Harper University Hospital and Wayne State University School of Medicine.

“DMC was selected to participate in this study because of our extensive experience in treating patients who suffer from sleep apnea. We look forward to contributing to this important research to determine whether Inspire therapy can help the many people suffering from OSA with limited treatment options,” Dr. Badr added.

About Obstructive Sleep Apnea (OSA)

OSA is a common sleep disorder that occurs when the tongue and other soft tissues of the throat relax and obstruct the airway during sleep. Apnea events can occur multiple times per hour throughout the night, disrupting normal sleep. People suffering from OSA report significant daytime sleepiness and impaired quality of life. Depending on the degree of severity, OSA can be a potentially dangerous condition. OSA has been linked with increased risks for cardiovascular disease, weight gain and accidents resulting from daytime drowsiness. It is estimated that one in fifteen U.S. adults has moderate to severe OSA.

About Inspire™ Upper Airway Stimulation (UAS) Therapy

Inspire Upper Airway Stimulation (UAS) therapy is a dynamic, implantable therapy that works with the body’s natural physiology to prevent airway obstruction during sleep. While the OSA patient sleeps, Inspire therapy is designed to deliver physiologically timed, mild stimulation to the hypoglossal nerve on each breathing cycle. The stimulation is intended to restore tone to the muscles that control the base of the tongue, preventing the tongue from collapsing and obstructing the airway. Patients control when the therapy is turned on and off via a handheld programmer. In contrast to other surgical procedures to treat sleep apnea, Inspire therapy does not require removing or permanently altering an OSA patient’s facial or airway anatomy.

About The STAR Trial

The STAR trial is a global, multi-center clinical trial which will assess the safety and effectiveness of Inspire Upper Airway Stimulation (UAS) therapy in patients who suffer from moderate to severe obstructive sleep apnea (OSA). The trial will be conducted at leading medical centers throughout the United States and Europe.

For patients age 40 and over with chronic obstructive pulmonary disease (COPD), hospital readmissions within 30 days of initial treatment were 30 percent higher among blacks than Hispanics or Asians and Pacific Islanders and about 9 percent higher than whites in 2008, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

Based on data for patients who were hospitalized with COPD in 15 states during 2008:

– About 7 percent of patients were readmitted within 30 days principally for COPD, but 21 percent were readmitted for any health condition (all-cause readmission).

– There were 190,700 initial hospital admissions specifically to treat COPD at an average cost of $7,100. The average readmission cost principally for COPD was 18 percent higher, at $8,400 per stay, but all-cause readmissions were 50 percent more expensive than the initial stay–$11,100.

– Readmissions were 22 percent higher among patients from the poorest communities than among those from the highest income areas.

– Readmissions were about 13 percent higher among male patients compared to females.

Eating low-fat yoghurt whilst pregnant can increase the risk of your child developing asthma and allergic rhinitis (hay fever), according to recent findings.

The study will be presented at the European Respiratory Society’s (ERS) Annual Congress in Amsterdam on 25 September 2011. All the abstracts for the ERS Congress are publicly available online.

The study aimed to assess whether fatty acids found in dairy products could protect against the development of allergic diseases in children.

The researchers assessed milk and dairy intake during pregnancy and monitored the prevalence of asthma and allergic rhinitis using registries and questionnaires in the Danish National Birth Cohort.

The results showed that milk intake during pregnancy was not associated with increased risk of developing asthma and it actually protected against asthma development. However, women who ate low-fat yoghurt with fruit once a day were 1.6-times more likely to have children who developed asthma by age 7, compared with children of women who reported no intake. They were also more likely to have allergic rhinitis and to display current asthma symptoms.

The researchers suggest that non-fat related nutrient components in the yoghurt may play a part in increasing this risk. They are also looking at the possibility that low-fat yoghurt intake may serve as a marker for other dietary and lifestyle factors.

Ekaterina Maslova, lead author from the Harvard School of Public Health, who has been working with data at the Centre for Fetal Programming at Statens Serum Institut, said: “This is the first study of its kind to link low-fat yoghurt intake during pregnancy with an increased risk of asthma and hay fever in children. This could be due to a number of reasons and we will further investigate whether this is linked to certain nutrients or whether people who ate yoghurt regularly had similar lifestyle and dietary patterns which could explain the increased risk of asthma.”

According to the latest News and Numbers from the Agency for Healthcare Research and Quality (AHRQ), 2008 hospital readmissions within 30 days of initial treatment were 30% higher among black patients aged 40 years or above with chronic obstructive pulmonary disease (COPD), compared to those in Hispanics, Asians and Pacific Islanders and about 9% higher than in whites.

The authors used data from Statistical Brief #121: Readmissions for Chronic Obstructive Pulmonary Disease, 2008, from State Inpatient databases, including Virginia, Louisiana, Utah, Arkansas, California, Tennessee, Florida, Hawaii, , Massachusetts, Missouri, Nebraska, New Hampshire, New York, South Carolina, and Washington.

The findings revealed that of all patients readmitted within 30 days, 7% were readmitted mainly for COPD with 21% being readmitted for any health condition (all-cause readmission).

In total, hospitals admitted 190,700 initial COPD patients at an average cost of $7,100. The average readmission cost of $8,400 per stay for patients diagnosed principally for COPD was 18% higher, with all-cause readmissions being 50% more expensive than the initial stay, i.e. $11,100.

Patients from the poorest communities showed 22% higher readmission rates compared with those from the highest income areas.

Results also showed that male patients had a 13% higher readmission rate compared with females.

Petra Rattue

University of Utah engineers who built wireless networks that see through walls now are aiming the technology at a new goal: noninvasively measuring the breathing of surgery patients, adults with sleep apnea and babies at risk of sudden infant death syndrome (SIDS).

Because the technique uses off-the-shelf wireless transceivers similar to those used in home computer networks, “the cost of this system will be cheaper than existing methods of monitoring breathing,” says Neal Patwari, senior author of a study of the new method and an assistant professor of electrical engineering.

While he estimates it will be five years until such a product is on the market, Patwari says a network of wireless transceivers around a bed can measure breathing rates and alert someone if breathing stops without any tubes or wires connected to the patient.

“We can use this to increase the safety of people who are under sedation after surgery by knowing if they stop breathing,” he says. “We also envision a product that parents put around their baby’s crib to alert them if the baby stops breathing. It might be useful for babies at risk of SIDS.”

The American Academy of Pediatrics says there is “no evidence that home monitors are effective” for preventing SIDS. Since 2005, the group has opposed the use of breathing monitors to prevent SIDS, but has said they “may be useful in some infants who have had an apparent life-threatening event,” including some combination of apnea [abnormal interruptions in breathing], color change, limpness and choking or gagging.

“The AAP recognizes that monitors may be helpful to allow rapid recognition of apnea, airway obstruction, respiratory failure, interruption of supplemental oxygen supply, or failure of mechanical respiratory support,” the group states.

In addition to other possible uses, Patwari wants to conduct research with doctors to test his method as an infant-breathing monitor, and, if it proves useful, develop it as a medical device that would need federal approval. He also says it may be useful for adults with sleep apnea, which causes daytime fatigue and impairs a person’s performance.

SIDS monitors now on the market include FDA-approved medical devices that measure heart rate and respiration and are connected to babies with wires, electrodes and-or belts. Other monitors, which are non-medical and over-the-counter versions, detect a lack of sound, or use mattress sensors to detect a lack of movement.

Patwari says that with the new method, “the patient or the baby doesn’t have to be connected to tubes or wired to other sensors, so they can be more comfortable while sleeping. If you’re wired up, you’re going to have more trouble sleeping, which is going to make your recovery in the hospital worse.”

Some opposition to SIDS monitors is based on a fear that parents will depend on monitors instead of following other, more effective medical measures, including always placing babies on their backs to sleep, keeping redundant bedding and soft objects out of the crib, and not having babies share a bed with adults.

Yet many parents want monitors too. The AAP acknowledges “distribution of home monitors continues to be a substantial industry in the United States.”

New Uses for Wireless Technology

Wireless technology has become pervasive, from wireless phones to wireless networks linking home computers. In 2009, Patwari and then-graduate student Joey Wilson showed how a couple dozen wireless transceivers – devices that transmit and receive radio signals – could be used to literally see through walls to detect the location of a burglar, people trapped by a fire or hostages held captive inside a building.

They formed a University of Utah spinoff company, Xandem Technology LLC, which is commercializing the wireless networks for use as motion detectors for burglar alarm systems, to help police locate hostages and even to alert out-of-town, vacationing parents if a crowd of teenagers is partying at their home during their absence.

Patwari’s new study points out pros and cons of adding wireless detection of breathing to the motion-detecting capability.

“A search and rescue team may arrive at a collapsed building and throw transceivers into the rubble, hoping to detect the breathing of anyone still alive inside,” Patwari and colleagues write. “Police or SWAT teams may deploy a network around a building to determine if people are inside.”

“On the other hand, the ability to measure breathing from a wireless network has privacy implications,” they add. “We have shown previously that a network deployed around external walls of a building can detect and track a person who is moving or changing position. If this system can also detect and monitor a sleeping person’s breathing, it would have additional utility for eavesdroppers or thieves.”

The Study: Using Wireless Transceivers to Detect Breathing

Because of efforts to patent the new use of the wireless breathing-detection technology – which has been named BreathTaking – Patwari is posting his study on the online scientific preprint website ArXiv this week before submitting it to a journal for formal publication.

Patwari conducted the study with Wilson; Sai Ananthanarayanan, a postdoctoral electrical engineer; Sneha Kasera, an associate professor of computer science; and Dwayne Westenskow, a professor of anesthesiology and research professor of bioengineering. The research was funded by the National Science Foundation.

In a new study, Patwari showed a network of 20 wireless transceivers placed around a hospital bed could reliably detect breathing and estimate breathing rate to within two-fifths of a breath per minute based on 30 seconds of data.

This is different than using wireless transmitters to relay measurements from conventional breathing monitors. The motion of the chest and abdomen during breathing impedes the wireless radio signals crisscrossing a bedridden patient, who in the study was Patwari himself. Each of the 20 transceivers or “nodes” can transmit and receive to the other 19, meaning there can be up to 380 measurements (20 times 19) of radio signal strength within a short period of time (the transceivers transmit one after the other).

The study was conducted in a clinical room used for research at the University of Utah School of Medicine’s Department of Anesthesiology. Patwari reclined on a hospital bed and listened to a metronome to time his breathing so he inhaled and exhaled 15 times per minute – about the average breathing rate for a resting adult.

His breathing was measured two ways: by the experimental wireless network, and by a carbon dioxide monitor connected to his nostrils by tubes. It calculated breathing rate by measuring the amount of carbon dioxide exhaled with each breath. Patwari also tested the wireless network with no one in the hospital bed.

The study found the wireless network could measure breathing within 0.4 to 0.2 breaths per minute, an insignificant error rate given that most breathing monitors round to the nearest breath per minute, he says. If a bedridden person or baby moves, the wireless system detects the movement but cannot measure their breathing at the same time.

To decide if someone is breathing or not, the wireless system uses a computer algorithm – basically, a set of formulas. Patwari says his algorithm squares the amplitude or loudness of the signal on each link between nodes, then averages it over all 380 links. A number larger than 1.5 indicates breathing has been detected.

Patwari also measured how many nodes were required to measure breathing accurately. The minimum was 13 nodes or transceivers, while the rate of incorrect breathing measurements fell to zero when 19 nodes were used. The study also showed the height of the nodes around the hospital bed didn’t significantly affect breathing measurements.

Patwari plans more research on whether different or multiple radio frequencies might detect breathing better than the one 2.4 gigahertz frequency used in the study.

He also wants to test whether the system can detect two people breathing at the same rate but not in sync – something that might make it possible to design a system that could detect not only the location of hostages in a building, but the number held together.

Many of the people who died from the new strain of H1N1 influenza that broke out in 2009 were suffering from another infection as well: pneumonia. A new study published today, September 20 in the online journal mBio® reveals how the two infections, pandemic influenza and pneumonia, interact to make a lethal combination.

Back in 2009, autopsies of 34 of the victims of the H1N1 pandemic influenza virus revealed that about half showed signs of bacterial co-infection in their lungs. This was a telling sign that the two pathogens are playing off one another, but until now little was known about the biological interactions between them or why influenza was so lethal when accompanied by pneumonia.

Using mice, Kash et al., from the National Institute of Allergy and Infectious Diseases (NIAID) and the Institute for Systems Biology (ISB), teased the problem apart. They infected some mice with the seasonal flu virus and others with the 2009 pandemic strain and waited 48 hours for the influenza to take hold. Next, they exposed some of the mice to the bacterium Streptococcus pneumoniae, one of the leading causes of pneumonia.

In mice that were only given either of the flu viruses, influenza had the same effects it has in humans, including weight loss, but all the mice infected with influenza alone survived. The mice infected with seasonal influenza and S. pneumoniae had slightly enhanced lung tissue damage, but they all survived the dual infections.

In contrast, all the mice co-infected with both the 2009 pandemic flu and S. pneumoniae showed severe weight loss and 100% mortality. The lung tissues of the dead mice revealed that the alveoli were severely inflamed and the surfaces of the bronchioles were wiped clean of the protective layer of cells called the epithelium. There was also increased bacterial replication in the lungs of the co-infected mice, a sign that the bacteria were thriving there.

Looking at the mouse genes that were expressed during infection revealed more details about how the pandemic influenza virus sets the stage for lethal bacterial infections. Mice infected with the pandemic flu virus and S. pneumoniae had a similar inflammatory response as the other mice, but they lack responses that would repair and regenerate their damaged epithelial cells, those protective tissues that would otherwise keep bacteria from penetrating to deeper layers of tissue.

All these factors add up to big problems in the lung: as compared with seasonal flu, infection with the pandemic strain of flu was associated with more extensive damage to the epithelium that requires more extensive tissue repair. This opens the body up to attack from bacterial invaders, including Streptococcus pneumoniae.

Keith Klugman, who studies pneumonia and pneumococcal disease at Emory University, edited the paper. He says the study has a number of implications for treatment of pandemic flu.

“One implication is that if you can prevent the bacterial infection, you may be able to prevent a significant fraction of the pneumonia that leads to death. There may be a role for antibiotics in the severe pneumonias that follow influenza,” says Klugman.

Klugman points out that a vaccine for S. pneumoniae exists and that it is effective at interrupting transmission of pneumonia in the community. Now that we know pandemic flu causes increased susceptibility to pneumonia, says Klugman, we might head off deadly influenza-S. pneumoniae co-infections with more proactive vaccination programs.

Surgery to correct gastroesophageal reflux disease, or GERD, can preserve lung function in patients with end-stage pulmonary disease both before and after transplantation, according to a new study from the University of Pittsburgh School of Medicine. The findings, published in the Archives of Surgery, suggest that esophageal testing should be performed more frequently among these patients to determine if anti-reflux surgery is needed.

Many end-stage lung disease patients, particularly those with idiopathic pulmonary fibrosis or cystic fibrosis have GERD, and the reflux problem is very common after lung transplantation, said Blair Jobe, M.D., professor of surgery, Department of Cardiothoracic Surgery, Pitt School of Medicine. Also, GERD has been associated with bronchiolotis obliterans syndrome (BOS), which is a progressive impairment of air flow that is a leading cause of death after lung transplantation. Its cause is not yet known.

“It’s possible that reflux, which is due to a weak sphincter between the stomach and esophagus, allows acid and other gastric juices to leak back not only into the esophagus, but also to get aspirated in small amounts into the lungs,” Dr. Jobe said. “That micro-aspiration could be setting the stage for the development of BOS.”

Lead author Toshitaka Hoppo, M.D., Ph.D., research assistant professor, Department of Cardiothoracic Surgery, Pitt School of Medicine, stressed the importance of esophageal testing for reflux in patients with end-stage pulmonary disease. He noted that “almost one-half of the patients in our series did not have symptoms but were having clinically silent exposure to gastric fluid. Based on this finding, there should be a very low threshold for esophageal testing in this patient population.”

For the study, Dr. Jobe’s team reviewed medical charts of 43 end-stage lung-disease patients with documented GERD, 19 of whom were being evaluated for lung transplant and 24 who had already undergone transplantation. All the patients were on GERD medications at the time they were evaluated for antireflux surgery (ARS), which prevents fluid from leaking back into the esophagus. Prior to ARS, nearly half of the patients had either no or mild symptoms of GERD and only a fifth had the typical symptoms of heartburn and regurgitation.

The researchers found that nearly all measures of lung function improved after ARS in both the pre- and post-transplant groups. There also were fewer episodes of acute rejection and pneumonia after ARS in the post-transplant group.

“The surgery appeared to benefit even those who hadn’t yet had a transplant,” Dr. Jobe noted. “Given the shortage of donor organs, ARS might help preserve the patient’s own function and buy some more time.”

Emphysema is a lung condition in which tiny air sacs in the lungs – alveoli – fill up with air. As the air continues to build up in these sacs, they expand, and may break or become damaged and form scar tissue. The patient becomes progressively short of breath. Emphysema is a type of COPD (chronic obstructive pulmonary disease). The main cause of emphysema is long-term regular smoking.

The alveoli turn into large, irregular pockets with holes in them. The surface area of the lungs is gradually reduced, resulting in less oxygen entering the bloodstream.

The small elastic fibers that hold open the small airways leading to the alveoli also become destroyed. When the patient breathes out they collapse, i.e. the patient has problems exhaling air.

Emphysema is not curable, the condition cannot be reversed. However, treatment may slow down its rate of progression and alleviate symptoms.

The alveoli are the grape-like sacs

According to Medilexicon’s medical dictionary, emphysema is:

1. Presence of air in the interstices of the connective tissue of a part.

2. A condition of the lung characterized by increase beyond the normal in the size of air spaces distal to the terminal bronchiole (those parts containing alveoli), with destructive changes in their walls and reduction in their number. Clinical manifestation is breathlessness on exertion, due to the combined effect (in varying degrees) of reduction of alveolar surface for gas exchange and collapse of smaller airways with trapping of alveolar gas in expiration; this causes the chest to be held in the position of inspiration (“barrel chest”), with prolonged expiration and increased residual volume. Symptoms of chronic bronchitis often, but not necessarily, coexist. Two structural varieties are panlobular (panacinar) emphysema and centrilobular (centriacinar) emphysema; paracicatricial, paraseptal, and bullous emphysema are also common.
What are the signs and symptoms of emphysema
A symptom is something the patient feels and describes, such as pain, while a sign is something everybody can detect, such as a rash.

A patient with emphysema may experience no symptoms for many years. Eventually, as the condition progresses, there is a shortness of breath (dyspnea), which starts off gradually. An individual with early stages of emphysema may avoid physical activity because it makes them pant too much. Eventually, the shortness of breath is present even when the person is resting.
What are the causes of emphysema?
The main cause of emphysema is long-term, regular tobacco smoking. It may also be caused by marijuana smoking (much less common), exposure to air pollutions, factory fumes, coal and silica dust.

In rare cases, a patient may have inherited a deficiency of Alpha-1 antitrypsin, a protein that protects the elastic tissue in the lungs.
What are the possible complications of emphysema?
Pneumothorax, also called collapsed lung. This can be fatal in patients with severe emphysema because the lungs have become so weak.

Cor pulmonale – a part of the heart expands and becomes weak. This happens when pressure in the arteries that connect the lungs and heart increases.

Giant bullae – empty spaces, called bullae develop in the lungs. Giant bullae are very large, sometimes half the size of the lung. Not only does the lung have a much smaller surface area, the bullae can become infected. Patients with giant bullae are more likely to develop pneumothorax.

Recurring infections – chest infections, pneumonia, influenza, cold and the common cold are like to occur more often in patients with emphysema.

Pulmonary hypertension – abnormally high blood pressure in the arteries of the lungs.
Diagnosing emphysema
The doctor will carry out a physical examination and ask some questions, such as:

smoking status and history
whether he/she suffers from shortness of breath and how long for
what makes shortness of breath worse
whether there is a cough and if that cough brings up sputum
the patient’s medical history
whether his/her family have a history of lung disease

The doctor may order some tests, which may include:

Chest X-ray – this can help the doctor determine whether the emphysema is advanced, and also exclude any other reasons for the dyspnea.
CT (computerized tomography) scan – this may be ordered to help the doctor decide whether lung surgery is required.
Blood test – blood may be taken from an artery to determine how well the lungs are transferring oxygen into the blood, and removing CO2.
Lung function tests – these tests tell the doctor how well the patient’s lungs inhale and exhale air, as well as showing how much air the lungs can hold. The doctor will also have a better idea of how efficiently the lungs are transferring oxygen into the bloodstream. The patient will probably be asked to blow into a spirometer. Spirometry can be done at the doctor’s office or a nearby hospital or clinic. The patient has to blow as hard as possible into a small tube that is attached to a machine. The machine measures the time taken to blow all the air out of the lungs. If the patients airways are blocked it will take longer.

A modern USB PC-based spirometer [image from Wikimedia]
What are the treatment options for emphysema?
Emphysema is incurable; there is no treatment to reverse the condition. However, symptoms can be relieved and its progression can be slowed down with proper treatment.

Stop smoking – smoking is the main cause of emphysema in the first place. Stopping smoking will considerably slow down its progress.

Bronchodilators – types of medications that relax airways that have become constricted, thus relieving shortness of breath, breathing problems, and coughing. These drugs are more effective for the treatment of chronic bronchitis or asthma, but can help emphysema patients to some degree.

Steroid aerosol sprays – these are inhaled. Corticosteroids are effective for shortness of breath. However, they must be used under the careful monitoring of a doctor because long-term usage can result in weakened bones, elevated blood pressure and cataracts. Long-term steroid use also significantly raises the risk of developing diabetes.

Antibiotics – patients with emphysema generally get more infections, such as pneumonia or acute bronchitis than other people. Such conditions require antibiotic treatment.

Rehabilitation techniques – the patient can be taught certain breathing exercises that may help reduce shortness of breath and improve his/her ability to do exercise. Patients may undergo weight changes, which need to be addressed.

Oxygen – those with severe symptoms may require supplemental oxygen, which is usually administered through the nostril via a narrow tubing.

Surgery – a surgeon may surgically remove some of the damaged tissue, which helps the remaining lung tissue work better, this may help the patient breath better.

Lung transplant – when other options have not worked and symptoms are very severe, the doctor may recommend lung transplant

Original article date: 01 Jun 2004
Article updated: 22 Sept 2011

The US Food and Drug Administration (FDA) confirmed that the Decemember 31st 2011 ban on Chlorofluorocarbon (CFC) based asthma inhalers will go into force. The ban is part of the Montreal Protocol on substances that deplete the Ozone Layer., which dates back to international agreements made in the late 1980s. Since the protocol went into force in 1989 many products that use large amounts of CFC, such as refrigerators and deodorants have gone out of production.

Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. Confirmed :

“If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma.”

More importantly the ban will affect over the counter Epinephrine based inhaler marketed by Armstrong Pharmaceutical Inc. called Primatene Mist. This OTC product allows those with only mild asthma to treat themselves as and when they see fit. However it is the only FDA approved OTC product available on the market for asthma, leaving those who have been relying on it, needing to seek a doctor’s prescription for an alternative product.

Public discussions have been in progress since 2006, in regards to the CFC epinephrine inhalers and while most manufacturers have switched to the new hydrofluoroalkane (HFA) as an aerosol propellant in asthma inhalers, there is no product with HFA to replace the CFC based Primatene Mist.

The FDA has encouraged Armstrong Pharmaceutical Inc. to inform its consumers and Primatene Mist now carries alerts to warn consumers that it will be discontinued at year end. However as the deadline approaches it is obviously important to make sure the transition occurs without incident, as Asthma suffers that have been relying on the product will now need prescriptions. Doctors should be careful to alert patients to the changes.

More information is available on these links :

Phase Out of Epinephrine CFC Metered-Dose Inhalers

Epinephrine CFC Metered-dose Inhalers – Questions and Answers

Consumer Update: Primatene Mist with Chlorofluorocarbons No Longer Available After Dec. 31, 2011

Rupert Shepherd BSc.

Children with severe therapy-resistant asthma (STRA) may have poorer lung function and worse symptoms compared to children with moderate asthma, due to lower levels of vitamin D in their blood, according to researchers in London. Lower levels of vitamin D may cause structural changes in the airway muscles of children with STRA, making breathing more difficult. The study provides important new evidence for possible treatments for the condition.

The findings were published online ahead of the print edition of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

“This study clearly demonstrates that low levels of vitamin D are associated with poorer lung function, increased use of medication, worse symptoms and an increase in the mass of airway smooth muscle in children with STRA,” said Atul Gupta, MRCPCH, M.D., a researcher from Royal Brompton Hospital and the National Heart and Lung Institute (NHLI) at Imperial College and King’s College London. “It is therefore plausible that the link between airway smooth muscle mass and lung function in severe asthma may be partly explained by low levels of vitamin D.”

While most children with asthma can be successfully treated with low doses of corticosteroids, about 5 to 10 percent of asthmatic children do not respond to standard treatment. These children have severe therapy-resistant asthma, or STRA, experience more asthma episodes and asthma-related illnesses, and require more healthcare services, than their treatment-receptive peers.

Although previous studies of children with asthma have linked increases in airway smooth muscle mass with poorer lung function and in vitro studies have established a connection between levels of vitamin D and the proliferation of airway smooth muscle, this is the first study to evaluate the relationship between vitamin D and the pathophysiology of children with STRA.

“Little is known about vitamin D status and its effect on asthma pathophysiology in these patients,” Dr. Gupta noted. “For our study, we hypothesized that children with STRA would have lower levels of vitamin D than moderate asthmatics, and that lower levels of vitamin D would be associated with worse lung function and changes in the airway muscle tissue.”

The researchers enrolled 86 children in the study, including 36 children with STRA, 26 with moderate asthma and 24 non-asthmatic controls, and measured the relationships between vitamin D levels and lung function, medication usage and symptom exacerbations.The researchers also examined tissue samples from the airways of the STRA group to evaluate structural changes in the airway’s smooth muscle.

At the conclusion of the study the researchers found children with STRA had significantly lower levels of vitamin D, as well as greater numbers of exacerbations, increased use of asthma medications and poorer lung function compared to children with moderate asthma and non-asthmatic children. Airway muscle tissue mass was also increased in the STRA group.

“The results of this study suggest that lower levels of vitamin D in children with STRA contribute to an increase in airway smooth muscle mass, which could make breathing more difficult and cause a worsening of asthma symptoms,” Dr. Gupta said.

The findings suggest new treatment strategies for children suffering from difficult-to-treat asthma, he added.

“Our results suggest that detecting vitamin D deficiency in children with STRA, and then treating that deficiency, may help prevent or reduce the structural changes that occur in the airway smooth muscle, which in turn may help reduce asthma-related symptoms and improve overall lung function,” Dr. Gupta said.

Before any widespread treatment recommendations can be made, however, larger studies will need to be conducted to confirm the results, he added.

“The determination of the exact mechanism between low vitamin D and airway changes that occur in STRA will require intervention studies,” Dr. Gupta said. “Hopefully, the results of this and future studies will help determine a new course of therapy that will be effective in treating these children.”