Tuesday, March 3, 2009

To evaluate the sensitivity, specificity and predictive values of fractional exhaled nitric oxide (FENO) for the diagnosis of asthma in general practice.

Methods: Prospective diagnostic study with 160 patients attending 10 general practices for the first time with complaints suspicious of obstructive airway disease (OAD). Patients were referred to a lung function laboratory for diagnostic investigation.

The index test was FENO measured with a portable FENO analyser based on electrochemical sensor. The reference standard was the Tiffeneau ratio (FEV1/VC) as received by spirometric manoeuvre and / or results of bronchial provocation.

Bronchial provocation with methacholine was performed to determine bronchial hyper-responsiveness (BHR) in the event of inconclusive spirometric results.

Results: 88 (55%) were female; their average age was 43.9 years. 75 (46.9%) patients had asthma, 25 (15.6%) had COPD, 8 (5.0%) had an overlap of COPD and asthma, and 52 (32.5%) had no OAD.

At a cut-off level of 46 parts per billion (ppb) (n=30; 18.8%), sensitivity was 32% (95%CI 23-43%), specificity 93% (95%CI 85-97%), positive predictive value (PPV) 80% (95%CI 63-91%), negative predictive value (NPV) 61% (95%CI 52-69%) when compared with a 20% fall in FEV1 from the baseline value (PC20) after inhaling methacholine concentration <= 16mg/ml. At 76 ppb (n=11; 6.9%) specificity was 100% (95%CI 96-100%) and PPV was 100% (95%CI 72-100).

At a cut-off level of 12 ppb (n=34; 21.3%), sensitivity was 90% (95%CI 79-95%), specificity 25% (95%CI 17-34%), PPV 40% (95%CI 32-50), NPV 81% (95%CI 64-91%) when compared with a 20% fall of FEV1 after inhaling methacholine concentration <= 4mg/ml. Three patients with unsuspicious spirometric results have to be tested with FENO to save one bronchial provocation test.

Conclusions: Asthma could be ruled in with FENO > 46 ppb. Mild and moderate to severe asthma could be ruled out with FENO <12 ppb.

FENO measurement with an electrochemical sensor might be reasonable with respect to the time consuming procedure of bronchial provocation, which carries also some risk of severe bronchospasm. Further research is necessary to evaluate the effectiveness of this dual diagnostic strategy.

The number needed to diagnose might be improved when the diagnostic precision could be enhanced by future technical developments.

Author: Antonius Schneider, Lisa Tilemann, Tjard Schermer, Lena Gindner, Gunter Laux, Joachim Szecsenyi and Franz JOACHIM Meyer
Credits/Source: Respiratory Research 2009, 10:15

Saturday, February 21, 2009

COPD Exacerbations Increase the Likelihood of Repeat Exacerbations


New research shows that individual exacerbations in chronic obstructive lung disease (COPD) increase the likelihood of repeat exacerbations, even after 5 days of full, asymptomatic recovery.

"This concept that exacerbations are not random has important implication for the analysis of clinical trial data and identifies a specific high-risk period for recurrent exacerbation during which preventative interventions might be targeted," wrote lead author, John Hurst, MD, of the Royal Free and University College Medical School, London.

Prior to this research, exacerbations were assumed to be isolated events unrelated to one another despite observational data that suggested a dependency. In patients with COPD, exacerbations are generally defined as an acute worsening of symptoms, which can decrease lung function, ultimately driving the progression of the disease. Many patients never recover their baseline level of lung function after exacerbations.

To test the validity of this assumption, Hurst and colleagues analyzed daily symptom diaries that were kept for at least one year by 297 patients with COPD, describing nearly 2,000 distinct exacerbation events. Two or more new or worsening symptoms, one of which must be "major" (dyspnea, more sputum, or a change in color of sputum) constituted an exacerbation, and after 5 days of symptoms reverting to baseline severity, the exacerbation was considered to be over. A second exacerbation occurring within an 8-week period was considered to be a recurrent exacerbation. The researchers further analyzed seasonality of exacerbations, comparing their winter (November to January) frequency with their summer (June through August) frequency.

The researchers identified an 8-week period of time during which monitoring and follow-up is crucial to prevent or minimize further exacerbations in the COPD patient. "Our finding of a high-risk period for recurrent exacerbation may be important in guiding patient follow-up," wrote Hurst.

The researchers also found that exacerbations were significantly more common in the winter than the summer. They also noted that "isolated" exacerbations tended on average to be about 25% more severe than the first of serial exacerbations.

"The mechanisms of exacerbation recurrence remain unexplored, and it is unknown whether recurrence is due to persistence of an existing organism or to acquisition of a new one," said Hurst. "The failure to eradicate bacteria with exacerbation therapy has been associated with an incomplete recovery in inflammatory markers and we have recently reported a relationship between elevated C-reactive protein during the recovery period of an initial exacerbation and shorter time to the next."

Results of the study appear in the first issue for March of the American Journal of Respiratory and Critical Care Medicine.

Sunday, February 15, 2009

Roy Masters demonstrates the hidden hypnotic connection to smoking, and the one simple thing you need to learn and practice to stop permanently.

Smoking-related diseases claim an estimated 430,700 American lives each year. Smoking costs the United States approximately $97.2 billion each year in health-care costs and lost productivity. It is directly responsible for 87 percent of lung cancer cases and causes most cases of emphysema and chronic bronchitis.

Learn how to Quit smoking, cigarettes and other addictions in this simple lesson.


Friday, February 13, 2009

Emphasys Medical, maker of a valve that diverts air to only the healthy parts of lungs in emphysema patients, has put itself up for sale after the Food and Drug Administration rejected its lead product in December. This is the second relatively recent defeat for the Redwood City, Calif.-based company, which had to withdraw its IPO filing last May. Since then, all but five of its 50 employees have been laid off.

Tuesday, February 10, 2009

FDA Advisers Recommend Rejection of Airway Valve for Emphysema
By Emily P. Walker, Washington Correspondent, MedPage TodayPublished: December 05, 2008Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

GAITHERSBURG, Md., Dec. 5 -- An FDA advisory panel recommended today against agency approval of a first-of-its-kind one-way airway valve for emphysema patients, a device billed as a noninvasive substitute for lung volume-reduction surgery.
By an 11-2 vote, the Anesthesiology and Respiratory Therapy Device Panel found insufficient evidence of benefit to outweigh the risks of implanting the Zephyr Endobronchial Valve, manufactured by Emphasys Medical of Redwood City, Calif.
The panel was chaired by anesthesiologist David Birnbach, M.D., M.P.H., of the University of Miami. The affirmative votes were from two pulmonologists, Andrew Reis, M.D., of the University of California San Diego, and Philip Marcus, M.D., of the University of Arizona in Tuscan.
Drs. Marcus and Reis argued that the panel should recommend approving the device with some caveats, such as demanding an immediate post-market study, but the panel voted against approving the device with added conditions.
"Once you approve, the cat is out of the bag," said panel member Hugh Cassiere, M.D., director of the cardiothoracic unit at North Shore University Hospital in Manhasset, N.Y. "Approving a product just to continue research is not justified," he said.
But panel members seemed as upset as the company with the decision.
"It kind of breaks my heart to vote against this," said Stephen Li, Ph.D., of the Medical Device Testing and Innovations in Windsor, N.J. "The panel recognized how few options exist for emphysema patients."
"It's an interesting technology that is not ready for prime time," said panel member Thomas Vassiliades, M.D., of Emory in Atlanta, a cardiothoracic surgeon.
The FDA is not obliged to follow an advisory panel's recommendations but it usually does.
The Zephyr device is a removable one-way valve that is implanted by fiberoptic bronchoscopy into the diseased lobe in the lung. The purported mechanism of the valve is to reduce thoracic gas volume by preventing air from entering while still allowing trapped gas to escape.
The device limits the amount of air intake for an emphysema patient, and offers an alternative to the more risky lung volume reduction surgery for some patients, said pulmonologist Frank Sciurba, M.D., of the University of Pittsburgh, who was principal investigator for the key clinical trial, VENT.
For the Endobronchial Valve for Emphysema Treatment Trial (VENT), researchers randomized 221 patients to receive either the Zephyr endobronchial valve, or standard treatment. The tria l was multicenter, prospective, and unblinded.
The primary efficacy endpoint was at least a 15% change from baseline on two respiratory tests. The first test measured how much a patient could breathe out in one second while breathing as fast as possible, and the second tested how far a patient could walk in six minutes. Patients had these two tests at one, three, six and 12 months post-valve implantation.
The trial prespecified the six-month follow-up as the time to use to determine success of the treatment. At six months, the groups receiving the valve performed better on both tests than the control group (P=0.002 for breath test and P=0.019 for walk test), although the difference was much less than the prespecified 15% improvement.
At 12 months, the results of the 6-minute walking test dropped below statistical significance. Other secondary tests, including one to gauge quality of life, were also no different between the two arms at one year.
But perhaps the most striking result, according to pulmonologist Deborah Shure, M.D., Master FCCP, a consultant for the FDA, was the number of deaths in the valve group at six months. While no deaths were reported during that period in the control group, six patients died in the valve group before the half-year mark. All but one of those deaths was COPD-related. Dr. Shure gave a clinical review of the trial before the panel.
The mortality differences between the two groups are not so alarming considering that the valve group had twice the number of patients as the control group, said Armin Ernst, M.D., an interventional pulmonologist at Beth Israel Deaconess Medical Center in Boston, who spoke on behalf of Emphasys Medical. The company determined that there was not an increased mortality in the valve group.
But mortality rates aside (which were similar in the two arms at one year), other serious negative outcomes appeared to hit the valve group harder at the one-year mark.
The valve group had higher rates of serious adverse events related to COPD than the control group (23% versus 10%, P=0.01). They were also more likely to be hospitalized (39.7% versus 25.3%, P=0.024).
Ultimately, the panel agreed that the safety of the device was not the biggest issue.
"The risks are not huge," said Dr. Vassiliades, the panel member. "They are not insignificant either." But "the benefits are inadequate to overcome the risks."
"It's an irreversible disease," said Dr. Marcus. "What else can we really offer these people?"
The lead researcher of the trial said Emphasys likely will not continue on with its research.
"This was an $80 million study," said Dr. Sciurba. "There will be no resources for this company to complete it, and I fear this technology will die."
He said there are several other companies with similar technology, but this was, by far, the farthest along trial. (See: CHEST: Investigational Valve May Help In Emphysema)
"I feel it's a loss for choice in an otherwise bleak situation," Dr. Sciurba said after the vote.
Dr. Sciurba said he received no consultation fees from Emphasys. He is also an investigator on the NIH-sponsored National Emphysema Treatment Trial.

Saturday, February 7, 2009

from About.com Guide to COPD

Impact of Nutrition on Body Functioning in COPD
Friday February 6, 2009

While it is quite clear that good nutrition leads to better health, many of us wholeheartedly pay no heed to this fact as we joyfully pound down our Big Macs, triple Quarter-Pounders with cheese and 64 ounce Coca-Colas!
The truth is that a sound diet has many benefits, including weight reduction, higher energy levels, and a general improvement in overall well-being. But what about the affects of good nutrition on chronic obstructive pulmonary disease? Can a healthy diet alone actually prevent or somehow alter the course of this and other chronic lung diseases?
A recent study found that indeed, different dietary factors, (dietary patterns, foods, nutrients) do appear to be associated with COPD and its inevitable course. However, the study also found that other factors such as energy imbalance, muscle atrophy (from disuse), hypoxemia, systemic inflammation (inflammation affecting the entire body) and a mechanical disadvantage, are also known to contribute to the compromise of total body function in patients with COPD. Is the key then, to improve nutritional status and reduce these known, comprimising factors?
The study supported this idea, as it concluded that that nutritional intervention makes it possible to change the course and perhaps even the prognosis of COPD, but it MUST be combined with other interventional factors, including pulmonary rehabilitation, combining the use of bronchodilators effectively, controlling infection and exercise.
With this study in mind, here are some links that many help to improve your nutritional status and get you started on a basic, exercise plan:
Nutritional Guidelines for People with COPD
By Deborah Trendel, RN,

Thursday, February 5, 2009

NEW YORK, Feb 05, 2009 (BUSINESS WIRE) -- Reportlinker.com announces that a new market research report related to the Medical devices industry is available in its catalogue.
Home Medical Equipment Market in the US
http://www.reportlinker.com/p0100131/Home-Medical-Equipment-Market-in-the-US.html
US market to approach $8 billion in 2012
The US market for home medical equipment is forecast to increase nearly six percent annually to $7.9 billion in 2012. Growth opportunities will be divided among several groups of therapeutic and patient support products. Respiratory therapy equipment will remain the topselling product group based on the increasing prevalence of chronic obstructive pulmonary disease (COPD) and other conditions that cause breathing difficulties. Ongoing improvements in performance and portability features, coupled with widespread insurance coverage, will broaden the use of breathing-assist devices -- such as oxygen concentrators, liquid oxygen tanks and continuous positive airway pressure (CPAP) machines -- among home patients.
Home mobility devices demand to remain strong
Home mobility devices -- including wheelchairs, scooters, specialized lifts, canes and walkers -- will continue to see robust demand as aging demographic patterns lead to an increasing prevalence of orthopedic impairments. Upward trends in the number of orthopedic patients will also benefit growth opportunities for medical furniture and bathroom safety products. Efforts to control escalating health care costs will promote the transfer of IV drug delivery and dialysis procedures from medical facilities to patient homes, impacting favorably on home sales of IV pumps and accessories and peritoneal dialysis devices. An increasing emphasis on preventive medicine will broaden the home health care market for numerous patient monitors. Based on number of potential patients and potential to reduce health complications, monitors for blood glucose, blood pressure, and heart and respiratory functions will continue to post the largest demand. Additionally, home alert systems will form an attractive, rapidly growing niche in the marketplace as they enable most elderly individuals to live independently without direct supervised care.
More distribution channels, technology to support gains
Advances in technology, coupled with the expansion of distribution channels, represent two additional factors that will contribute to growth opportunities for home medical equipment. Advances in technology will increase the range of therapeutic and patient support equipment available for home applications. The diversification of medical facilities and retail establishments -- such as drug stores and mass merchandisers -- into home health care services is expanding the accessibility of home medical equipment to a widening percentage of the population.
Study coverage
This new industry study, Home Medical Equipment, presents historical demand data (1997, 2002 and 2007) plus forecasts for 2012 and 2017 by product type. The study also assesses key market environment factors, evaluates company market share and profiles 34 competitors in the US industry.